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Clinical Trials/CTRI/2018/01/011064
CTRI/2018/01/011064CompletedNot Applicable

Ileocolic Anastomotic Leaks - An Institutional Study

Kasturba Medical College Manipal1 site in 1 country140 target enrollmentStarted: December 14, 2016Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
140
Locations
1
Primary Endpoint
The objective is to investigate any association between the variables considered and the occurrence of Anastomotic Leak.

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

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.

Outcomes

Primary Outcomes

The objective is to investigate any association between the variables considered and the occurrence of Anastomotic Leak.

Time Frame: The occurrence of leak within 30 days of the surgery

Age

Time Frame: The occurrence of leak within 30 days of the surgery

Preoperative Albumin

Time Frame: The occurrence of leak within 30 days of the surgery

Coexisting illness

Time Frame: The occurrence of leak within 30 days of the surgery

Indication for surgery

Time Frame: The occurrence of leak within 30 days of the surgery

Experience of the surgeon

Time Frame: The occurrence of leak within 30 days of the surgery

Duration of surgery

Time Frame: The occurrence of leak within 30 days of the surgery

Mode of diagnosis of leak

Time Frame: The occurrence of leak within 30 days of the surgery

Nature of surgery

Time Frame: The occurrence of leak within 30 days of the surgery

Preoperative bowel preparation

Time Frame: The occurrence of leak within 30 days of the surgery

Technique of anastomosis

Time Frame: The occurrence of leak within 30 days of the surgery

Management of leak

Time Frame: The occurrence of leak within 30 days of the surgery

Type of anastomosis

Time Frame: The occurrence of leak within 30 days of the surgery

Intraoperative complications

Time Frame: The occurrence of leak within 30 days of the surgery

Time of diagnosis of leak after surgery

Time Frame: The occurrence of leak within 30 days of the surgery

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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