Dr. Y. Suresh Baba

THESIS SYNOPSIS

DR. Y. SURESH BABA POSTGRDUATE STUDENT DEPARTMENT OF GENERAL SURGERY

K.S HEGDE MEDICAL ACADEMY DERALAKATTE, MANGALORE - 575018 Mangalore.

October -2007

Dr. Y. Suresh Baba,

Postgraduate resident,

Department of General Surgery,

K.S. Hegde Medical Academy.

The secretary,

Institution Ethics Committee,

K.S. Hegde Medical Academy.

Respected sir,

Subject: Regarding ethical clearance for my thesis.

I, Dr. Y. Suresh Baba will be doing dissertation as part of my postgraduate course in General surgery, the topic being ‘Comparative study of early enteral feeding Vs delayed enteral feeding after gastrointestinal surgery’. I shall be grateful if you will grant me the ethical clearance for my study and oblige.

Thanking you,

Yours truly,

Dr. Y. Suresh Baba. Rajiv Gandhi University of Health Sciences,

Karnataka, Bangalore Proforma for registration of subjects for dissertation

1. Name of the candidate and address Dr. Y. Suresh Baba Postgraduate resident Department of General surgery K.S. Hegde Medical Academy Deralakatte, Mangalore Karnataka, 575018.

2. Name of the institution K.S. Hegde Medical Academy Deralakatte, Mangalore-575018.

3. Course of study and subject M.S. General Surgery

4. Year of joining the course 31-05-2007

5. Title of the topic "A comparative study of early enteral feeding Vs delayed enteral feeding, after gastrointestinal surgery”. 6. Brief resume of intended work 6.1 Need for the study

Oral feeding is usually offered following surgery of the gastrointestinal tract when clinical signs of normal intestinal motility are present. This has been the belief for centuries and is being followed without evidence. However, many studies have shown that early oral feeding is well tolerated and is beneficial rather being harmful. It has been tested and proved by several studies that early enteral feeding of patients undergoing surgery of the digestive tract is neither going to increase the incidence or duration of paralytic ileus , nor increase the post operative complications like wound infection or anastomotic leak. Rather it has been shown that early feeding is beneficial with respect to wound healing and nutritional status of the patient. Hence this is an effort to study the impact of early enteral feeding on paralytic ileus and post operative complications in patients undergoing surgery of the gastrointestinal tract . 6.2 Review of literature

Aiko S et al1 showed beneficial effects (immunological competence and suppression of excessive inflammatory response) of immediate enteral nutrition after esophageal cancer surgery.

Braga M et al2 Showed that feeding gut early after surgery is safe and well tolerated and it should represented the first choice for nutritional support in these type of patients.

Gianotti L et al3 Studied on artificial nutrition after pancreotico duodenectomy, stated that early post operative enteral feeding may safely and effectively replace parenteral nutrition in patients undergoing pancreticoduodenectomies.

Han-Geurts JM et al4 showed that early resumption of oral intake does not diminish the duration of post-operative ileus or lead to a significantly increased rate of naso- gastric reinsertion. Tolerance of oral diet is not influenced by gastrointestinal recovery as there is no reason to withhold oral intake following open colo-rectal or abdominal vascular surgery. Post-operative management should include early resumption of diet.

Lewis SJ et al5 done comparative study of early enteral feeding versus nil by mouth after gastro intestinal surgeries. He stated that it may be beneficial.

Petrelli NJ et al6 showed that early oral feeding is safe and feasible for post colectomy patients with history of colo rectal neoplasms.

Repin VN et al7 Showed that enteral tube feeding permits to improve stomach and duodenal surgeries and to reduce cost of treatment. He presented disorders in 1716 patients after gastrectomy and surgeries for chronic duodenal obstruction.

D B A Silk8 comparative study of early enteral feeding versus nil by mouth after gastro intestinal surgery. He has shown that early feeding is beneficial. 6.3 Objectives of the study

1. To study the impact of early feeding on the onset and duration of paralytic ileus, after surgery on digestive tract.

2. To Study the effect of early enteral feeding on anastomotic leak after digestive tract surgery.

3. To study the effect of early enteral feeding on wound infection. 7. Materials and methods 7.1 Source of data.

All patients undergoing elective surgery of the gastrointestinal tract, such as oesophagectomy, gastrectomy, pancreatectomy, appendisectomy, common bile duct exploration at K. S. Hegde Charitable Hospital, within the period of June 2007 to June 2010 will be included in this study.

Inclusion criteria

Consent of the patient for the surgery as well as the study.

All patients undergoing elective surgery of the gastrointestinal tract, such as oesophagectomy, gastrectomy, pancreatectomy, appendisectomy, common bile duct exploration are included.

Patients who had either oral or tube feeding wll be included.

Exclusion criteria

1. Children less than 12 years. 2. Patients operated for peritonitis. 7.2 Methodology

100 patients undergoing elective surgery of the GI tract will be randomized into two groups, for early feeding after surgery and feeding after resumption of bowel sounds.

They will be monitored for tolerance of oral feeding, onset & duration of ileus, Anastamotic leak & wound infection.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly? No.

7.4 Has ethical clearance been obtained from your institution? yes 8. Bibliography

1 Aiko S, Yoshizumi Y, Sugiura Y, Matsuyama T, Naito Y, Matsuzaki J et al, Beneficial effects of immediate enteral nutrition after esophageal cancer surgery. Surg Today 2001;31(11):971-8.

2 Braga M, Gianotti L, Gentilini O, Liotta S, Di Carlo V. Feeding the gut early after digestive surgery: results of a nine-year experience. Clin Nutr 2002 Feb;21(1):59-65.

3 Gianotti L, Braga M, Gentilini O, Balzano G, Zerbi A, Di Carlo V. Artificial nutrition after pancreaticoduodenectomy2000 Nov;21(4):344-51.

4 Han-Geurts J.M, Hop W.C.J, Kok N.F.M, Lim A, Brouwer K.J & Jeekel J. Randomized clinical trails of the impact of early enteral feeding on post-operative ileus & recovery. BJS 2007; 94:555-61.

5 Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta-analysis of controlled trials. BMJ 2001 Oct 6;323(7316):773-6.

6 Petrelli NJ, Cheng C, Driscoll D, Rodriguez-Bigas MA. Early postoperative oral feeding after colectomy: an analysis of factors that may predict failure. Ann Surg Oncol 2001 Dec;8(10):796-800.

7 Repin VN, Tkachenko IM, Gudkov OS, Repin MV Enteral tube feeding early after surgery on the stomach and the duodenum. Khirurgiia (Mosk) 2002:(12):21-5

8 Silk D.B.A , Menzies Gow N. Postoperative starvation after gastrointestinal surgery Early feeding is beneficial. BMJ 2001 October 6; 323(7316): 761–62. 9. Signature of the candidate:

10. Remarks of the guide:

11. Name and designation of the guide: DR.SUBHAKAR BANDARI ASSOCIATE PROFESSOR KSHEMA MANGALORE.

11.1 Signature of the guide:

12. Co-guide:

12.1. Signature of co-guide:

13. Head of the department: DR(COL)A.K.CHATURVEDI. PROFESSOR & HOD. KSHEMA. MANGALORE.

13.1 Signature of the head of the department:

14. Remarks of chairman and principal:

14.1 Signature:

PROFORMA FOR CASE SHEET

Topic –comparitive study of early enteral feeding vs late enteral feeding.\

Name : hospital :

Age : I.P. no :

Sex: date of admission :

Address : date of discharge :

Clinical presentation : pain abdomen

Nausea and vomiting

Mass abdomen

Distention of abdomen.

Constipation

Bleeding per rectum

Diagnosis

Operative findings Anaesthesia—spinal/epidural / general anesthesia

Feeding ----early or late.

Complications : anastamotic leak

Wound infection

Paralytic ileus

Tolerance of oral feeding Patient informed consent form

Study title: A comparative study of early enteral feeding Vs delayed enteral feeding after gastrointestinal surgery.

I ………………………….. declare that I have been briefed and here by consent to be included as a subject in the following dissertation “A comparative study of early enteral feeding Vs delayed enteral feeding after gastrointestinal surgery”

I have been informed to my satisfaction by the attending Dr. Y. Suresh Baba , the purpose of work done and laboratory investigations required and any other investigations that may be required in management of my case

This has been explained to me in the language I understand and I fully consent for the same

Signature of the doctor: Signature of patient:

Name of doctor: