| CTRI Number |
CTRI/2024/02/063347 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study to find out advantage and disadvantage of putting drain in the cases of gall bladder stone surgery |
|
Scientific Title of Study
|
Post-operative comparison of Laparoscopic cholecystectomy cases with and without drain:A randomized control study at SMS Hospital Jaipur |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupen Songra |
| Designation |
senior professor |
| Affiliation |
SMS medical college jaipur |
| Address |
department of general surgery first floor SMS medical college and hospital tonk road jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928598686 |
| Fax |
|
| Email |
songrabhupen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupen Songra |
| Designation |
senior professor |
| Affiliation |
SMS medical college jaipur |
| Address |
department of general surgery first floor SMS medical college and hospital tonk road jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928598686 |
| Fax |
|
| Email |
songrabhupen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surendra Purohit |
| Designation |
Junior Resident |
| Affiliation |
SMS medical college,Jaipur |
| Address |
Department of General Surgery First floor SMS Medical College and Hospital Tonk road Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461680169 |
| Fax |
|
| Email |
sure.pure09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery SMS Medical College Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of General Surgery |
| Address |
First floor SMS Medical College and Hospital Jaipur |
| 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 Bhupen Songra |
SMS Hospital |
Department of General Surgery First Floor Room number-118 SMS Hospital Jaipur
Jaipur
RAJASTHAN |
9928598686
songrabhupen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not placement of drain |
evaluate merits and demerits of non-drainage in patients undergoing laparoscopic cholecystectomy in the sense of hospital stay and post operative complications in the form of abdominal pain shoulder pain wound infection fever nausea vomiting and hemorrhage |
| Intervention |
placement of drain |
evaluate merits and demerits of placement of drainage in patients undergoing laparoscopic cholecystectomy in the sense of hospital stay and postoperative complications in the form of abdominal pain shoulder pain drain site infection wound infection fever nausea vomiting and hemorrhage |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
all patients undergoing elective laparoscopic cholecystectomy between age group 18-75 year |
|
| ExclusionCriteria |
| Details |
choledocholithiasis
carcinima GB
previous abdominal surgeries
peritonitis
bleeding disorders
cirrhosis
pregnancy
intraop biliary tract injury
conversion to open surgery
performance of any additional procedure
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
duration of surgery
duration of postoperative hospital stay |
60min
1day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| characteristics considered during fpllow up include drain site infection |
1 week and 2nd week visit |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we Compare the effect of Drain use on outcome of Laparoscopic Cholecystectomy in order to study the length of Hospital stay and the Incidence of post operative Morbidity in terms of Complications for evaluation of merits and demerits of Drainage over Non-drainage technique
|