| CTRI Number |
CTRI/2026/04/109504 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients undergoing keyhole gallbladder removal surgery to compare gallbladder removal using a specimen bag versus direct removal, and its effect on bile spillage and wound infection. |
|
Scientific Title of Study
|
Effect of endobag assisted versus conventional gallbladder extraction on bile spillage and port site surgical site infection during laparoscopic cholecystectomy: A randomized controlled trial in a gallbladder cancer endemic region |
| 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 Vipan Kumar |
| Designation |
Assistant Professor, Surgical Gastroenterology |
| Affiliation |
Indira Gandhi Medical College Shimla, HP - 171001 |
| Address |
Department of Surgery, Indira Gandhi Medical College, Shimla, Himachal Pradesh - 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
918628828284 |
| Fax |
|
| Email |
kumardrvipan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipan Kumar |
| Designation |
Assistant Professor, Surgical Gastroenterology |
| Affiliation |
Indira Gandhi Medical College Shimla, HP - 171001 |
| Address |
Department of Surgery, Indira Gandhi Medical College, Shimla, Himachal Pradesh - 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
918628828284 |
| Fax |
|
| Email |
kumardrvipan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipan Kumar |
| Designation |
Assistant Professor, Surgical Gastroenterology |
| Affiliation |
Indira Gandhi Medical College Shimla, HP - 171001 |
| Address |
Department of Surgery, Indira Gandhi Medical College, Shimla, Himachal Pradesh - 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
918628828284 |
| Fax |
|
| Email |
kumardrvipan@gmail.com |
|
|
Source of Monetary or Material Support
|
| IIndian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, India – 110029. Funding application has been submitted to the Indian Council of Medical Research (ICMR), New Delhi; however, no funding has been sanctioned at present. |
| Multidisciplinary Research Unit (MRU), Indira Gandhi Medical College, Shimla, Himachal Pradesh, India – 171001. Funding application has been submitted to the Indian Council of Medical Research (ICMR), New Delhi; however, no funding has been sanctioned at present. |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, India – 110029. Funding application has been submitted to the Indian Council of Medical Research (ICMR), New Delhi; however, no funding has been sanctioned at present. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vipan Kumar |
Indira Gandhi Medical College, Shimla |
Department of Surgery, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India, 171001
Shimla
HIMACHAL PRADESH |
918628828284
kumardrvipan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee, Indira Gandhi Medical College, Shimla, H.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K851||Biliary acute pancreatitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional gallbladder extraction |
Gallbladder extraction is performed without the use of an endobag through the same standardised port after laparoscopic cholecystectomy. Direct extraction is done under vision as per standard surgical practice.
|
| Intervention |
Endobag-assisted gallbladder extraction |
Gallbladder extraction is performed using a sterile endobag through a standardized port — epigastric or umbilical as per protocol — after completion of laparoscopic cholecystectomy. The gallbladder is placed inside the endobag under direct vision and retrieved, minimizing bile spillage and contamination. The intervention is a single intraoperative procedural step performed only during the index laparoscopic cholecystectomy. Total duration of the intervention is approximately 5–10 minutes, from endobag deployment to complete gallbladder extraction. There is no postoperative continuation of the intervention. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 80 years undergoing elective laparoscopic cholecystectomy for symptomatic gallstone disease who are willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with suspected or proven gallbladder malignancy on preoperative evaluation, emergency cholecystectomy, conversion to open cholecystectomy before gallbladder extraction, pregnancy, or refusal to provide informed consent.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of intraoperative bile spillage occurring specifically during the gallbladder extraction phase of laparoscopic cholecystectomy and incidence of port site surgical site infection. |
Incidence of intraoperative bile spillage occurring specifically during the gallbladder extraction phase of laparoscopic cholecystectomy, assessed intraoperatively during the index surgery from initiation of gallbladder extraction to complete specimen removal; and incidence of port-site surgical site infection, assessed postoperatively on day 7, day 15, and day 30, with final assessment at postoperative day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Positivity of gallbladder bile culture (infected bile)
|
Intra operative |
| 2. Incidence of intra abdominal collection or abscess related to bile leak. |
Within 30 days after surgery. |
| 3. Requirement for fascial extension of the extraction port. |
During surgery. |
| 4. Incidence of early port site hernia. |
Six to twelve months after surgery.
|
Incidence of port site surgical site infection as per CDC criteria
|
Time Point: Within 30 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="1040"
Sample Size from India="1040"
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)
|
08/08/2026 |
| 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="3"
Months="0"
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
|
Gallbladder cancer is endemic in the northern regions of India and incidental gallbladder carcinoma is occasionally detected after laparoscopic cholecystectomy performed for gallstone disease. Bile spillage during gallbladder extraction may increase the risk of port site infection and may have implications for oncological safety in endemic regions.
This prospective randomized controlled trial aims to compare endobag assisted gallbladder extraction with conventional gallbladder extraction during laparoscopic cholecystectomy. The primary outcomes are the incidence of bile spillage occurring specifically during the gallbladder extraction phase and the incidence of port site surgical site infection within thirty days after surgery.
Adult patients undergoing elective laparoscopic cholecystectomy for gallstone disease will be randomized into two groups. In the intervention group gallbladder extraction will be performed using a sterile endobag, while in the comparator group extraction will be performed without an endobag. Secondary outcomes include bile culture positivity, intra abdominal collections related to bile leak, requirement for fascial extension of the extraction port, early port site hernia, and incidence of incidental gallbladder carcinoma on histopathology.
The study is conducted at a tertiary care teaching hospital in a gallbladder cancer endemic region of India with a planned total sample size of one thousand forty participants.
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