| CTRI Number |
CTRI/2022/10/046920 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Estimating the accuracy of a calculator developed to predict anastomotic leaks in colonic surgeries |
|
Scientific Title of Study
|
Evaluation Of Anastomotic Leak Risk Calculator in Colonic Surgeries - An Institutional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha Chinta |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
3rd floor, Department of General Surgery, Smt Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9849922233 |
| Fax |
|
| Email |
varsha.chinta1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Badareesh L |
| Designation |
Professor and Head of Unit |
| Affiliation |
KMC, Manipal |
| Address |
3rd floor, Department of General Surgery, Smt Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8861038876 |
| Fax |
|
| Email |
badareesh.l@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Steffi Dcruz |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
3rd floor, Department of General Surgery, Smt Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
steffi.dcruz@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
KMC, Manipal |
| Address |
Kasturba Medical College and Hospital, Manipal, Udupi, 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varsha Chinta |
Kasturba Hospital |
3rd floor, Smt Sharada Madhav Pai, OPD building, Kasturba Medical College and Hospital, Madhav Nagar, Manipal, Udupi, 576104
Udupi
KARNATAKA |
9849922233
varsha.chinta1@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who underwent colectomy on emergency or elective basis with or without protective colostomy |
|
| ExclusionCriteria |
| Details |
1) Patients less than 18 years of age 2)Colectomy done in trauma patients 3)Patients with incomplete information |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for anastomotic leak 30 days post operatively in colectomy patients |
To look for anastomotic leak 30 days post operatively in colectomy patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 variable |
30 days |
|
|
Target Sample Size
|
Total Sample Size="294"
Sample Size from India="294"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |