Colorectal Update Ohio Chapter- ACS
William C. Cirocco, MD, FACS, FASCRS FINANCIAL DISCLOSURES
NONE The AMERICAN PROCTOLOGIC SOCIETY (APS) d/b/a The AMERICAN SOCIETY of COLON & RECTAL SURGEONS (ASCRS) THE AMERICAN PROCTOLOGIC SOCIETY (APS)* 1899 AMA Meeting- Columbus, OH (Joseph Mathews AMA President ’99-’00) June 6 (Tuesday) - Great Southern Hotel (High & Main Streets) June 7-8 (Wednesday/Thursday)-Hotel Chittenden & St. Anthony’s Hospital-clinicals
1949 APS 50th Meeting (Columbus, OH) May 31- June 4 Deshler-Wallick Hotel
*1st APS President Joseph Mathews preferred the term “rectum and colon” instead because it clearly stated what the specialty was about (1923)
American Proctologic Society (APS)
▪ Purpose - to cultivate and promote knowledge of whatever relates to disease of the colon and rectum
▪ Make care of these maladies an acceptable part of practice (previously shunned by physicians)
▪ Stop quacks and charlatans FOUNDERS OF THE APS Joseph M. Mathews, Louisville APS President (1899-00,1913-14) James P. Tuttle, New York City(Vice Pres) APS President (1900-1901) Thomas C. Martin, Cleveland- OR APS President (1901-1902) *Samuel T. Earle, Baltimore - OR APS President (1902-1903) Wm M. Beach, Pittsburgh (Sec/Treasurer)APS President (1903-1904) *J. Rawson Pennington, Chicago- OR APS President (1904-1905) Lewis A. Adler, Jr., Philadelphia APS President (1905-1906) Samuel G. Gant, Kansas City APS President (1906-1907) *A. Bennett Cooke, Nashville APS President (1907-1908) George B. Evans, Dayton APS President (1908-1909) George J. Cook, Indianapolis APS President (1910-1911) B. Merrill Ricketts, Cincinnati Leon Straus, St. Louis Others: Charles C. Allison-Omaha, Joseph B. Bacon-Chicago,Krause-Cinc * “Board of Counselors” OR- in charge of operations Programme of the 1st Meeting of Rectal Specialists at Columbus, O. June 6-9, 1899
▪ “The importance of giving rectal diseases special study”- J Mathews, Louisville ▪ “Pruritus Ani”- James P. Tuttle, New York City ▪ “Surgical treatment of non-malignant stricture of the rectum”-J. Bacon, Chicago ▪ “A modification of Whitehead’s operation for hemorrhoids”-S. Earle Jr, Baltimore ▪ The proctoscope as a factor in Dx/Rx of simple rectal ulceration-Strauss,St. Louis ▪ “A consideration of the various forms of ulceration of the rectum”- Adler, Jr, Phila ▪ “Rectal carcinoma- excision and subsequent colotomy”- B.M. Ricketts, Cincinnati ▪ “The limitations of the Kraske operation”- Charles C. Allison, Omaha ▪ “The act of defecation”- Thomas Charles Martin, Cleveland ▪ “Constipation as considered from the standpoint of the proctologist”- A. Bennett Cooke, Nashville ▪ Paper and Exhibition of new instruments- Samuel G. Gant, Kansas City ▪ “Rectal adenomata”- William M. Beach, Pittsburgh Highlights of the APS Meeting
▪ Methods to inspect the rectum with new ‘mechanical devices’ ▪ X-ray methods to examine the intestine using Bismuth (Pennington, Chicago) ▪ Live clinic ▪ Operations (St. Anthony’s Hospital): Hemorrhoids (Sam Earle, Baltimore)
Early plans of the APS ▪ Grow membership
▪ Establish a journal (Cooke 1908, Murray 1910, Terrell 1923)
▪ Promote research and education in the nation’s medical schools
▪ Provide specialty training
▪ Create an objective certification process for specialists AMERICAN BOARD of PROCTOLOGY (ABP)
1935- ABP incorporated 1937- American Board of Surgery (ABS) incorporated 1938- application to ABMS deferred to ABS 1940- approved as subsidiary board of ABS 1949- petition granted – 17th independent board of ABMS 1949
1940 Recognition 1938 by ABS as the 17th Primary/ 1937 ABP Independent 1935 ABP approved ABMS Board as ABS American application 1933 Subsidiary Board of to ABMS 1930 American deferred to Board Board of Surgery (ABS) American ABS Proctology incorporated/ Board of th (ABP) ABMS 12 Medical ACS incorporated Primary Board officially Specialties recognizes (ABMS) Proctology organized as a specialty AMERICAN BOARD of MEDICAL SPECIALTIES (ABMS)- 24 PRIMARY BOARDS
1933 Founding Members (Ophthalmology, Otolaryngology, OBGYN, Derm) 1935 Orthopedic Surg, Pediatrics, Psych & Neurology, Radiology, Urology 1936 Internal Medicine, Pathology 1937 American Board of Surgery (ABS) - #12 1940 Neurological Surgery 1941 Anesthesiology, Plastic Surgery 1947 Phys Med & Rehab 1949 American Board of Proctology (ABP)- #17, Preventive Medicine 1969 Family Medicine 1971 Allergy & Immunology, Nuclear Medicine, Thoracic Surgery 1979 Emergency Medicine 1991 Medical Genetics
RECTAL CANCER National Accreditation Program for Rectal Cancer (NAPRC)
22 Local Recurrence in Rectal Cancer: 1980-2000s Colostomy Rates
Year(s) n Tumor Colostomy Source Country distance Rate from anal verge Norwegian 1993- 2136 Norway <12 cm 38% Rectal Cancer 1999 Project Dutch Trial 1996- 1805 Netherlands/Sweden <15 cm 32% 1999 MRC CRO-7 1998- 1350 UK/Canada/NZ/SAF <15 cm 35% 2005 German Trial 1994- 799 Germany <16 cm 25% 2002 Trans-Tasman 2001- 323 Australia/New <12 cm 33% 2006 Zealand AHRQ and 2002- 19,912 USA rectum 50% OSHPD (CA) 2004 Variability in the Outcomes of Rectal Cancer in the USA
▪ What operation is being done?
▪ Where?
▪ Who ?
▪ Is treatment evidence-based?
▪ Outcomes? WHAT? University of Minnesota Study 2007 ▪ NATIONWIDE INPATIENT SAMPLE ▪ 20% stratified random sample of U.S. inpatients ▪ 1988-2003
41,631 pts radical proctectomy
16,510 (40%) 25,121 (60%) sphincter-sparing colostomy
▪ Increase in sphincter-preservation rate from 27% in 1988 to 48% in 2003 ▪ Rate flat after 1999 ▪ Elderly, black, men, Medicaid, low-income zip code: predicted colostomy ▪ “most radical resections for rectal cancer in U.S. hospitals result in a colostomy”
Dis Colon Rectum 2007; 50:1119-1127 WHERE? How Experienced (in rectal cancer) is the Typical U.S. Hospital? Answer:
▪ NOT VERY! hospitals
CoC ▪ 70% of hospitals treat
< 20 patients/year
Percentage of of Percentage (n=1327) ▪ Only 30% of hospitals are “high volume” by common definition (>20 patients/year)
▪ Only 6% of hospitals treat > 50 patients/year
29 Are U.S. Rectal Cancer Patients Being Shifted to High Volume Centers?
Answer:
rectal patientsrectal ▪ No CoC
▪ More than half of patients
treated in hospitals that treat (n=21,393) Percentage of of Percentage <30 cases/year
▪ Only 25% of patients treated in the highest volume centers
30 Only 30% patients 72% of hospitals treated in “high” “low” volume volume hospitals
Hospital Volume
Outcome Low Medium High p value
Yearly case volume (avg) 1-5 6-10 11-24
Number of hospitals 232 65 24
Number of patients 2364 2686 2137
Mortality (%) 2.1 1.1 0.9 <0.001
Complications (%) 22 24 20 0.709
Sphincter preservation (%) 51 55 64 <0.001
Length of stay (mean # days) 9.7 9.2 8.8 <0.001
CALIFORNIA Office of Statewide Health Planning and Development database (2000-2005)
Mortality, colostomy rate, and LOS higher in low volume hospitals WHO? ▪ 11 states’ hospital discharge data 2003-2004*
▪ >7500 proctectomies by 2600 surgeons
▪ 40% of surgeons performed ONLY non-restorative procedures (APR) ! ▪ higher mortality rates (2x) and longer LOS (2 days)
▪ “Restorative” (LAR) surgeons were specialized by virtue of more pelvic pouch and anorectal operations
* Dis Colon Rectum 2011; 54:1210-5 ▪ Hospital discharge data from 21 states with county-level place of residence information (2002-04) ▪ 20,000 proctectomies ▪ 50% of cases non-restorative (APR) ▪ 26% counties > 60% APR rate ▪ Only 20% of counties with colostomy rate <40%
Agency for Healthcare Research and Quality Office of Statewide Health Planning and Development Calif.
Dis Colon Rectum 2010; 53:874-880 ▪ Tumor characteristics from SEER, ▪ “High Stoma Counties”(26% of screening rates from Medicare, all counties >60% APR rate) hospital characteristics from AHA, and surgeon specialty from ASCRS and SSO rosters ▪ Defined as >60% permanent colostomy (APR) rate (mean 71%) ▪ Less likely to have MRI or PET scanner “data support concept that surgeon ▪ Less likely to be teaching specialization and familiarity with hospital rectal cancer treatment are important ▪ Significantly fewer specialty determinants of rectal cancer care” surgeons
Dis Colon Rectum 2011; 54:207-13 What are the Oncologic Outcomes of Rectal Cancer Treatment in the U.S.?
▪ Local recurrence rates
▪ Disease-free survival Circumferential Resection Margin (CRM)
▪ Closest measured distance from outermost edge of tumor or involved lymph node to the mesorectal fascia (<1 mm = “involved”)*
▪ Powerful prognostic factor for local and distant recurrence and survival**
▪ Convenient and immediate quality measure for surgical technique and pre-treatment decision-making process
J Clin Oncol 2008;26:303-312
* College of American Pathologists 2011 **Nagtegaal and Quirke. J Clin Oncol 2008;26:303-312 National Cancer Data Base (NCDB): +CRM data
▪ NCDB 2010-2011
▪ Clinical stage I-III
▪ N=16,619 patients
▪ 17% with + CRM
▪ Variation by clinical stage and operation type ▪ No variation by facility type, volume, or NCRT
Rickles, et al. Annals of Surgery Establish CRM
Tumor spread at CRM
Satellite tumor deposits < 1mm of CRM = Positive CRM
Nagtegaal. J Clin Oncol 2005 Grading of the Specimen after TME
Mesorectal plane (a): The rectum is dissected from the pelvis en bloc with the mesorectum and the totality of its lymph nodes- resulting in a complete bulky mesorectum with only minor irregularities. Intramesorectal plane (b): The mesorectum is disrupted during the dissection and irregularities can be seen on its surface without exposure of the muscularis propria. Muscularis propria plane (c):The muscularis propria is exposed, and the circumferential margin of resection is at the muscle layer increasing the possibilities of encountering a positive margin.
Quirke, Lancet, 2009 Quality of Surgery & Pathology assessment: Lymph Node Yield
▪ Minimum of 12 lymph nodes is an internationally-accepted marker for quality of surgery and pathology assessment in rectal cancer*
▪ NCDB data 2008-2012 ▪ 53,911/59,653 (90%) patients with lymph node yield documented
▪ Rate of suboptimal lymph node yield (<12) was 36%
▪ Rate in patients receiving NCRT was 41% ▪ Rate in patients treated with surgery alone was 30%
*Lykke, et al. Int J Colorectal Dis 2015:30:347-351 Is Treatment Evidence Based?
▪ NCDB data 2006-2011 ▪ Clinical stage II/III rectal cancer patients (n=30,994)
▪ Examined adherence to evidence-based guidelines for neoadjuvant chemoradiotherapy (NCRT) use based on center type, volume, and geographic location
▪ Academic, Community, Comprehensive Cancer Center (CCC) ▪ Volume: Low (≤10/year), Medium (11-30/year), High (≥31/year)
Monson, et al. Ann Surg 2014; 260:625-632 Is Treatment Evidence Based?
▪ Adherence to guidelines for NCRT use suboptimal and variable
▪ Only 74% of stage II/III rectal cancer patients received NCRT (no improvement over time)
▪ Significant variation by hospital volume ▪ High 78% vs. Low 69% (p<0.001) ▪ 28% of hospitals treated >30 pts/year
▪ Significant variation by geography ▪ Midwest 76% vs. South 70% (p<0.001)
▪ No variation by hospital type
Monson, et al. Ann Surg 2014; 260:625-632 US Rectal Cancer Care (Summary)
▪ Suboptimal adherence to evidence-based guidelines for use of neoadjuvant therapy
▪ Suboptimal operations
▪ High rates of +CRM (surrogate marker for poor oncologic outcomes)
▪ U.S. outcomes inferior to European countries with national programs to improve quality of rectal cancer care US Rectal Cancer Care
Low-volume hospitals
Inexperienced High colostomy rates providers Advanced surgical procedures currently recommended to ‘Centers of Excellence’ (COE)
▪Liver transplantation ▪Whipple ▪High risk cancers diagnosed in low numbers (pancreas and esophagus) ▪? Rectal cancer (40,000 cases/year)
46 How best to optimize Rectal Cancer care?
▪Centralize Care vs ▪Standardize Care
47 How to optimize Rectal Cancer Care? European Approach ▪ European Model (Spain, Norway, Sweden, Switzerland, Netherlands, UK) ▪ Socialized Medicine (government payor) ▪ Centralized administration & national database ▪ Swedish county of Vastmanland*: Consolidation to single colorectal unit with recruitment of “university-trained” colorectal surgeon - Decreased LR - Increased survival
▪ * Khani MH, Smedh K. “Centralization of rectal cancer surgery improves long- term survival”. Colorectal Disease 2010;12:874-9
48 BARRIERS TO TRAVEL (N.Am.) ▪Time and space ▪Emergent cases (obstruction, perforation, etc.) ▪Co-morbidity ▪Patient age ▪Patient preference (near family) ▪Expense ▪Insurance (Medicaid, No Pay) ▪Who pays?? 49 The British Columbia (BC) Experience ▪ 1996 Provincial Cancer Registry: only 8 of 178 patients (4%) received neoadjuvant RT ▪ 80% of BC general surgeons attend course (1 year retention of information) ▪ Didactics, cadaver/video dissection & live video-linked surgery, difficult cases- multidisciplinary conference ▪ Surgeons may opt to refer to high volume centers ▪ Cite political, economic & patient-preference barriers to establishing centers of excellence ▪ 2000-04 increased neoadjuvant RT (43%-86%) and TME (35%-71%) ▪ Phang et al.”Effects of change in rectal cancer management on outcomes in British Columbia” Can J Surg 2010;53: 225-231. ▪ Phang et al.”Effect of systemic education course on rectal cancer treatment in a population” AJS 2011; 201: 640-644. 50 The Manitoba Experience ▪ 1997 Provincial Registry: only 3 of 333 (0.9%) of patients with rectal cancer received neoadjuvant RT: stoma rate >50%, LR rate >17% ▪ Only 1 RT unit in the province (Winnipeg) ▪ 2004-06 increased use of neoadjuvant RT from 4%- 25% decreased LR ▪ ‘Non-Winnipeg Manitoba’- LR rates remained high with decreased survival despite standardized multidisciplinary approach via provincial guidelines ▪ Main barrier to optimal rectal cancer care was access to RT (geography- 2nd RT unit Brandon) ▪ Latosinsky et al.”Local recurrence after rectal cancer treatment in Manitoba.Can J Surg 2009;52:45-50. ▪ Helewa et al.”Geographical disparities of rectal cancer local recurrence and outcomes: a population- based analysis”. DCR 2013;56: 850- 858.
51 The Alberta Experience ▪ High rates of LR and low rates of neoadjuvant RT use prompted 2001 Education Workshop (Bill Heald) ▪ Proportion of rectal cancer cases by ‘high-volume’ surgeon (>9 cases per year) increased from 32% to 68% (1996 – 2011) ▪ Use of neoadjuvant RT increased from 36% to 65% (1996 – 2011) ▪ By 2011, 72% “grade 3” (best) TME pathologic specimens ▪ 5-year LR rate decreased from 28% to 7% (1996 – 2007) ▪ This occurred WITHOUT a specific policy regarding consolidation of surgical care for rectal cancer (COE)
▪ Klingbeil et al.”Rectal cancer surgery by high volume surgeons results in improved oncologic outcomes and sphincter preservation” DCR 2013; 6: e264-65 [abstract]
52 Vermont Colorectal Cancer Registry
▪ Vermont Chapter of ACS ▪ Neoadjuvant RT among colorectal surgeons (CRS)- 91% versus 17% by general surgeons ▪ 70% of rectal cancer patients treated by CRS at the University of Vermont (Burlington) ▪ No mandate or directive from a central organization or agency to establish this practice pattern
▪ Hyman et al. “Understanding variation in the management of rectal cancer: the potential of a surgeon-initiated database”. AJS 2007; 194:559-562.
53 SUMMARY: SOLUTIONS ▪ Increased USE and ACCESS to RT ▪ Increased number (?) surgical specialists ▪ Surgical specialists confined to large cities with patient populations to support their practice (COE) ▪ Vs ▪ Increase surgical skills (TME) of general surgeons and/or concentrate rectal cancer cases to single (few) surgeon in practice group
54
Centralization vs Standardization of Rectal Cancer Care
▪ Optimal rectal cancer care “may only be possible in a dedicated center (COE) with appropriate skills set and resources” * ▪ Can “appropriate skills set (TME) and resources (RT)” be provided outside of a “dedicated center” of excellence (COE) for rectal cancer?
▪ * Monson et al. “Optimizing rectal cancer management: Analysis of current evidence”. DCR 2014; 57: 252-259.
56 Rectal Cancer ▪ Imaging ( Diagnostics ) Care ▪ Medical Oncology Multidisciplinary ▪ Radiation Oncology Key Components (Access) ▪ Surgeon ( ICU / ET ) ▪ Pathology ( CRM / TME )
57 MRI CRM EMV I
Solution: ASCRS and ACS Collaboration*
▪ The National Accreditation Program for Rectal Cancer (NAPRC)- under the direction of the ACS- CoC ▪ Under Development: - Education Module to set standards for pathology (synoptic), surgery (TME), etc - ACS/ASCRS data registry will begin with rectal cancer
▪ *Orangio GR. A national accreditation program for rectal cancer: A long and winding road. DCR 2018; 61: 145-146.
60 Washington U. ACOSOG Current St. Louis, MO Z6051 Study Years of Study 2001-2005 2008-2013 1999-2010
Patient Exclusions T4, ASA IV & V * Hx rectal ca Number of Patients 108 222 109 Race - 87% White 95% White Age, mean years (range) 61 ± 14 (21-94) 57 61 (28-88) Sex, number (%) Male 62 (57.4) 158 (66) 68 (62) Female 46 (42.6) 81 (34) 41 (38) BMI, mean (range) 29 ± 5 (19-44) 27 28 (16-47)
ASA Class, number (%) 1 5 (4.6) - 5 (4.5) 2 70 (64.8) - 48 (44) 3 33 (30.6) - 49 (45) 4 ˗ - 7 (6) Tumor Location “High” (8/10 – 12/15 cm) 28.7% 11.7% 6% “Middle” (4/5 - 8/10 cm) 36.1% 39.7% 39% “Low” (0 – 4/5 cm) 35.2% 48.5% 54% Neoadjuvant Therapy 82.4% 100% 100% Cirocco WC. Rectal resection following neoadjuvant therapy in a Midwest community hospital setting: The case for standardization over centralization as the means to optimize rectal cancer outcomes in the United States. Am J Surg 2019 ; 217 (3): 430-434. STUDY OUTCOMES (cont.)
Washington U. ACOSOG Z6051 Current St. Louis, MO Study Time for Operation 172.5 220.6 245.4 (range) (68-360 minutes) (139-392 minutes)
Estimated Blood Loss 420.6 318.4 471.4 (range) (75-1800mL) (50-2100 mL)
TNM Stage, number (%)
Complete Response (CR) 10 (11.2) 43 (19.4) 22 (20) 1 33 (37.1) 68 (30.6) 32 (29) 2 19 (21.3) 50 (22.5) 28 (26) 3 27 (30.3) 65 (29.3) 22 (20) 4 - 3 (1.4) 5 (5)
Cirocco WC.Rectal resection following neoadjuvant therapy in a Midwest community hospital setting: The case for standardization over centralization as the means to optimize rectal cancer outcomes in the US. Am J Surg 2019 ; 217 (3): 430-434. Washington U. ACOSOG Z6051 Current St. Louis, MO Study No. Harvested LNs (mean) 11.0 16.5 10.5 Rectal Anastomosis 73.1% 76.2% 56% Method of Coloanal Stapled - Hand-Sewn Anastomosis Anastomotic Leak Rate 7.3% 2.3% 6.6% Distal Resection Margin- Neg. - 98.2% 94% CRM- Negative 93.1% 92.3% - Time to Tol. 1st meal (mean) 4.0 days - 7.2 days Hospital LOS (mean) 8.8 days 7.0 days 9.2 days Complication Rate 44.4% 54.1% 42.2% 30 Day Mortality Rate 2% 1% 5% Readmission Rate 25.9% 4.1% 17% Median Follow-up Time 59 months - 75 months Local Recurrence Rate 4.2% - 3% 5-Year Overall Survival 88.5% - 78% 5-Year DFS 75.6% - 73% C Do the Elderly (>70) Tolerate Neoadjuvant Therapy?
To Completion (+/- interruption) ▪ Group 1 (<70) - 73/74 patients (99%) ▪ Group 2 (>70) - 30/35 patients (86%) ▪ P= 0.013
To Completion (without interruption) ▪ Group 1 (<70) - 66/74 patients (89%) ▪ Group 2 (>70) - 26/35 patients (74%) ▪ P= 0.053
Cirocco WC. Outcomes of rectal resection following neoadjuvant therapy in the elderly: Can patients be too old for a neoadjuvant approach? Am J Surg 2018; 215 (3): 436-439. Do the Elderly Tolerate Neoadjuvant Rx? To Completion (with interruption) ▪ Group 1 (<70) - 7/74 patients (9%) ▪ Group 2 (>70) - 4/35 patients (11%) ▪ P= 0.743
Incomplete ▪ Group 1 (<70)- 1/74 patients (1%)-completed 40 Gray RT ▪ Group 2 (>70)- 5/35 patients (14%)-completed 29-43 Gray RT ▪ P= 0.013
Complete RT only (Chemo not advised) ▪ Group 1 (<70) - 2 patients ▪ Group 2 (>70) - 2 patients
Cirocco WC. Outcomes of rectal resection following neoadjuvant therapy in the elderly: Can patients be too old for a neoadjuvant approach? Am J Surg 2018; 215 (3): 436-439. Rectal Cancer in the Elderly <70 years of age ≥70 years of age P-value Number of Patients (Total - 109) 74 35 Age, mean years (range) 52.8 (28-68) 77.6 (70-88) Sex, number (%) Male 48 (65) 20 (57) Female 26 (35) 15 (43) BMI, mean (range) 28.8 ± 6.6 (16.2-46.6) 25.9 ± 5.1 (16.1- 38.3) P= 0.02 ASA Class, number (%) 1 5 (7) 0 (0) 2 39 (53) 9 (26) 3 25 (34) 24 (69) 4 5 (7) 2 (6) Tumor Distance to Anal Verge, number (%) P= 0.8 0-5 cm 40 (54) 19 (54) >5-10 cm 30 (41) 13 (37) >10-15 cm 4 (5) 3 (8) Operation, number (%) APR (2 Proctocolectomies) 25 (34) 18 (51) Hartmann’s Procedure 2 (3) 3 (9) LAR + Loop Ileostomy 28 (38) 10 (29) Coloanal (all with loop ileostomy) 19 (26) 4 (11) Lymph Node Harvest, number (range) 11.1 (0-38) 9.4 (0-27) Time for Operation, mean minutes (range) 246.3 ± 55.9 (139-392) 243.9 ± 50.2 (151 -370) P= 0.8 EBL , mean mL (range) 495.0 ± 364.7 (50-2100) 389.3 ± 163.5 (150-800) P= 0.04 Days to Tolerating 1st Diet, mean days (range) 7.2 ± 3.5 (4-26) 7.3 ± 1.7 (5-10) P= 0.9
Length of Stay, mean days (range) 9.1 ± 4.0 (5-28) 9.7 ± 2.9 (6-19) P= 0.4 TNM Stage, number (%) P= 0.003 0 (Complete Response) 20 (27) 2 (6) 1 18 (24) 14 (40) 2 14 (19) 14 (40) 3 19 (26) 3 (9) 4 3 (4) 2 (6) Cirocco WC. Outcomes of rectal resection following neoadjuvant therapy in the elderly: Can rectal cancer patients be too old for a neoadjuvant approach? Am J Surg 2018 : 215 (3): 436-439. Lynch Syndrome Lynch Syndrome Cancer Risk by MMR Gene Mutation
Cancer Type MLH1 & MSH6 PMS2 General MSH2 Public Colorectal 40-80% 10-22% 15-20% 4.2%
Endometrial 25-60% 16-26% 15% 2.9%
Ovarian 4-24% 1-11% <<6% 1.5%
Stomach 1-13% <3% <<6% <1% Lynch Syndrome Screening Guidelines Cancer type Intervention Start age Interval Colorectal Colonoscopy 20-25 or 2-5 years prior Every 1-2 to the earliest diagnosis years if before age 25 Endometrial Transvaginal ultrasound 30-35 Annually with Endometrial biopsy & Ovarian Hysterectomy with After childbearing N/A bilateral salpingo- oophorectomy Gastric* Upper endoscopy 30-35 Every 2-3 years Urothelial** Urinalysis 30-35 Annually Skin & Brain Physical with exam and 21 Annually review of systems
* For LS patients with a family history of gastric cancer or Asian ancestry **For LS patients with a family history of urothelial cancer or men with MSH2 mutations RATE of METACHRONOUS CRC NUMBER of SEGMENTAL EXTENDED PATIENTS COLECTOMY COLECTOMY STATISTICAL STUDY Total/Seg/Ext #recurrent #recurrent SIGNIFICANCE (1st author) COUNTRY Year COLECTOMY CA/Total % CA/Total %
Mecklin Finland 1993 54 / 37 /17 8/37 = 22% 2/17 = 12% n.s.
Rodriguez-Bigas USA 1997 71 / --- /71 ---- 8/71 = 11% N/A
de Vos tot Nederveen Cappel Netherlands 2002 139 / 110 /29 13/110 = 12% 1/29 = 3% ----
Van Dalen USA 2003 93 / 70 /23 16/70 = 23% 0/23 = 0% ----
Natarajan USA 2010 83 / 54 /29 23/ 54 = 43% 4/29 = 14% P<0.006
Kalady USA 2010 264 / 221 /38 55/ 221 = 25% 3/38 = 8% P= 0.02
Parry ANZ/US/Canada 2011 382 / 332 /50 74/332 = 22% 0/50 = 0% P<0.001
Stupart South Africa 2011 60 / 39 /21 8/39 = 21% 2/21 = 10% P= 0.46
Cirillo Italy 2013 47 / 36 /11 11/36 = 31% 2/11 = 18% n.s.
Aronson Canada 2015 105 / 76 /29 22/76 = 29% 3/29 = 10% P= 0.036 Renkonen- Sinisalo Finland 2017 242 / 144/ 98 36/144 = 25% 5/98 = 5% P= 0.001
Kim Korea 2017 106 / 76/ 30 13/ 76 = 17% 0/ 30 = 0% ----
TOTALS 1641/1195/446 279/1195= 23% 30/446 = 7% PELVIC FLOOR/PROCTOLOGY SACRAL NERVE STIMULATION (SNS) REVIEW - SNS
1.Indications
2.Early Complications
3.Late Complications BRIEF REVIEW
▪ FI increasingly common problem
▪ 8.3% 40+ Population of US
▪ 2.8% Weekly Symptoms
▪ Previously “Silent Epidemic”
▪ Limited treatment options
Whitehead WE, Borrud L, Goode PS, et al. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009;137(2):512–517.e5172. doi:10.1053/j.gastro.2009.04.054 Therapeutic Options
▪ Laxatives vs. bulking agents
▪ Bowel regimen
▪ Pelvic Floor PT
▪ Injectables Therapeutic Options- SNS • 47% - achieved perfect continence by Wexner score • 42% - 100% improvement in FI episodes/week at 12 months • 25% had 75-99% improvement in FI episodes/week at 12 months • Resting/Squeeze pressures NOT significantly different on manometry Complications
Short Term: Long Term:
▪ Infection ▪ Direct trauma to device
▪ Presacral Bleeding ▪ Pain at Implantation site
▪ Pain implant site ▪ Lead Shift
▪ Pocket erosion ▪ Radiculopathy What percentage of patients need reoperation after SNS? Adverse Events (AEs)
▪ Reviewed all AEs reported to FDA as part of initial approval for FI (2011)
▪ n = 1954
▪ Re-operation rate- 18.4%
▪ Device explant- 50% of re-operations
Bielefeldt K. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration. World J Gastrointest Pharmacol Ther. 2016 May 6;7(2):294-305. doi: 10.4292/wjgpt.v7.i2.294. Adverse Events 2016 International Continence Society
Reoperation Rate - 15.6% - Lead migration - Pocket revision - Discomfort
Median time to reoperation = 216 DAYS COMPLICATIONS
n = 101
Widmann B, Galata C, Warschkow R, Beutner U, Ögredici Ö, Hetzer FH, Schmied BM, Post S, Marti L. Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study. J Neurogastroenterol Motil. 2019 Jan 31;25(1):159-170. MORBIDITY
▪ 37 patients- total
▪ 8/37 (22%) of patients required repeat operation
▪ 5/37 (13.5%) of patients required early reprogramming SNS MORBIDITY PROCTOLOGY: HEMORRHOIDS DEFINITION
▪ Gass and Adams (1950) - degeneration of supporting tissue in anal canal ▪ Buie (1960) - tumors/collections of varicose veins ▪ Goligher (1975) - varicosities of venous plexuses ▪ Dorland (1981) - varicose dilation of vein of the superior/inferior hemorrhoid plexus ▪ Thomson (1975) - ”vascular cushions”, demonstrable @ birth, normal anatomy ANAL CUSHIONS
Normal Anatomy (fetus/embryo) Consists of: ▪ Mucosa ▪ Submucosa ▪ Blood vessels ▪ Smooth muscle (Treitz’s muscle) ▪ Elastic connective tissue Deterioration of Connective Tissue
Deterioration of supporting connective tissue with age Gass-Adams 1955, Thomson 1975, Haas 1980, Loder et al. 1994
Vessels
Connective tissue
Increased anorectal pressure combined with deteriorated connective Fibers in submucosa tissue is often associated Fibers loose and broken with hemorrhoid disease of 9 year old boy In a 70 year old man causing prolapse (unable to support)
THROMBOSED HEMORRHOID
STAGE / DEGREE / GRADE BASED ON PROLAPSE
▪ GRADE 1- no prolapse ▪ GRADE 2- prolapse spontaneously reduce ▪ GRADE 3- prolapse manually reduces ▪ GRADE 4- prolapse cannot be reduced
3 TYPICAL LOCATIONS
▪ Right Anterior (most common) ▪ Right Posterior ▪ Left Lateral
ADVANTAGES of NON-EXCISION OPERATIONS
Hemorrhoid cushions contribute 15-20% to resting anal pressure (RAP) In select patients, loss of RAP may result in post- op fecal incontinence
OFFICE PROCEDURES
▪ Sclerotherapy ▪ Cryotherapy ▪ Infrared Coagulation (IRC) ▪ Rubber Band Ligation (RBL)
HEMORRHOIDECTOMY
▪ Doppler-Guided Ligation (THD/HAL-RAR) ▪ Stapled Hemorrhoidopexy (SH) ▪ Whitehead Hemorrhoidectomy ▪ Open/Excision & Ligation /Milligan-Morgan ▪ Closed (Ferguson Hemorrhoidectomy) ▪ New Energy Sources- LASER, Ligasure (Valleylab), Harmonic Scalpel (Ethicon) DOPPLER-GUIDED (DG) HEMORRHOID LIGATION
THD or DG-HAL+/- RAR DG HEMORRHOID LIGATION ( DG-HAL / THD )
Initial report of procedure by Morinaga et al, 1995 Hemorrhoidal dearterialization- proctoscope coupled with a doppler transducer to ligate terminal branches of SRA (Moricorn device) N=116 1 month follow-up ▪ Bleeding resolved in 96% ▪ Prolapse resolved in 78% THD
Ratto C et al, Evaluation of THD… DCR 2010;53: 803-811. Vascular branches of the superior rectal artery (SRA)
Location of the terminal branches of the SRA SRA
2-6 cm Doppler signal to Dentate line RECTAL ANAL REPAIR (RAR)
Step 2: RAR RAR / HEMORRHOIDOPEXY
Reposition prolapsed tissue RAR / HEMORRHOIDOPEXY
Complete pexy at least 1 cm proximal to dentate line to reduce post-op pain Reduces prolapse without excision Improves DG-HAL results- Grade 3 / 4 Increases post-op pain vs DG-HAL alone PRE & POST DG-HAL RAR
III degree III degree Before After
IV degree IV degree Before After
Ratto C et al, Evaluation of THD …. DCR 2010;53: 803-811. CONCERNS- DG-HAL
Lack of RCTs comparing DG-HAL Costs of DG-HAL is greater (Doppler) vs RBL and open hemorrhoidectomy Do arteries recanalize over time (?) ▪ 1 month after SH the arterial inflow to anal cushions is no longer interrupted by the stapled mucosal resection (Kolbert, 2002) INTERNATIONAL WORKING PARTY (Colorectal Disease- 2003)
OFFICIAL NAME:
“STAPLED HEMORRHOIDOPEXY” (SH) EVOLUTION OF ‘SH’
▪ PECK (1976) ▪ LEHUR et al (1989) ▪ G. ALLEGRA (1990) ▪ A. LONGO (1998) EVOLUTION OF “SH”
G. ALLEGRA - 10 patient series with circumferential internal hemorrhoids Inspired by the Whitehead Procedure
Presented @ AIVS Florence, Italy May, 1989 Published Giorn Chir (March, 1990) EVOLUTION OF ‘SH’
“ALLEGRA PROCEDURE”
▪ Pursestring through hemorrhoids ▪ Actual Hemorrhoidectomy ▪ Compable to the Whitehead Operation ▪ Fear of Post-Op: anal stenosis, ectropion, wet anus EVOLUTION OF ‘SH’
A. LONGO (June 3-6,1998) Treatment of Hemorrhoid Disease by Reduction of Mucosa and Hemorrhoid Prolapse with a Circular-Suturing Device: A New Procedure. Proceedings of the 6th World Congress of Endoscopic Surgery (Rome, Italy) 189 patients (1993-98)
LONGO RESULTS (1999)
Distilled by Cipriani & Pescatori* (186 pts) ▪ Almost no post-op pain (mean VAS- 2) ▪ Mean OR time- 6 minutes ▪ No sepsis ▪ No stricture ▪ No incontinence “Unfortunately no other article published in the literature confirm these data”
* Colorectal Disease 2002 RCT- ST. MARK’S
▪ SH does not deal with external disease (80% of pts) contrary to initial publications- “a major shortcoming of the technique” ▪ New Sx at long-term follow-up ▪ Mechanism for syndrome of pain/urgency is not clear ▪ SH is “technically demanding” eetham et al Lancet 2000;356:730-3. RCT- LONG TERM FOLLOW-UP
▪ Less pain in short-term ▪ Not earlier return to work ▪ Sx resolution at: 6 weeks - 69% Conventional, 53% SH 8 months- 69% Conventional, 36% SH
tam et al Lancet 2000;356:730-3. REVIEW OF RCTs*
▪ RESULTS SH vs. CONVENTIONAL: ▪ Shorter OR time ▪ Less pain ▪ Shorter return to work ▪ Higher recurrence for SH vs Conventional: 3rd Degree Hemorrhoids- 12% vs. 0% 4th Degree Hemorrhoids- 50% vs. 0%
* Nisar et al DCR 2004;47:1837-1845. RESULTS: SH vs MM at 1 YEAR
4th Degree Hemorrhoids SH MM
▪ Bleeding 14% 0% ▪ Tenesmus 32% 0%
Mattana et al DCR 2007; 50: 1770
3rd/4th Degree Hemorrhoids • Bleeding 40% 0%
Ortiz et al BJS 2002; 89: 1376 -1381 MULTICENTER RCT*-SH v. FERGUSON
RESULTS: ▪ Less pain at 1st BM ▪ Less early post-op pain (14 days) ▪ Less need for post-op analgesics ▪ Suture for bleeding- 84% SH (PPH 01) ▪ Recurrence: SH- 26%, Ferguson- 17.5% ▪ SH>Ferguson “new/worsening Sx” at 1 yr.
* agore et al DCR 2004;47:1824-36. REINTERVENTIONS FOR SH
▪ REOPERATION RATE- 11% (up to 45%) ▪ MOST FREQUENT INTERVENTIONS for: Persistent Severe Pain (VAS>7)- 44% Severe Post-Op Bleeding- 35% Anal Fissure- 28% Prolapsing piles- 20% rusciano et al DCR 2004;47: 1846-51. BLEEDING RISK WITH SH
New model PPH-03 : staple closure decreased from 1.0 mm to 0.85 mm
18 FDA RECALL OF PPH 001/003
▪ Ethicon Endosurgery- voluntary, global recall for products manufactured from 8/16/11- 7/24/12 ▪ Recall initiated 8/3/12 (MDs 10/26/12) ▪ Class 1 recall (most serious type- ‘reasonable’ probability that product will cause serious, adverse health or death) ▪ Incomplete staple formation (rectal wall damage, sepsis & occlusion of anal canal) WARNING SIGNS OF SEPSIS
▪ Postoperative Fever ▪ Abdominal Pain ▪ Urinary Retention
Maw et al DCR 2002;45(6):826-8.
Incidence of Sepsis- 3 perf/4,635 = .07%
Herold & Kirsch Lancet 2000;356:2187. SEVERE LIFE-THREATENING SEPSIS (RATE PER YEAR)*
▪SH 1.75 ▪RBL 0.60 ▪Hemorrhoidectomy 0.25 ▪Sclerotherapy 0.20
*
POST-PPH SYNDROME
▪ Chronic proctalgia ▪ Tenesmus ▪ Fecal urgency ▪ Incontinence ▪ Rectal bleeding ▪ Obstructed defecation (stenosis) PATIENT SELECTION FOR SH
▪ Don’t overuse the procedure ▪ “Good patient selection remains the secret of success” ▪ Discouraged in: High-risk patients Patients who engage in anoreceptive intercourse
noo-Mensah & Kaiser AJS 2005;190:127 INDICATIONS
▪ Grade 3 Hemorrhoids - Circumferential or at multiple sites (RBL for single site) ▪ Patient prefers less pain/shorter period of disability despite higher recurrence vs. more painful conventional hemorrhoidectomy with lower recurrence ▪ Patients who fail RBL*
*JRT Monson DCR 2003;46:296-7. CONTRAINDICATIONS
▪ Grade 4 Hemorrhoids ▪ Patients who engage in anoreceptive sex ▪ Incontinence (potential ‘defecatory disturbance’- lasting tenesmus, urgency,incontinence to flatus) ▪ High-Risk Patients (ASA 3-4, age >70)* ▪ Prefer long-term resolution of their Sx despite the increased pain with conventional surgery
*airaluoma et al DCR 2003;46:93-99. ACUTE HEMORRHOIDAL CRISIS Strangulated/Incarcerated/Ischemic
▪ Suddenly irreducible circumferential Hd ▪ Pain is severe, urinary retention common ▪ Edema may progress- ulceration/necrosis ▪ Standard 3-quadrant hemorrhoidectomy ▪ Mucosa may be closed (if not necrotic) ▪ Abx not required ACUTE HEMORRHOID CRISIS CLOSED (FERGUSON) HEMORRHOIDECTOMY
▪ Effective removal ▪ Avoids open wound ▪ Prompt healing of wounds ▪ Diminished drainage ▪ Less post-op discomfort vs Milligan-Morgan (MM) ?
“OPEN” HEMORROIDECTOMY MILLIGAN-MORGAN (MM) or EXCISION & LIGATION (1930s)
▪ Lithotomy position ▪ The pedicle is stick-tied at dentate line ▪ The remaining wound is left open ▪ Gauze packing with rectal tube “CLOSED” or “FERGUSON” HEMORRHOIDECTOMY COMPLICATIONS ▪ Acute urinary retention- 2-36% (<250 mL) ▪ Bleeding- 0.03- 6% (10 d post-op, 1% OR) ▪ Infection- 0.5- 5.5% ▪ Skin tags- 6% ▪ Anal stenosis- 0-6% ▪ Incontinence- 2 -12% ▪ Fistula/fissure/impaction/incontinence<1% HEMORRHOIDECTOMY “OPEN” vs “CLOSED” (RCTs)
▪ No statistical difference: pain, LOS, complications ▪ Safe & effective
•Arbman G et al, Closed vs. open hemorrhoidectomy- Is there a difference? DCR 2000;43: 31-34. • Gencosmanoglu R,et al, Hemorrhoidectomy:Open or closed technique? A prospective RCT. DCR 2002;45:70-75. Potential Complications of Excisional Hemorrhoidectomy
SHORT TERM • Prolonged and severe post-op pain • Delayed return to work LONG TERM ▪ Anal stenosis ▪ Fecal incontinence POST-OPERATIVE ANAL STENOSIS
▪ S/P Hemorrhoidectomy - 90% ▪ Anorectal (Crohn’s Ds.) - 3.3% ▪ S/P Jejunal-Ileal Bypass- 2.8% ▪ Excision Rectal Tumors - 1.4% ▪ I&D complicated abscess- 0.9% ▪ Repair after parturition - 0.9% ▪ Sphincterotomy - 0.5% WHITEHEAD HEMORRHOIDECTOMY
▪ Whitehead (Manchester, England) - 1882 ▪ For extensive circumferential hemorrhoids ▪ Complete mucosal/submucosal excision ▪ Complications- stricture, ectropion, loss of sensation
NEW ENERGY SOURCES
▪ LASER ▪ HARMONIC SCALPEL (Ethicon) ▪ LIGASURE (Valleylab) LASER HEMORRHOIDECTOMY
▪ “painless”, “bloodless” ▪ Claims lack supporting data ▪ No better than conventional approach ▪ Special/ Expensive equipment ▪ Safety issues (eyewear) DCR 1993;36(11):1042 – 1049. LASER
▪ No decrease in post-op pain ▪ Impaired early wound healing ▪ Higher costs
* Senagore A et al. DCR 1993;36:1042-1049. HARMONIC SCALPEL HARMONIC SCALPEL
▪ 4 RCTs ▪ Postoperative pain-similar in 3 of 4 studies ▪ Increased costs: Handpiece- $350 Generator- $15,000
* Khan S et al, Surgical treatment of Hemorrhoids DCR 2001;44:845-849. * Tan JJ et al. Prospective, randomized trial comparing diathermy and harmonic scalpel hemorrhoidectomy. DCR 2001;44:677-679. * Armstrong DN et al, Harmonic scalpel vs electrocautery hemorrhoidectomy: A prospective evaluation. DCR 2001;44:558-564. * Chung CC et al, Double-blind, randomized trial comparing harmonic scalpel hemorrhoidectomy, bipolar scissors hemorrhoidectomy and scissors excision. DCR 2002;45:789-794.
LIGASURE CONVENTIONAL vs LIGASURE HEMORRHOIDECTOMY
▪ ‘Trend’ to less pain (primary endpoint) ▪ Faster return to work (stat. sig.) ▪ Other differences (EBL, OR time)- clinically irrelevant ▪ “Thermal spread” - Harmonic Scalpel = Ligasure
*Nienhuijs et al, Conventional vs Ligasure hemorrhoidectomy for patients with symptomatic hemorrhoids. Cochrane Database 2009 Kwok SY,Chung CC,Tsui KK,Li MK. A double-blind,randomized trial comparing Ligasure and Harmonic Scalpel hemorrhoidectomy. DCR 2005;48(2): 344-348. HEMORRHOIDS IN SPECIAL SITUATIONS - AVOID OR!
▪ Pregnancy (Acute thrombosis) ▪ Inflammatory Bowel Disease (IBD): Crohn’s Disease / Ulcerative Colitis HEMORRHOID OPERATIONS More Invasive Hemorrhoid tissue Conventional excised Hemorrhoidectomy
Rectal mucosal Stapled excised hemorroidopexy (SH)
No excision DG-HAL +/- RAR Less Invasive PROCTOLOGY: ANAL FISTULAS It’s time to retire Goodsall’s Rule: The Midline Rule is a more accurate predictor of the true and natural course of anal fistulas
William C. Cirocco, M.D. John C. Reilly, M.D.
Table 1. Literature Review- Location of the Primary (Internal) Opening PRIMARY (INTERNAL) OPENING LOCATION (%) Author(s) Country Year Number Midline Midline Midline of Posterior Anterior Patients Gant USA 1923 - 95 95 - Minor USA 1929 - 80 80 - Rankin, Bargen and USA 1932 1000 70 50 20 Buie Buie USA 1960 600 87 56 31 Parks UK 1961 30 73 - -
Lockhart-Mummery UK 1977 - 80 - - and Todd Vasilevsky and Canada 1984 160 59 44 15 Gordon Cirocco and Reilly USA 1992 216 81 51 30
Garcia-Aguilar et al USA 1996 353 83 - - Table 2. Literature Review- The Positive Predictive Value of Goodsall’s Rule PRIMARY (INTERNAL) OPENING LOCATION POSTERIOR ANTERIOR TOTAL Author(s) Country Year Total Number of Number of Number of Number Patients (%) Patients (%) Patients of (%) Patients Cirocco and USA 1992 216 Men 80 (87) Men 36 (57) 156 (72) Reilly Women 31(97) Women 9 (31) All 111(90) All 45 (49)
Barwood et al Australia 1997 107 8 (91) 30 (69) 88 (82)
Coremans et al Belgium 2003 121 Men (90) Men (69) 96 (79) Women (69) Women (75) All 62 (84) All 34 (72) Table 3. Using a Midline Rule vs. Goodsall’s Rule Improved the Positive Predictive Value (ppv) (Cirocco and Reilly)
PRIMARY (INTERNAL) OPENING (Total- 216 patients) POSTERIOR LOCATION ANTERIOR LOCATION (124 patients) (92 patients) Men Women Total Men Women Total
Obey Goodsall’s (n) 80 31 111 36 9 45 Rule (%) (87) (97) (90) (57) (31) (49)
Obey Midline Rule 80 31 111 39 26 65 (n) (87) (97) (90) (62) (90) (71) (%)
BOWEL PREPARATION Colonic Bacteria Mechanical Bowel Preparation (MBP)
▪ Definition: The administration of substances to induce elimination of fecal contents from the entire human colon ▪ Rationale: To decrease/eliminate gross stool from the colon and thereby reduce the microbial burden that may contaminate tissues during surgery ▪ Assumptions: Improves healing of colon anastomoses; decreases leak rates and infections; and improves handling of the colon during surgery Mechanical Bowel Preparation (MBP) ▪ Theoretical Advantages ▪ Decreases bacterial load ▪ Reduces infection ▪ Reduces leaks ▪ Disadvantages ▪ Patient discomfort ▪ Difficult compliance especially for outpatients ▪ Electrolyte imbalances ▪ Volume depletion ▪ Mucosal injury? History of Elective Colon Surgery
▪ Infrequent operation before the 1930s ▪ In late 1930s, interest increased: ▪ Improved Anesthesia ▪ Blood Bank ▪ Improved diagnostics ▪ *Complications: ▪ Mortality rate of 10-12% ▪ 70-90 % rate of surgical site infection (SSI) ▪ High anastomotic leak rates (>20%): staged procedures advocated to avoid leaks
*Poth: World J Surg 1982; 6:153-159 History of Elective Colon Surgery
MBP was employed from the early years and became an established practice by 1930. ▪ Microbiology culture techniques advanced rapidly in the 1930s and the colon was found to have dense bacterial colonization ▪ Fecal contamination of water supplies and poor sanitation were clearly identified as health issues ▪ Colon injury was associated with high death rates from SSI ▪ Unprepared colon difficult to manage at laparotomy History of Elective Colon Surgery
MBP was recognized from the mid-to-late 1930s to NOT reduce the concentration of bacteria in the colon lumen: ▪ Poth EJ. A clean intestinal anastomosis: an experimental study. Arch Surg. 1934;28:1087–1094. ▪ Poth EJ. A clean intestinal anastomosis, II: an experimental study. Arch Surg. 1935;31:579–586. ▪ Poth EJ. Succinylsulfathiazole: an adjuvant in surgery of the large bowel. J Am Med Assoc. 1942;120:265–269. History of Elective Colon Surgery
▪ Advent of antibiotics in 1930s raised hope for improvements in infection rates following colon operations ▪ Two academic factions emerged: ▪ Altemeier: Systemic antibiotics for prevention ▪ Poth: Antimicrobial Intestinal Preparation History of Elective Colon Surgery
Poth and Intestinal Antisepsis
▪ Extensive work with sulfa preparations ▪ Absorption a problem with some preparations; large amounts of drug had to be given over a sustained period of time for an effect ▪ No anaerobic activity ▪ Sulfathalidone emerged as the most likely agent and it was put into use History of Elective Colon Surgery
▪ After WW II, systemic penicillin emerged for the treatment of infection ▪ Considerable promise for systemic drugs for infection prevention in colon surgery ▪ No new developments occurred in the use of oral antibiotics until 1950 with the introduction of Neomycin ▪ Neomycin and Sulfathalidone ▪ Good microbiologic effect in the laboratory ▪ No clinical trials History of Elective Colon Surgery Prevention of Infection 1950s: A “Bummer”
▪ Several clinical trials by Altemeier and others: No benefit for preventive antibiotics in colon surgery and other operations ▪ Staphylococcus aureus enterocolitis reported by Altemeier: Associated this complication with the use of the oral antibiotic bowel preparation ▪ Preventive antibiotics administered either systemically or as an oral bowel preparation appeared to be dead concepts Mechanical Bowel Preparation
“Mechanical preparation by means of purgation and enemas is utilized in nearly all patients undergoing elective operation of the colon. Clinical experience long ago demonstrated that mechanical removal of gross feces from the colon was associated with decreased morbidity and mortality rates in patients undergoing operation of the colon. Controversy today concerns only the addition of antibiotics to preoperative mechanical preparations.”
Nichols et al: Surg Gynecol Obstet 1971; 132:323. Mechanical Bowel Preparation
Nichols RL, Gorbach SL, Condon RE: Alteration of intestinal microflora following preoperative mechanical preparation of the colon.
Dis Colon Rectum 1971; 14:123-7 “However, the concentration of bacteria remaining in the colonic content is not significantly altered by vigorous mechanical cleansing” Prevention of Surgical Site Infection
• Clinical trials failed to show benefit for “preventive” antibiotics • Altemeier’s group demonstrated no value in multiple clinical trials of the 1950s • The timing of administration was not well controlled, and all initiated antibiotics AFTER the procedure. Antibiotic (Tetracylcine) Protection of Colon Anastomosis (in dogs)
Cohn. Ann Surg 1955; 141: 707-13 Colon at Initial Operation
Cohn. Ann Surg 1955; 141: 707-13 Control – Six Dogs Median Survival, 41 hrs
Cohn. Ann Surg 1955; 141: 707-13 Tetracylcine Treated Dog Explored at 9 Days – 6 of 7 Survived
Cohn. Ann Surg 1955; 141: 707-13 Prevention of Surgical Site Infection Use of Preventive Antibiotics: GI Surgery
Cephaloridine Placebo Patients 101 98 Colon Patients 54 50 Infections 6% 29%* Colon Infection 7% 30%*
(Polk and Lopez-Mayor, Surgery 1969; 66:97) (*P<0.01) Preventive Oral Antibiotics for Colon Surgery
SSI/Patients SSI Rate Placebo 27/63 43% Neomycin 28/68 41% Neomycin/ 3/65 5% (P<0.01) Tetracycline
Washington, Judd et al: Ann Surg, October 1974 Preventive Oral Antibiotics for Colon Surgery
SSI/Patients SSI Rate Placebo 21/60 35%
Neomycin/ 5/56 9%* Erythromycin
Clarke et al:Ann Surg 1977;186:251-258
(P<0.05)* Mechanical Bowel Preparation Condon/Nichols Recommendation
▪ 2 Days before operation: ▪ Low residue or liquid diet ▪ Magnesium sulfate 30 ml of 50% solution at 10 AM, 2 PM, and 6 PM ▪ Fleets enema(sodium phosphate) until clear in the evening. ▪ Day before operation: ▪ Admission to hospital ▪ Clear liquids ▪ Magnesium sulfate as above at 10:00 AM and 2 PM Vs whole gut lavage with polyethylene glycol (PEG) ▪ Neomycin and erythromycin 1 gram each po at: 1 PM, 2 PM, and 11 PM (Mayo: 2 gm each at 7 & 11 PM) Preventive Antibiotics in Colon Surgery: What do Surgeons do?
▪ Survey of 471 Colon and Rectal Surgeons in U.S. ▪ 86.5% used Preoperative Oral Antibiotics and Preoperative Parenteral Antibiotics ▪ 11.5% used Parenteral Antibiotics only ▪ 1.1 % used Oral Antibiotics only ▪ 0.9% used no antibiotics
Nichols et al, Clin Infect Dis 1997; 24:609 History of Elective Colon Resection
▪ Late 1990s, bowel preparation fell into disfavor. ▪ Managed care disallowed pre-surgical admission ▪ Patient complaints about bowel preparation ▪ Poor compliance with MBP ▪ Motility issues with home oral erythromycin ▪ Utility of combined MBP + oral antibiotics challenged MBP versus No MBP
WITHOUT Mechanical WITH Mechanical Preparation Preparation
Author No. year No. Patients Infections Patients Infections Miettinen 2000 129 10 138 13
Bucher, 2005 75 6 78 17 Fa-Si-Oen 2005 125 13 125 16
Ram 2005 165 13 164 18
Zmora 2006 129 17 120 15
Jung 2007 657 106 686 103 Contant 2007 684 96 670 90 Pena-Soria 2008 64 11 65 19 Mechanical Bowel Preparation Does It Reduce SSI Rates?
MBP No MBP (PEG)
SSI 10/78 (13%) 5/75 (6%)
Anastomotic Leaks 5/78 (6%) 1/75 (1%)
*(P=0.07); **(P=0.21)
Bucher. Br J Surg. 2005;92:409-414 9.6% vs 8.3%, N.S.
Guenega KKFG, et al: Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD01544. Pub1-3. 4.2% v. 3.4%, N.S.
Guenega KKFG, et al. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD01544. Pub1-3. Mechanical Bowel Preparation
Van't Sant HP et al. Ann Surg. 2010 Jan;251(1):59-63. In Conclusion
o There is Sufficient Evidence to Abandon MBP
o Rare Evidence Demonstrates the Benefit of MBP
o MBP has Been Shown to be Harmful in a Few Studies
o No-MBP will Eventually Become the Standard for CR Surgery
o Parenteral Antibiotics Continue to Have a Defined Role
o Routine Use of Oral Antibiotic Preparation Should be Revisited
J. S. Hourigan, MD University of Kentucky Department of Surgery Grand Rounds April 2010 Preventive Systemic Antibiotics in CRS
▪ Trovafloxacin* vs cefotetan ▪ MBP only ▪ One dose of each preoperatively
Trovafloxacin Cefotetan
SSIs* 39/161 32/156
Infection Rate 24% 21%
Clinically evaluable patients at 30 days postoperative follow up * No longer on the market
Milsom et al. Am J Surg. 1998;176:46S-52S Oral vs Systemic Antibiotics Elective Colon Surgery ▪ All patients received systemic preoperative amikacin and metronidazole ▪ Oral neomycin and metronidazole were randomized
Oral Drugs No Oral Drugs
SSI/Patients 5/109 17/106
Infection Rate 5% 16%
There was no difference in rate of anastomotic (P<0.01) leak or intraabdominal abscess Lewis. Can J Surg. 2002;45:173-180. Preventive Antibiotics in Colon Surgery: Systemic vs. Systemic + Oral Antibiotics
Lewis RT: Can J Surg 2002; 45:173. Preventive Antibiotics in Colon Surgery: Systemic vs. Systemic + Oral Antibiotics
Odds Ratio
95% Confidence Interval
Kaiser et al54 Lau et al56 Coppa et al57 Reynolds et al58 Khubchandani et al59 Stellato et al60 Taylor et al61 McArdle et al62 Lewis et al50 Peto Meta- analysis P< 0.0001 0.0 0.1 1.0 10 1 Odds Ratios (Log10)
Fry D: American Journal of Surgery, 2011 Michigan Surgical Quality Collaborative Oral Antibiotics vs. No Oral Antibiotics
16 month study; n=2011 patients; all received systemic antibiotics
Englesbe et al: Ann Surg 2010; 252:514-520 SURGICAL SITE INFECTION (SSI)
Hendron et al, Ann Surg 2013; 257:469-475. SURGICAL SITE INFECTION (SSI)
Kim et al: Ann Surg 2014; 259:310-314 Oral Antibiotic Colon Preparation
▪ Key Points ▪ Must have a complete and thorough MBP ▪ Which MBP is best is NOT available ▪ MBP must be completed before oral antibiotics are given ▪ Alternative oral antibiotic agents need to be evaluated
Fry et al. Surg Infect. 2005; 6:19-25. C. difficile Infection and Oral Antibiotic Bowel Preparation Probiotics
▪ Should colon surgery patients with MBP plus oral antibiotics have their GI tract recolonized with bacteria following the procedure? ▪ Prospective trials in Europe, little interest in the USA Mechanical Bowel Preparation (MBP) ▪ Theoretical Advantages ▪ Decreases bacterial load ▪ Reduces SSI ▪ Reduces anastomotic leak ▪ Disadvantages ▪ Patient discomfort ▪ Difficult compliance especially for outpatients ▪ Electrolyte imbalances ▪ Volume depletion ▪ Mucosal injury? Elective Colon Surgery Summary
▪ MBP alone does not reduce SSI ▪ Systemic antibiotics WITHOUT MBP & oral antibiotics reduces SSI rate to 16-25% ▪ Systemic antibiotics WITH MBP & oral antibiotics reduces SSI rate to 5-10% and appears to reduce the rate of anastomotic leak BOWEL PREPARATION-TOP 10(Dirty Dozen)REASONS ▪ Decrease SSI ▪ Decrease anastomotic leak ▪ Allows on-table colonoscopy (locate lesion) ▪ Manipulation/handling of hollow viscus ▪ Avoid stool incorporation into staple lines ▪ Avoid stool burden in post-op period (ileus) ▪ Avoid 1st stool to pass of firm consistency ▪ Decreased ‘spill’ from inadvertent enterotomy ▪ Decreased ‘spill’ during resection/anastomosis ▪ Decreased post-op ‘spill’ in case of anastomotic leak ▪ Staged LAR (+ loop) after Neoadjuvant Rx for Rectal CA ▪ Easier to defend if litigation ensues Update on C. difficile colitis Epidemiology
▪ Affects nearly 500,000 Americans every year ▪ 15-30,000 deaths ▪ $4.8 billion in hospitalizations alone ▪ Can be caused by any antibiotic, most commonly clindamycin, fluoroquinolones, penicillins, cephalosporins ▪ Guidelines recommend testing only patients who have new-onset diarrhea with 3 or more unformed stools in 24 hours Current Medication Recommendations ▪ Infectious Diseases Society of America and Society for Healthcare Epidemiology of America - 2018 ▪ Initial episode, non-fulminant – Vancomycin 125 qid x10 days or Fidaxomicin 200 mg bid x 10 days – recent data suggests Metronidazole (Flagyl) clearly inferior to other options ▪ Initial episode, fulminant (hypotension, shock, ileus, megacolon) – Vancomycin 500 po/ng/rectal qid plus Metronidazole 500 IV q 8h ▪ First recurrence – Vancomycin 125 qidx10days if Flagyl used first or Vancomycin taper over 6-10 weeks ▪ Future recurrence – Vancomycin taper, Vancomycin 125 qid x10day followed by Rifaximin 400 tidx20days or Fidaxomicin 200 bidx10days or Fecal Microbial Transplant (FMT) ▪ FMT has the strongest evidence for C. diff recurrence Fecal Microbial Transplantation (FMT) ▪ Form of FMT used in Chinese medicine for over 1700 years for various GI ailments ▪ Eiseman in 1958 used fecal enemas for 4 patients with C diff colitis ▪ Initially performed with directed donor transplants ▪ Open Biome (started at MIT) offers pre-screened, multi-donor, ready to administer stool ▪ Can be administered with colonoscopy, flexible sigmoidoscopy, nasojejunal, nasogastric, gastroscope or pills ▪ Antibiotics stopped 24-48 hours prior to FMT ▪ No stool testing after FMT unless recurrent symptoms Fecal Microbial Transplantation (FMT)
▪ Efficacy in non-randomized studies average 90% (recurrence rates 10%) ▪ Efficacy in randomized studies not as good, but better than other options for multiple recurrences ▪ Current recommendation - consider FMT with 3rd episode ▪ No difference between frozen and fresh FMT ▪ Furaya-Kanamori et al* reported 30 and 90 day failures with UGI/NJ instillation (5.6% and 17.9%) vs. LGI (4.9% and 8.5%) ▪ Postigo et al** - UGI 85.3% success vs. 93.2% LGI success ▪ UGI route is simpler with no patient prep required
▪ *Furaya-Kanamori et al. J Clin Gastroenterol 1996 ** Postigo et al. Infection 2012 “Poop pills”
Kao et al 2016 – 360 ml at colonoscopy vs. 40 pills in RCT – both 96% success rate with single treatment Youngster et al 2016 – 180 patients – 15 tablets on 2 consecutive days – at 8 weeks, 82% cured with single treatment, 2nd treatment for relapse - overall cure rate 91% Emergent FMT
▪ Fischer et al (Gut Microbes: 2017) ▪ 57 consecutive patients with severe disease unresponsive to antimicrobial therapy ▪ FMT protocol – via Colonoscopy/sigmoidoscopy ▪ Pseudomembranes present – Vancomycin 125 po qid x 5 days, repeat FMT if still symptomatic ▪ With symptomatic resolution, Vancomycin x 10 days ▪ Treatment success at 1 month - 91% ▪ Single FMT 52.6%, 2 FMT 28.1%, 3 FMT 7%, 4-5 FMT 3.5% ▪ Overall survival 94.7% at 1 month and 78.6% at 3 months Surgical Recommendations
▪ SUBTOTAL COLECTOMY- MODERATE quality evidence ▪ DIVERTING LOOP ILEOSTOMY- colonic lavage followed by antegrade vancomycin flushes- ONLY LOW QUALITY evidence – initial study decreased mortality from 50% to 19%, colectomy avoided in 93% ▪ Byrn JC, Maun DC et al found vasopressor requirement, mental status changes and treatment length to be significant predictors of mortality ▪ WBC>25 K, rising Lactate >5, preoperative shock, advanced age, intubation, multi-organ failure all associated with high mortality On the Horizon
▪ Antibiotics ▪ Recent failure of 2 antibiotics in phase 3 trials ▪ Ridinilazole – very-narrow spectrum antimicrobial – better sustained response vs. Vancomycin in phase 2 trial ▪ DAV132 – Activated charcoal product decreases antibiotic concentration in the proximal colon without affecting systemic uptake/concentration of antibiotic – entering phase 2 ▪ Vaccines ▪ Sanofi vaccine reached Phase 3, but discontinued in 2017 ▪ Pfizer vaccine also in Phase 3 – contains toxoids of toxin A and B, requires 3 doses ▪ Valneva vaccine successful Phase 2 trial in 2016 Bezlotoxumab
▪ Monoclonal antibody against toxin B ▪ Used in combination with Fidaxomicin to reduce risk for recurrent CDI by 40-50% ▪ Phase 3 trials significantly reduced risk of recurrence in high risk groups ▪ Decreased CDI-associated readmissions from 9.6%-4.0% Conclusion Treatment of C. diff colitis
▪ Challenging disease – becoming more prevalent ▪ Metronidizole removed from antibiotic treatment recommendation ▪ Abdominal colectomy remains surgical standard of care for ‘failing’ patients ▪ FMT continues to show great promise ▪ Medical management - Not much promising on the immediate horizon
KOCK POUCH Nils Kock, October 1967 Contraindications
▪ Small bowel Crohn’s disease
▪ Potential for short gut ▪ 20% small bowel length
▪ Lack of motivation
▪ Patulous bowel
▪ Obesity Continent Ileostomy
▪ S/P remote TPC, ileostomy not acceptable ▪ UC patient needs TPC, not candidate for IPAA ▪ Poor sphincter function ▪ Pelvic fibrosis/Prior pelvic RT ▪ Rectal Cancer ▪ Reach ▪ Failed IPAA, not amenable to redo IPAA due to ▪ Poor sphincter function ▪ Patient disatisfaction ▪ Reach Conversion of Failed Pelvic Pouch to Continent Ileostomy (CI)
▪ 64 patients with failed IPAAs converted to CI (1982-2007) ▪ Median time interval 4.5 years (range 7m-22 years) ▪ Septic IPAA complications - 56% ▪ Existing J pouch used for CI – 25% (16/64 pts)
Lian, Dis Colon Rectum 2009 Conversion of Failed IPAA to Continent Ileostomy
▪ 30-day complication rate - 31% ▪ Long-term complications- 60% ▪ Revision surgery in 29/64 pts (45%) ▪ Majority within 1st year ▪ Median revision-free interval 2.8 years (3 m -19 years) ▪ 61/64 (95%) retained CI at end of study (median follow-up 5 yrs) ▪ Only 1 patient on TPN for short bowel
Lian, Dis Colon Rectum 2009 Conversion of Failed IPAA to Continent Ileostomy ▪ Are outcomes the same as in patients with denovo K pouch?
▪ 67 patients with J to K conversion case-matched ▪ Age, sex, BMI, diagnosis ▪ No difference in K pouch survival rates
Year Failed IPAA (n=11) No IPAA (n=16) % CI (95% lower, 95% upper) % CI (95% lower, 95% upper)
1 92 82-97 94 84-98 5 79 66-88 80 67-89
Aytac, DCR 2017 What about Crohn’s disease?
▪ Crohn’s proctocolitis without small bowel involvement ▪ Analagous to IPAA in Crohn’s disease? Not really….
▪ 48 patients with CD undergoing continent ileostomy ▪ Intentional in 15, delayed diagnosis in 33 (mean 4 years) ▪ Major revisions needed in 83% (fistula, afferent limb and valve strictures) ▪ 50% pouch survival rate (median f/u 19 yrs [1-33])
Aytac, Dis Colon Rectum 2017 Don’t Even Think About It…
▪ Lifetime patients ▪ Reoperations very challenging ▪ High complication rates ▪ Can’t intubate at 5 pm on Friday…
▪ Attracts “difficult” personalities Summary
▪ Continent ileostomy is a rare but viable alternative to conventional ileostomy ▪ Quality of life compares favorably ▪ Patient selection and preoperative counseling are key ▪ Although reoperations are common, patients are likely to retain their CI for the long-term
Continent Ileostomy
▪ Kock (“K”) pouch
▪ Introduced as an improvement over the standard ileostomy ▪ Flush stoma ▪ No appliance ▪ Intubated 3-4 times daily ▪ No nighttime intubation needed Initial Design
▪ 40 cm of terminal ileum
▪ “U” configuration
▪ Corner opened and matured to skin
▪ Poor continence
▪ Coughing
▪ Straining The Nipple Valve
▪ Nipple valve developed c. 1973 ▪ Serosal scarring and suture fixation ▪ Major improvement; added continence ▪ Mechanism relies on rising intra- pouch pressure to close valve
▪ Prone to slippage Modifications to Nipple Valve
▪ Excision of mesenteric fat and peritoneum with valve rotation c. 1977
▪ Stapling with fascial or Marlex mesh strip c. 1978 Kock Series
▪ 314 patients
▪ 1967-1979
▪ Included evolution of techniques for valve fixation
▪ Mortality 2.2%
▪ Reduction in early complications from 23% (1967-74) to 15% (1975-79) Evolution of Valve Design
Technique of nipple valve No. pts. Slippage Prolapse Fistula Revision construction
Suture fixation + 93 41 (44%) 0 9 (9.7%) 54% serosal scarring
Rotation 121 21 (17%) 6 (5%) 13 (11%) 33% procedure
Staples + fascia 32 0 1 0 6% or marlex mesh Valve Continence
Use of No nipple Nipple valve ileostomy valve (n=27) (n=259) appliance always 1 5 occasionally 4 6 never 22 (81.5%) 248 (95.8%) Continent Ileostomy:An Account of 314 Patients Kock, Myrvold, Nilsson, Philipson University of Goteborg, Sweden
“The advantages of the continent ileostomy over a conventional ileostomy have generally been recognized but the complexity of the surgical procedure, implying risks for complications and failures, has been criticized and has restrained to the use of this procedure… …Because of the complexity of the procedure and the demanding postoperative management, the continent ileostomy should preferably be performed only by surgeons experienced in this field and at centers where greater experience with the method can be accumulated.” The Slipped Valve
▪ The “Achilles’ heel”
▪ Symptoms: difficult intubation followed by incontinence to gas and stool
▪ Risk factors: obesity, patulous bowel, weak abdominal wall
▪ Incidence 15-50%
▪ Can occur within months of operation Overcoming Valve Slippage
▪ Promote fibrosis b/w valve layers (formalin, silver nitrate, talc, asbestos, emery paper) (Geroulanos, et al)
▪ Orthopedic rasp (Gelernt, et al)
▪ Deep diathermy (Madigan)
▪ PTFE b/w valve layers (Flake, et al) Long-Term Complications
Complication No. Patients (n=330) Percentage fistula 83 25.2 Parastomal hernia 51 15.5 Valve prolapse 20 6.1 pouchitis 87 26.4 Stoma stricture 33 10 Valve slippage 98 29.7 Cleveland Clinic Series
• Predictors of pouch failure: • Crohn’s disease (HR 4.5) • Female gender (HR 2.4) • Fistula (HR 3.0) • BMI (HR 2.4 per 5 unit increase)
• 10 and 20-year pouch survival rates- 87% and 77% • Average 3 pouch revisions per patient • Median revision-free interval- 14 months
Nessar, et al, DCR 2006 Postoperative Management
▪ 5-7 day hospitalization with frequent irrigation of catheter
▪ Continuous catheter drainage at discharge
▪ Post op visit at 4 weeks with testing of pouch capacity and continence
▪ Intermittent intubation; gradual increase in the interval for next month
▪ Yearly follow up Successful Outcome
▪ Endoscopic appearance correlates to function
▪ 6 cm valve length
▪ Tip fixed to pouch wall
▪ Fully continent
▪ Easy intubation
▪ Emptied 4-5 times daily Slipped Valve
good Not really Continent Ileostomy Salvage
▪ Most common indications are valve slippage and fistulas
▪ Valve ▪ Re-intussusception (early post-op) ▪ 180-degree pouch rotation and neo-valve (late)
▪ Fistula ▪ Depends on location (valve vs. pouch body)
RECTAL CANCER ▪ CA Office of Statewide Health Planning and Development database 2000-2005 ▪ Rectal cancer patients identified by ICD-9 code (154.1) ▪ LAR and APR by CPT code (48.63 and 48.5) ▪ 7187 rectal cancer operations in 321 hospitals ▪ Hospitals classified as Low (≤30), Medium (31-60) , or High (≥60) volume based on number of rectal cancer operations during the study period
Int J Colorectal Dis 2013; 28:191-196 National Cancer Database (NCDB)
▪ Hospital-based cancer registry sponsored by the Commission on Cancer (CoC) & ACS
▪ >1 million case reports yearly from ~1500 CoC-member institutions
▪ Collects data on 70% of all new invasive cancer diagnoses in the U.S. each year NCDB Rectal Cancer Patients 2013
▪ N=21,393
▪ Approximately 50% of annual U.S. rectal cancer cases
▪ Number of hospitals=1327
▪ Approximately 90% of all CoC - accredited hospitals
▪ Range of rectal cancer patients treated: 1 to 286 ▪ Median number of patients per hospital: 27 ENDOSCOPIC FINDINGS
Carlo Ratto (Agostino Gemelli University, Rome, Italy) DG-HAL ADVANTAGES
➢ No tissue resected (less incontinence) ➢ Each step under visual control ➢ No major complications reported REVIEW of LITERATURE*
▪ Meta-analysis of 17 studies ▪ Limited quality of studies ▪ Retrospective ▪ Varying degrees of follow-up ▪ DG- HAL only vs DG-HAL + RAR ▪ Lack of RCTs
*Giordano et al THD: A Systematic Review DCR 2009 REVIEW of LITERATURE*
Total of 1996 patients Grade 2 & 3 hemorrhoids Return to normal activity in 2-3 days Post-operative pain- 18.5% of patients No major complications “Long-term” follow-up ( > 12 months): ▪ 10.8% recurrence of prolapse ▪ 9.7 % recurrence of bleeding ▪ 8.7% recurrence of pain Recurrence rate highest with grade 4 hemorrhoids
*Giordano et al THD: A Systematic Review, DCR 2009 COMPLICATIONS
No major complications have been reported Minor complications are infrequent:
▪ Bleeding ▪ Thrombosis ▪ Pain ▪ Urinary retention ▪ Tenesmus Is Doppler Necessary for DG-HAL?
2 RCTs reveal that DG-HAL (Doppler) vs visual ligation alone did not improve results and may be associated with more postop pain and complications
*Gupta et al; Tech Coloproctol, 2011 *Schuurman et al; Ann Surg, 2012 FUNCTIONAL OUTCOMES*
199 patients underwent DG-HAL Anal manometry performed pre-op and post-op (@ 1,3, and 12 months) No difference pre/post anal rest/squeeze pressure No post-op fecal incontinence ( Wexner Index)
* Walega et al, Surg Endoscopy, 2008 CONCLUSIONS
DG-HAL is best reserved for: ▪ Grade 2 & 3 hemorrhoids ▪ Recurrent symptoms after RBL ▪ Patients who desire early return to work ▪ Patients in whom excision may be detrimental to function (high risk of incontinence) ▪ May repeat or follow with RBL,SH or Hd surgery
RCT- PENG et al* (RBL vs. SH)
Only trial comparing RBL to SH ▪ SH- more pain & minor morbidity ▪ SH- better chance of symptomatic cure ▪ External disease- “evidence suggests that their natural history after SH involves a process of gradual involution”
* Peng et al DCR 2003;46:291-297. RCT- SH vs. CONVENTIONAL
▪ SH less painful ▪ Rate of recurrence higher in SH group 3rd Degree Hemorrhoids- 12% 4th Degree Hemorrhoids- 50%
Ortiz et al BJS 2002;89: 1376-81. META-ANALYSIS OF ‘SH’*
SHORT TERM BENEFITS: ▪ Less pain/analgesic required ▪ Shorter OR time/hosp stay/time off work ▪ Earlier return to ‘normal’ activities
LONG TERM FAILURE: ▪ Increase recurrence- 1 year (5.7% vs. 1%)
* jandra & Chan DCR 2007;50:878-92. MULTICENTER RCT*-SH v. FERGUSON
▪ 1st prospective multicenter RCT in US ▪ All surgeons: Complete a training program Minimum of 10 SH operations ▪ Patient stipends ($50 diary/$25 6 & 12 month visits – Ethicon)
* Senagore et al DCR 2004;47: 1824-1836. STAGE IV HEMORRHOID HEMORRHOID TREATMENT OPTIONS
▪ Stage I- diet,RBL> IRC, ScleroRx, Cryo ▪ Stage II- RBL > IRC, ScleroRx, Cryo ▪ Stage III- RBL, PPH, Doppler-guided, Hd ▪ Stage IV- Hemorrhoidectomy ▪ Acute Crisis-Emergent Hemorrhoidectomy ▪ Acute Thrombosis- Excision based on pain Prevention of Surgical Site Infection
• Alexander Fleming discovered Penicillin in 1929 • Introduction of antibiotics into clinical practice (early 1940s) raised hopes in the treatment of bacterial infection • In surgery, the prospects of using antibiotics for infection prevention was recognized Discovery of Sulfanilamide
▪ Discovered Prontosil in 1931. ▪ Published results in 1935 ▪ Treated patients with streptococcal and staphylococcal infection ▪ Received the Nobel Prize in 1939.
Gerhard Domagk (1895-1964) Oral Antibiotic Bowel Prep Revitalized
• Popularized Kanamycin as an oral aminoglycoside for intestinal antisepsis - 1960s • Abandonment of tetracycline: Staphylococcal resistance •Laboratory evidence of suppression of bacterial concentration in the colon • Antistaphylococcal activity •Data showed benefit of Kanamycin but against historical controls Preventive Oral Antibiotics for Colon Surgery Preventive Systemic Antibiotics Experimental Evidence ▪ Cutaneous injection of bacteria ▪ Inflammation at 24-48 hrs is proportional to the logarithm of the bacterial inoculums.
Mechanical Preparation of the Colon Potential Agents
▪ Enemas ▪ Mechanism of action: distention of colon ▪ Soap Suds, Saline, Sodium phosphate ▪ Require delivery of solution to cecum; 15 minutes of delivery and retention before being expelled. ▪ Technically difficult with only the rectosigmoid being evacuated. ▪ Purgatives ▪ Mechanism: Hyperosmolar catharsis ▪ Magnesium sulfate; Magnesium citrate ▪ Require 48 hours of oral administration to be effective ▪ May still have use in preparation of colons with partial obstruction Mechanical Preparation of the Colon Potential Agents
▪ Stimulants/Irritants ▪ Mechanism: Stimulate colonic smooth muscle contraction ▪ Dulcolax, Castor oil ▪ Do not provide complete preparation ▪ Cramping not well received by patients ▪ Elemental Diets/clear liquids ▪ Mechanism: reduce undigested food residue ▪ Always require use of an additional agent (eg. Enemas) ▪ Mistaken concept: Up to 90% of rectosigmoid stool volume may be exfoliate cells and bacteria Mechanical Preparation of the Colon Potential Agents
Whole Gut Irrigation ▪ Mechanism: Isotonic “flooding” of the colon with large volume of oral administration. ▪ Require delivery of large volume (4 or more liters) in 4-6 hours ▪ Saline: ▪ Inexpensive ▪ Can be delivered by nasogastric tube ▪ Sodium absorption is a problem (ie., hypernatremia in elderly or patients with poor renal failure) ▪ Mannitol: ▪ Sweet flavor well tolerated ▪ Methane gas from bacterial action can be a problem (eg., explosion when using cautery) ▪ Polyethylene glycol/sodium salt solution (Golytely™) PREVENT Trial Outcomes: CE Patients
Ertapenem Cefotetan (n=346)* (n=339) Reason for Failure n % n % Any failure 102 29.5 145 42.8 Surgical site infection 63 18.2 105 31 Unexplained antibiotic use 29 8.4 26 7.7 Anastomotic leak 10 2.9 14 4.1
* P=0.002
Itani et al. N Engl J Med. 2006;355:2640-2651. SURGICAL SITE INFECTION
Deierhoi et al: JACS 2013; 217:763-769. Mechanical Bowel Preparation
Polyethylene Sodium Glycol Phosphate N= 303 367 SSIs 103 (34%) 87 (24%)
P = 0.03 (Univariant analysis) P = 0.065 (Multi-variant analysis)
Itani KM et al: Am J Surg 2007; 193:190 Oral Antibiotics in Colorectal Surgery
Clostridium No Clostridium Incidence difficle Infection difficile Infection
Received Oral 8 99 7.4% Antibiotics
No Oral 5 192 2.6%* Antibiotics
P = 0.03*
Wren SM et al: Arch Surg 2005; 140:752. Mechanical Bowel Preparation
449 Patients Undergoing Low Anterior Resection….
Van't Sant et al. Ann Surg. 2010 Jan;251(1):59-63 RCT of DG-HAL vs. PPH*
Grade 3 / 4 internal hemorrhoids PPH n= 18 vs. DG-HAL n= 23 Patients seen 1,3, and 6 weeks after operation: Primary endpoint- resolution of Sx at 6 weeks ▪ 83% PPH vs. 78% DG-HAL
Secondary endpoint- VAS score on POD#1, 1& 3 weeks ▪ VAS score decreased on POD # 1 and week 1 in DG-HAL group ▪ VAS score equal at 3 weeks ▪ Acute bleeding complications (12% PPH and 4% DG-HAL)
*Festen et al, Int J Colorectal Dis, 2009
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