Improvised Endobag vs Direct Gallbladder Extraction in Laparoscopic Cholecystectomy

NCT07823803 | Recruiting DMC

• 1 other identifier: RIHS/IRB/63/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiasis; Cholecystectomy, Laparoscopic

Outcome Measures

Primary Outcomes (5)

• Surgical Time

  This will be the time in minutes measured Peri-procedurally from skin incision to skin closure

• Visible perforation of the gallbladder developed during gallbladder removal

  Perioperative/Periprocedural

• Visible spillage of bile from the gallbladder during gallbladder removal

  Perioperative/Periprocedural (at the time of gallbladder removal)

• Visible spillage of gallstones from the gallbladder during gallbladder removal

  Perioperative/Periprocedural

• Port site pain

  It will be assessed using Visual Analog scale at 24 hours post procedure

Study Arms (2)

Group Endobag

ACTIVE COMPARATOR

Device: Endobag

Group Control

PLACEBO COMPARATOR

Device: placebo group

Interventions

Endobag DEVICE

Gallbladder will be removed using Endobag

Group Endobag

placebo group DEVICE

Gallbladder will be removed without using Endobag during Laparoscopic Cholecystectomy

Group Control

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective Laparoscopic Cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Rawal Institute of Health Sciences Islamabad: lead

Study Sites (1)

Rawal Institute of Health Sciences

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (1)

• Elangovan S, Naathan KVS, Sivamarieswaran R, Jose MR. Direct Gallbladder Extraction versus Endobag Extraction during Laparoscopic Cholecystectomy: A Prospective Observational Study. J Clin Diagn Res. 2025;19(8):PC12-PC5.

  BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Sadia Principal Investigator, MBBS

CONTACT

+92-318-5190442; sadiaali603@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 16, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)