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Estimating the accuracy of a calculator developed to predict anastomotic leaks in colonic surgeries

Phase 3
Not yet recruiting
Conditions
Other intraoperative and postprocedural complications and disorders of digestive system,
Registration Number
CTRI/2022/10/046920
Lead Sponsor
KMC, Manipal
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
294
Inclusion Criteria

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

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To look for anastomotic leak 30 days post operatively in colectomy patientsTo look for anastomotic leak 30 days post operatively in colectomy patients
Secondary Outcome Measures
NameTimeMethod
To evaluate the use of Anastomotic Leak Risk Calculator to decide if a protective stoma is needed in a resection.30 days
To Calculate and Compare Anastomotic Leak Risk Calculator pre operatively and post operatively, considering intraoperative complications as an independent variable30 days

Trial Locations

Locations (1)

Kasturba Hospital

🇮🇳

Udupi, KARNATAKA, India

Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Varsha Chinta
Principal investigator
9849922233
varsha.chinta1@learner.manipal.edu

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