| CTRI Number |
CTRI/2025/03/082791 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
An Efficient Reusable Instrument for retrieving Gall bladder specimen following Laparoscopic Gall bladder Surgery |
|
Scientific Title of Study
|
An Innovation of an Efficient Endobag for retrieving Gall Bladder specimen in Laparoscopic Cholecystectomy |
| 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.Sinduja S |
| Designation |
Post Graduate , department of general surgery |
| Affiliation |
saveetha medical college |
| Address |
second floor, department of general surgery, saveetha medical college and hospital, saveetha nagar, thandalam, chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7397307710 |
| Fax |
|
| Email |
sindusaravanan0405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P.B.SUDARSHAN |
| Designation |
PROFESSOR , DEPT OF GENERAL SURGERY |
| Affiliation |
saveetha medical college |
| Address |
saveetha medical college and hospital, saveetha nagar, thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9789859925 |
| Fax |
|
| Email |
pbsudarshan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Sinduja S |
| Designation |
postgraduate , dept of general surgery |
| Affiliation |
saveetha medical college and hospital |
| Address |
second floor, department of general surgery ,saveetha medical college hospital, saveetha nagar, thandalam, chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7397307710 |
| Fax |
|
| Email |
sindusaravanan0405@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAVEETHA MEDICAL COLLEGE AND HOSPITAL, SAVEETHA NAGAR, THANDALAM, CHENNAI 602105 |
|
|
Primary Sponsor
|
| Name |
DrSindujaS |
| Address |
Saveetha medical college hospital,saveetha nagar, thandalam, chennai- 602105 |
| Type of Sponsor |
Other [SELF] |
|
|
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 sinduja |
saveetha medical college |
second floor, dept of general surgery, saveetha medical college and hospital, THANDALAM , CHENNAI
Chennai
TAMIL NADU |
7397307710
sindusaravanan0405@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAVEETHA MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
existing methods of gallbladder retrieval |
without the use of special instrument for a period of 6 months |
| Intervention |
novel endobag |
The innovation of a novel endobag for retrieving specimen in laparoscopic cholecystectomy and To reduce the difficulty in retrieval of specimen in minimal access surgeries for a period 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient diagnosed with cholecystitis due to calculous and acalculous gall bladder
patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
patients less than 18 years
patients undergoing open cholecystectomy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
reduces the spillage rate
reduces the port site infection |
day 0. day 3, day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to increase the rate of laparoscopic cholecystectomy |
4 weeks |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 use a disposable sterile endobag with a reusable attachment for extraction of gall bladder. the objective is to increase the practice safe laparoscopic cholecystectomy and to reduce the difficulty in retrieval of the specimens. it is a prospective observational study with a sample size of 50 conducted in saveetha medical college and hospital. the study population includes patients undergoing laparoscopic cholecystectomy. |