| CTRI Number |
CTRI/2021/10/037289 [Registered on: 13/10/2021] Trial Registered Prospectively |
| Last Modified On: |
13/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of wound complications in obese patients v/s non-obese patients undergoing emergency abdominal surgery |
|
Scientific Title of Study
|
Comparative study of wound complications in obese patients v/s non-obese patients undergoing first emergency abdominal surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhender kumar |
| Designation |
Second year resident |
| Affiliation |
Government medical college , bhavnagar |
| Address |
Department of general surgery ,
New opd building , 2nd floor,
sir T hospital, bhavnagar , Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
8866698669 |
| Fax |
|
| Email |
akhender.kumar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Firdaus A Dekhaiya |
| Designation |
Associate Professor |
| Affiliation |
Government medical college , bhavnagar |
| Address |
departent of surgery,
2nd floor , new opd building,
Sir T hospital, bhavnagar, gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
09825133976 |
| Fax |
|
| Email |
drfirdausd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhender kumar |
| Designation |
Second year resident |
| Affiliation |
Government medical college , bhavnagar |
| Address |
Department of general surgery ,
New opd building , 2nd floor,
sir T hospital, bhavnagar , Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
8866698669 |
| Fax |
|
| Email |
akhender.kumar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general surgery,GMC bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of general surgery |
| Address |
Government medical college,bhavnagar |
| Type of Sponsor |
Government 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 akhender kumar |
Sir t hospital |
Surgery department, 2nd floor, new opd building, sir t hospital
Bhavnagar
GUJARAT |
8866698669
akhender.kumar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical college, bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clean and clean-contaminated , first abdominal emergency surgeries |
|
| ExclusionCriteria |
| Details |
Re-exploratory surgeries |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare if wound complications of first emergency abdominal surgeries are more in obese than non-obese patients |
post operative day 3,5,7,15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish role of additional factors like immunosuppression and hypoproteinemia in causing wound complications |
Day 0,3,5,7,15 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2021 |
| 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="0"
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
|
To establish role of obesity in causing wound complications after first emergency abdominal surgeries of clean and clean contaminated types |