Risk of Complications from Enterotomy Or Unplanned Bowel Resection During Elective Hernia Repair

ORIGINAL ARTICLE Risk of Complications From Enterotomy or Unplanned Bowel Resection During Elective Hernia Repair

Stephen H. Gray, MD; Catherine C. Vick, MS; Laura A. Graham, MPH; Kelly R. Finan, MD, MSPH; Leigh A. Neumayer, MD, MS; Mary T. Hawn, MD, MPH

Hypothesis: Enterotomy or unplanned bowel resec- 12.6% were recurrent prior suture. Overall, 7.3% had an tion (EBR) may occur during elective incisional hernia EBR. The incidence of EBR was increased in patients with repair (IHR) and significantly affects surgical outcomes prior repair: 5.3% for primary repair, 5.7% for recurrent and hospital resource use. prior suture, and 20.3% for prior mesh repair (PϽ.001). The occurrence of EBR was associated with increased post- Design: Retrospective review of patients undergoing IHR operative complications (31.7% vs 9.5%; PϽ.001), rate between January 1998 and December 2002. of reoperation within 30 days (14.6% vs 3.6%; PϽ.001), and development of enterocutaneous fistula (7.3% vs Setting: Sixteen tertiary care Veterans Affairs medical 0.7%; PϽ.001). After adjusting for procedure type, age, centers. and American Society of Anesthesiologists class, EBR was associated with an increase in median operative time (1.7 Patients: A total of 1124 elective incisional hernia re- to 3.5 hours; PϽ.001) and mean length of stay (4.0 to pairs identified in the National Surgical Quality Improve- Ͻ ment Program data set. 6.0 days; P .001).

Intervention: Elective IHR. Conclusions: Enterotomy or unplanned bowel resection is more likely to complicate recurrent IHR with prior Main Outcome Measures: Thirty-day postoperative mesh. The occurrence of EBR is associated with in- complication rate, return to operating room, length of creased postoperative complications, return to the op- stay, and operative time. erating room, risk of enterocutaneous fistula, length of hospitalization, and operative time. Results: Of the 1124 elective procedures, 74.1% were primary IHR, 13.3% were recurrent prior mesh IHR, and Arch Surg. 2008;143(6):582-586

EOPERATIVE ABDOMINAL nias were repaired in 2003.8 Hernia recur- surgery is complicated by rence after repair occurs in 10% to 53% the frequent presence of in- of patients.9-13 Incisional hernia repair with tra-abdominal adhesions.1-3 prosthetic mesh has been associated with Intestinal adhesions result a decreased recurrence rate in random- Author Affiliations: Deep South inR future bowel obstructions, female in- ized controlled trials; however, it is less Center for Effectiveness fertility, and abdominal pain, and they also likely to be used in the presence of intes- Research, Birmingham Veterans increase the risk of subsequent abdomi- tinal injury.9,10,14 Affairs Medical Center nal surgery.1,4 Postoperative adhesions have Little is known about the incidence of (Drs Gray, Finan, and Hawn been shown to increase operative time and and risk factors for intestinal injury dur- and Mss Vick and Graham), and the conversion rate from laparoscopic to ing IHR. The aim of this study is to de- Department of Surgery 1,5,6 (Drs Gray, Finan, and Hawn open procedures. In addition, exten- scribe the risk factors for and the conse- and Mss Vick and Graham) and sive adhesiolysis increases the risk of in- quences of enterotomy or unplanned bowel Health Services and Outcomes testinal injury.7 resection (EBR) on short-term IHR out- Research Training Program, Incisional hernia repair (IHR) is, by comes. We examine the effect of preopera- Department of Medicine definition, reoperative abdominal sur- tive comorbidities obtained from Na- (Dr Gray), University of gery, and intestinal injury during the her- tional Surgical Quality Improvement Alabama at Birmingham; and Veterans Affairs Medical Center nia repair may affect the type of repair per- Program (NSQIP) data and surgery- and Department of Surgery, formed and ultimate outcome. Incisional specific variables obtained from operative University of Utah, hernia repair is a commonly performed op- note abstraction on the risk of EBR. We spe- Salt Lake City (Dr Neumayer). eration, and approximately 105 000 her- cifically focus on the effect of EBR on elec-

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 tive IHR outcomes, especially postoperative complica- tated operative record. The presence of any full-thickness bowel tions and hospital resource allocation. wall injury recorded in the operative note was considered an enterotomy. The occurrence of a bowel resection documented in the operative record that was not planned before operation METHODS or that was a consequence of an incarcerated hernia was included in this analysis. STUDY DESIGN Independent variables of interest were patient-level demographics (age and sex), preoperative comorbid conditions, tech- This is a retrospective analysis of patients undergoing IHR at 16 nique of repair, history of prior repair, and intraoperative vari- Veterans Affairs (VA) medical centers affiliated with surgical resi- ables. Preoperative risk factors were defined using the NSQIP dency programs across the United States between January 1998 definitions. A dichotomous variable was constructed for tech- and December 2002. Institutional review board approval and nique of repair to classify repairs as either suture or mesh. Type waiver of informed consent was obtained at all participating VA of repair was analyzed on 3 levels: primary repair, recurrent re- medical centers. Eligible procedures were identified by query- pair prior suture, and recurrent repair prior mesh prosthesis. ing the Veterans’ Affairs NSQIP database by Current Procedural The effect of EBR on IHR outcomes was assessed. Dichoto- Terminology (CPT) codes for ventral hernia repair (49560, 49561, mous outcomes of interest were the presence of 1 or more post- 49565, 49566, 49568, 49570, 49572, 49580, 49585, 49587, 49590, operative complications, return to the operating room, and de- and 49659). Individual operative notes were obtained from each velopment of postoperative ECF. The occurrence of ECF was site and were abstracted by physicians to identify type of hernia identified by querying administrative data and was verified by repair, method of repair, intraoperative enterotomy or bowel re- cross-referencing with the medical record. Continuous out- section, and other operative variables. Outcome variables were comes of interest were operative time and postoperative length obtained from the NSQIP, National Patient Care Database, and of hospitalization. the computerized patient record system.

STUDY DATABASES STATISTICAL ANALYSIS Univariate analysis of demographics and operative variables was The NSQIP prospectively collects data from all 123 VA facili- performed to describe the study population. ␹2 Tests were per- ties that perform surgery and includes preoperative, intraop- formed to examine differences in proportions among cases based erative, and postoperative outcome variables. The NSQIP ac- on the presence of EBR. Multivariate logistic regression mod- crues the CPT code and date of procedure for all noncardiac els were used to examine possible predictors of EBR, effect of cases performed in the VA system. Additional risk variables are EBR on postoperative complications, and return to the oper- collected on a subset of patients based on a sampling algo- ating room. Those variables with PՅ.10 in testing of univari- rithm that minimizes bias from high-volume centers and roughly ate association with EBR were used as main effects in logistic includes 70% of all major operations performed.15,16 Thirty- regression analysis. Manual backward elimination was used to day morbidity and mortality data, operative time, and length achieve a best-fit logistic regression model. All statistical tests of stay were obtained from the NSQIP database. were performed using SAS statistical software, version 9.1 (SAS The VA National Patient Care Database is composed of the Institute Inc, Cary, North Carolina). Patient Treatment File (PTF) and the Outpatient Care Files (OPC).17 The PTF is a national VA database that includes all admissions to VA hospitals along with up to 10 International RESULTS Classification of Diseases, Ninth Revision (ICD-9)18 diagnostic and procedure codes. The OPC is a national VA database that The NSQIP query identified 4444 ventral hernia repairs contains information on all ambulatory contacts with VA staff. performed at the 16 VA hospitals between January 1998 The PTF and OPC were queried for the presence of enterocutaneous fistula (ECF) by CPT codes (44120, 44121, 44125, and December 2002. Analysis was limited to patients un- 44130, 44620, 44640, and 44650) and ICD-9 codes (537.4, dergoing elective primary and recurrent IHR. Cases ex- 565.1, 569.60, 569.62, 569.69, and 569.81). cluded from analysis included the following: (1) those with The computerized patient record system is a comprehen- urgent or emergent case status (n=470), (2) cases of um- sive electronic medical record available through Web access. bilical hernia repair (n=1591), (3) cases of primary epi- Medical record abstraction for patients with potential postop- gastric ventral hernia repair (n=217), (4) cases of IHR with erative ECF identified from the PTF and the OPC was per- a same-site concomitant procedure (n=747), and (5) cases formed to confirm whether an ECF was present. with missing NSQIP preoperative risk factor data (n=295). The final study population included 1124 procedures. STUDY POPULATION Of the 1124 procedures available for analysis, 1033 (95.1%) were performed on men. Overall, EBR oc- We identified all patients at the 16 VA hospitals with CPT codes curred in 82 (7.3%) IHRs. The composition of the study noted. Patients were excluded if their repair was urgent or emer- population by type of repair is as follows: primary re- gent, if the repair was not an IHR (ie, umbilical hernia repair or ventral hernia repair), if there was a same-site concomitant pair, 74.1%; recurrent, prior suture repair, 12.6%; and procedure (ie, cholecystectomy or planned colectomy), if their recurrent, prior mesh repair, 13.3%. No differences in pa- operative note was not available for abstraction, or if the case tient age, sex, or the presence of diabetes mellitus were had 1 or more missing NSQIP preoperative risk variables. found between those with and those without EBR (Table 1). Patients with EBR had a higher frequency of STUDY VARIABLES preoperative congestive heart failure and steroid use. A significantly increased incidence of EBR was found The main variable of interest, enterotomy or unplanned bowel during repair of recurrent hernia with prior mesh repair resection (EBR), was defined by the presence of EBR in the dic- (Figure). The number of fascial defects and resident post-

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 Table 1. Summary of the 1124 Patients in the Study 25 Population and the Occurrence of an EBR During Elective Incisional Hernia Repair by Patient Demographics and ∗ Comorbidities 20

Odds Ratio 15 No. of EBR, (95% Confidence P Variable Patients No. (%)a Interval) Value EBR, % 10 Demographics Age, y Ͻ60 548 38 (6.9) 1.1 (0.7-1.7) .70 5 Ն60 576 44 (7.6) Sexb Male 1059 79 (7.5) 0 2.1 (0.5-8.9) .30 Primary Recurrent Prior Recurrent Prior Female 55 2 (3.6) Repair Suture Repair Mesh Repair Racec White 909 61 (6.7) 1.3 (0.7-2.2) .70 Other 206 17 (8.3) Figure. Incidence of enterotomy or bowel resection (EBR) by type of hernia Ͻ Preoperative risk factors repair. * P .001 vs the other types of repair. Smoking Yes 409 37 (9.1) 1.5 (0.9-2.3) .10 No 715 45 (6.3) Table 2. Occurrence of an EBR During Elective Alcohol use Incisional Hernia Repair by Procedural Characteristics Yes 102 8 (7.8) 1.1 (0.5-2.3) .80 No 1022 74 (7.2) No. of EBR, CHF Patients No. (%) P Value Yes 13 4 (30.8) 5.9 (1.8-19.5) .001 No 1111 78 (7.0) Repair history Diabetes mellitus Primary 825 44 (5.3) Yes 153 13 (8.5) Recurrent 140 8 (5.7) Ͻ.001 1.2 (0.7-2.3) .50 No 971 69 (7.1) Prior mesh repair 148 30 (20.3) a COPD No. of defects Yes 142 12 (8.5) Single defect 673 49 (7.3) 1.2 (0.6-2.3) .60 .60 No 982 69 (7.1) Multiple defects 418 27 (6.5) Steroid use Resident postgraduate year Yes 33 8 (24.2) 1-2 285 17 (6.0) 4.4 (1.9-10.1) Ͻ.001 .30 No 1091 74 (6.8) Ն3 839 65 (7.8) b ASA class Type of repair 1-2 426 25 (5.9) Open suture 334 26 (7.8) 1.4 (0.9-2.3) .20 Ն3 698 57 (8.2) Laparoscopic 114 9 (7.9) .90 Open mesh 675 47 (7.0) Abbreviations: ASA, American Society of Anesthesiologists; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; EBR, Abbreviations: See Table 1. enterotomy or bowel resection. a Number of defects was missing for 33 procedures. a A total of 82 of the 1124 patients (7.3%) had an EBR. b Type of repair was missing for 1 procedure. b Sex data were missing for 10 procedures. c Race data were missing for 10 procedures. turn to the operating room (12/82 [14.6%] vs 38/1042 [3.6%]; OR, 4.5; 95% CI, 2.3-9.1; PϽ.001). The devel- graduate year were not associated with EBR occurrence opment of ECF after EBR was also more frequent than (Table 2). In multivariate logistic regression analysis in procedures without EBR (6/82 [7.3%] vs 7/1042 [0.7%]; of predictors of EBR, previous repair with mesh (odds OR, 11.7; 95% CI, 3.8-35.6; PϽ.001). The median time ratio [OR], 5.0; 95% confidence interval [CI], 3.0-8.3) for ECF to develop was 27.5 months (range, 0.3-83.4 and long-term steroid use (OR, 6.2; 95% CI, 2.6-14.8) months) postoperatively and was similar between pa- were independently associated with EBR, whereas con- tients with and without EBR. gestive heart failure was not. Univariate analysis of patients experiencing an EBR No postoperative 30-day mortality occurred in the found that they had longer operative times and lengths of study group. Patients undergoing procedures in which stay. The median (interquartile range) operative time was EBR occurred were more likely to develop 1 or more post- 3.48 (2.48-4.62) and 1.33 (1.08-2.50) hours in the EBR operative complications at 30 days (26/82 [31.7%] vs 99/ and no EBR groups, respectively (PϽ.001). The median 1042 [9.5%]; OR, 4.4; 95% CI, 2.7-7.4; PϽ.001). Post- (interquartile range) postoperative length of stay was 6 (4- operative complications among patients with EBR 10) and 4 (2-6) days in the EBR and no EBR groups, re- included wound infection or dehiscence (n=15), uri- spectively (PϽ.001). The occurrence of EBR was associ- nary tract infection (n=3), failure to wean from ventila- ated with increased operative time (1.6 hours; PϽ.001) tor (n=3), renal insufficiency (n=2), systemic sepsis in multivariate linear regression modeling, adjusting for (n=2), and deep vein thrombosis (n=1). The occur- age, recurrent repair, repair technique, and American So- rence of EBR was associated with an increased rate of re- ciety of Anesthesiologists (ASA) class. Similar results for

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 tive surgery. Our finding that long-term steroid use in- Table 3. Logistic Regression Models of Morbidity creased the risk of EBR is novel. Other studies have found After Elective Incisional Hernia Repair an increased risk of overall morbidity after hernia repair but did not associate it with intraoperative bowel in- Odds Ratio (95% 28 Model Confidence Interval) jury. One potential explanation is that long-term steroid use may affect the tissue quality of the intestine and Ն 1: Development of 1 postoperative predispose those patients to intestinal injury. This, how- complications Enterotomy or bowel resection 3.8 (2.2-6.6) ever, has yet to be substantiated in the literature. How- Steroid use 2.8 (1.2-6.3) ever, based on these findings, we recommend consider- ASA class Ն3 1.6 (1.0-2.4) ation of prophylactic bowel preparation before elective 2: Patient return to the operating room surgery on these high-risk populations. Enterotomy or bowel resection 4.9 (2.4-9.9) Prior studies7,29 have identified EBR as a predictor of Ն ASA class 3 2.3 (1.1-4.8) development of any postoperative complication, need for reoperation, increased operative time, and increased post- Abbreviations: See Table 1. operative length of stay using univariate analyses. We found that the occurrence of EBR was the strongest predictor of the development of any postoperative compli- multivariate linear regression modeling of postoperative cation or the need for subsequent operation in multivar- length of stay found an increase of 3.2 days (PϽ.001) af- iate models. We were also able to show in adjusted models ter an EBR, adjusting for age, recurrent repair, postopera- that the occurrence of EBR was associated with longer tive complication, repair technique, and ASA class. operative time and postoperative length of stay. The oc- Best-fit logistic regression models of postoperative com- currence of EBR has long-term effects as evidenced by plications and return to the operating room after IHR dem- increased incidence of ECF formation. Additional stud- onstrated that the occurrence of EBR was the strongest ies to determine the effect of EBR on hernia recurrence predictor of postoperative complications and was asso- are under way. It has previously been shown that mesh ciated with a greater than 4-fold increase in return to the implantation rates are decreased in the setting of EBR, operating room (Table 3). and mesh seems to be the key factor associated with decreased recurrence.9,10,14 COMMENT Our study has several limitations. Our study population primarily consists of older white men, limiting the gen- We found that EBR occurred in 7.3% of elective IHRs in eralizability of our findings. In addition, information bias a large cohort of patients from 16 VA medical centers. may exist because of differing quality of individual opera- The incidence of EBR was highest in recurrent hernia re- tive notes and use of administrative data. This incidence pair after prior mesh placement. The occurrence of an of EBR is likely understated because we captured only those EBR was associated with increased complication and sub- cases that were identified intraoperatively and dictated in sequent operation rates at 30 days. Furthermore, EBR was the operative note. The development of ECF was ascer- associated with a significantly increased risk of ECF for- tained from administrative data and likely underesti- mation in the follow-up period. mates the true incidence. Finally, our finding of in- Our finding of a 7.3% incidence of EBR is consistent creased risk of EBR in recurrent repair with prior mesh with the literature, in which rates of bowel injury dur- may not apply to nonadhesive mesh products available.30 ing laparoscopic and open ventral hernia repair range from Our results demonstrate that patients with prior IHR 7.2% to 9%.19 Prior studies6,20 have reported that most with mesh and long-term steroid use are at significantly bowel injuries occurred during procedures complicated increased risk for EBR during elective IHR. The occur- by the presence of multiple adhesions or prior abdomi- rence of EBR is a significant predictor of increased pa- nal surgery. A study21 that reported a 1.2% incidence of tient morbidity and subsequent ECF formation and is as- intestinal injury during laparoscopic IHR attributed the sociated with increased hospital resource allocation. low incidence to the advantages of pneumoperitoneum Additional studies on the long-term effects of EBR on IHR and visualization during laparoscopic adhesiolysis. We recurrence rates need to be performed. did not observe this in our study, and the low rate of EBR associated with laparoscopic IHR in previous studies could Accepted for Publication: March 20, 2007. represent case selection. Correspondence: Mary T. Hawn, MD, MPH, University We found that prior hernia repair with mesh pros- of Alabama at Birmingham, 1530 3rd Ave S, KB 429, Bir- thesis and long-term steroid use were independent pre- mingham, AL 35294 ([email protected]). dictors of EBR occurrence. The increased incidence of Author Contributions: Dr Hawn had full access to all of EBR seen in recurrent hernia repair with prior pros- the data in the study and takes responsibility for the integ- thetic mesh implantation is not surprising because the rity of the data and the accuracy of the data analysis. Study presence of foreign material is known to increase adhe- concept and design: Gray, Neumayer, and Hawn. Acquisi- sion formation.2,22-27 Most prior mesh repairs in this study tion of data: Gray, Vick, Finan, and Neumayer. Analysis and were performed with polypropylene mesh. Future stud- interpretation of data: Gray, Vick, Graham, Neumayer, and ies will need to be performed to determine if the newer Hawn. Drafting of the manuscript: Gray, Vick, and Hawn. mesh products aimed at reducing adhesion formation re- Critical revision of the manuscript for important intellectual sult in fewer bowel injuries during subsequent opera- content: Graham, Finan, Neumayer, and Hawn. Statistical

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 analysis: Gray, Vick, Graham, Finan, and Neumayer. Ob- 12. Flum DR, Horvath K, Koepsell T. Have outcomes of incisional hernia repair im- tained funding: Neumayer and Hawn. Administrative, tech- proved with time? a population-based analysis. Ann Surg. 2003;237(1): 129-135. nical, and material support: Vick, Graham, and Hawn. Study 13. Raftopoulos I, Vanuno D, Khorsand J, Kouraklis G, Lasky P. Comparison of open supervision: Neumayer and Hawn. and laparoscopic prosthetic repair of large ventral hernias. JSLS. 2003;7(3): Financial Disclosure: None reported. 227-232. Funding/Support: This study was supported by the Health 14. Finan KR, Vick CC, Kiefe CI, Neumayer L, Hawn MT. Predictors of wound infec- Services Research and Development Program of the De- tion in ventral hernia repair. Am J Surg. 2005;190(5):676-681. 15. Khuri SF, Daley J, Henderson W, et al. The Department of Veterans Affairs’ NS- partment of Veterans Affairs Office of Research and De- QIP: the first national, validated, outcome-based, risk-adjusted, and peer- velopment and grant 5 T32 HS013852 from the Agency controlled program for the measurement and enhancement of the quality of sur- for Healthcare Research and Quality. gical care: National VA Surgical Quality Improvement Program. Ann Surg. 1998; Disclaimer: The views expressed herein are not necessar- 228(4):491-507. 16. Khuri SF, Daley J, Henderson WG. The comparative assessment and improve- ily those of the Veterans Administration Central Office or ment of quality of surgical care in the Department of Veterans Affairs. Arch Surg. the National Surgical Quality Improvement Program. 2002;137(1):20-27. Additional Contributions: We gratefully acknowledge 17. Murphy PA, Cowper DC, Seppala G, Stroupe KT, Hynes DM. 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