A single hospital study on the occurrence of leaks between anastomosis of small and large bowel.

Completed

• Conditions: Any disease condition requiring surgery in the form of ileocolic anastomosis

• Registration Number: CTRI/2018/01/011064
• Lead Sponsor: Kasturba Medical College Manipal

Brief Summary

Anastomotic leak is the most feared complication following intestinal resection with incidence varying between 1.8%1 and 15.9%. Anastomotic leakage is associated with the need for re-operation, prolonged hospital stay and increased morbidity and mortality. Controversy surrounds the list of risk factors associated with Anastomotic Leaks with preoperative Serum Protein concentration being found to be an independent risk factor. The influence of surgeon factors over the occurrence of anastomotic leaks has found little evidence. Multiple reoperations and stoma creation are often necessary to control the leak, which significantly increases health risks and health care costs. Hence knowledge about risk factors predisposing patients to Anastomotic Leak will be helpful in early detection and management of an otherwise fatal complication.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-14
• Study Completion: 2018-01-31
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Colectomy (radical/limited) with Ileocolic Anastomosis End ileostomy reversal with Ileocolic Anastomosis.

Exclusion Criteria

Patients who underwent Ileocolic Anastomosis elsewhere and were referred to Kasturba Hospital with Anastomotic Leak Patients with Ileocolic Anastomosis with Diversion Loop Ileostomy Patients with Ileorectal Anastomosis Patients with Ileal pouch Anal Anastomosis Age below 18 years.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective is to investigate any association between the variables considered and the occurrence of Anastomotic Leak.	The occurrence of leak within 30 days of the surgery
Age	The occurrence of leak within 30 days of the surgery
Coexisting illness	The occurrence of leak within 30 days of the surgery
Preoperative Albumin	The occurrence of leak within 30 days of the surgery
Indication for surgery	The occurrence of leak within 30 days of the surgery
Experience of the surgeon	The occurrence of leak within 30 days of the surgery
Duration of surgery	The occurrence of leak within 30 days of the surgery
Mode of diagnosis of leak	The occurrence of leak within 30 days of the surgery
Nature of surgery	The occurrence of leak within 30 days of the surgery
Preoperative bowel preparation	The occurrence of leak within 30 days of the surgery
Technique of anastomosis	The occurrence of leak within 30 days of the surgery
Management of leak	The occurrence of leak within 30 days of the surgery
Type of anastomosis	The occurrence of leak within 30 days of the surgery
Intraoperative complications	The occurrence of leak within 30 days of the surgery
Time of diagnosis of leak after surgery	The occurrence of leak within 30 days of the surgery

Secondary Outcome Measures

Name	Time	Method
To analyze how anastomotic leaks affect hospital stay	Hospital stay is measured in terms of total number of days the patient was admitted in the hospital

Trial Locations

Locations (1)

Kasturba Hospital, Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital, Manipal

🇮🇳Udupi, KARNATAKA, India

Dr Krishna Kalyan Reddy Janumpalli

Principal investigator

8105135208

kalyanreddy@outlook.com