Retrieval of Gallbladder by Improvised Endobag Versus Direct Extraction in Laparoscopic Cholecystectomy
| Registry | NCT07823803 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 120 (Estimated) |
| Sponsor | Rawal Institute of Health Sciences Islamabad (Other) |
| Conditions | Cholecystectomy, Laparoscopic, Cholelithiasis |
| Interventions | Endobag, placebo group (Device) |
| Dates | start 2026-08-30, primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2026-09-16, last updated 2026-09-16 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Cholecystectomy, Laparoscopic All trials for Cholelithiasis All trials of Endobag All trials of placebo group
Eligigble patients will be enrolled after obtaining informed consent. Basic information such as age, gender, body weight, smoking and alcohol history, number of gallstones, and gallbladder characteristics will be recorded.
During surgery, the method used to remove the gallbladder, the port used for extraction, and the duration of surgery will be documented. Any gallbladder perforation, leakage of bile, or spillage of gallstones during the procedure will also be recorded.
After surgery, patients will be monitored in the hospital for 24 hours. Their pain will be assessed before discharge. Patients will then be followed in the outpatient clinic for 10 days to assess wound healing and identify any wound infection or other complications.
The study aims to compare the safety and effectiveness of an improvised retrieval bag with removal of the gallbladder without a retrieval bag during laparoscopic surgery.
Eligible patients undergoing laparoscopic cholecystectomy will be enrolled after obtaining written informed consent. Baseline demographic and clinical characteristics, including age, gender, body mass index, smoking and alcohol history, hypertension, number of gallstones, and gallbladder wall thickness, will be recorded.
Patients will be randomly allocated to receive one of the predefined gallbladder extraction techniques. The port site used for gallbladder retrieval and total operative time will be documented. Intraoperative events, including gallbladder perforation, bile spillage, and stone spillage, will be recorded according to predefined operational definitions.
All procedures will be performed under general anesthesia by the same surgical team. Wound closure will be performed by the researcher using a standardized technique to minimize procedural variability and potential bias.
Following surgery, patients will be monitored in the postoperative ward for 24 hours. Postoperative pain will be assessed using a standardized pain score before discharge. Patients will subsequently be followed in the outpatient department for 10 days, during which the surgical wound will be assessed for infection and other relevant postoperative complications.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group Endobag | Active comparator | Device: Endobag | |
| Group Control | Placebo comparator | Device: placebo group |
Sex: All, ages: 20 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria: * Elective Laparoscopic Cholecystectomy Exclusion Criteria: * Patients having common bile duct stones or dilatation * Acute cholecystitis, gallbladder perforation, malignancy (on medical record). * Patients requiring conversion to open cholecystectomy, ASA III-IV * Patients with skin diseases near wound site, diabetes (HbA1c>6.5%), and Hb <10gm/dl
| Facility | City | Country | Status |
|---|---|---|---|
| Rawal Institute of Health Sciences | Islamabad, Federal | Pakistan | Recruiting |