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Clinical Trials/CTRI/2022/10/046920
CTRI/2022/10/046920Not yet recruitingPhase 3

Evaluation Of Anastomotic Leak Risk Calculator in Colonic Surgeries - An Institutional Study

KMC, Manipal1 site in 1 country294 target enrollmentStarted: January 11, 2022Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
294
Locations
1
Primary Endpoint
To look for anastomotic leak 30 days post operatively in colectomy patients

Study Overview

Brief Summary

In Patients who underwent Colonic Resection, the most commonly dreaded complication is the risk of Anastomotic leak. Anastomotic leaks increases the risk of overall post operative mortality and morbidity in patients. The purpose of this study is to see the predictability of a Calculator called the anastomotic leak risk calculator, to predict the outcome of colonic anastomotic surgery. This risk calculator takes into consideration simple variables like gender,  BMI, the use of anticoagulants, serum protein level and incidence of intra operative complications. The risk of AL will be predicted individually by using this calculator. Patients will be followed up for 30 days post operatively to evaluate the predictability of this calculator.

Study Design

Study Type
Observational

Eligibility Criteria

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

Inclusion Criteria

  • Patients who underwent colectomy on emergency or elective basis with or without protective colostomy.

Exclusion Criteria

  • Patients less than 18 years of age 2)Colectomy done in trauma patients 3)Patients with incomplete information.

Outcomes

Primary Outcomes

To look for anastomotic leak 30 days post operatively in colectomy patients

Time Frame: To look for anastomotic leak 30 days post operatively in colectomy patients

Secondary Outcomes

  • To Calculate and Compare Anastomotic Leak Risk Calculator pre operatively and post operatively, considering intraoperative complications as an independent variable(30 days)
  • To evaluate the use of Anastomotic Leak Risk Calculator to decide if a protective stoma is needed in a resection.(30 days)

Investigators

Sponsor
KMC, Manipal
Sponsor Class
Private medical college

Study Sites (1)

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