"Comparison of Clip-Based and Clipless Laparoscopic Gallbladder Surgery in Controlling Bleeding"

NCT07517783 | Completed

• 1 other identifier: WMC/ERC/IRB/117
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial compared titanium clips and LigaSure (a vessel sealing device) for controlling bleeding during laparoscopic gallbladder surgery. A total of 114 patients were divided into two equal groups, with one group receiving clips and the other treated using LigaSure. The study found that LigaSure significantly reduced intraoperative blood loss and the time required to achieve hemostasis compared to clips, while overall operative time remained similar in both groups. No major complications were observed. The results suggest that LigaSure provides more efficient and reliable bleeding control, likely due to its advanced mechanism of sealing blood vessels. Although clips remain widely used, LigaSure may be a better option, especially in difficult surgical cases. Overall, the study concludes that LigaSure is a safe and effective alternative to titanium clips with superior hemostatic outcomes in laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy Surgery

Keywords

Laparoscopic cholecystectomy, LigaSure

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss

  The study primarily aimed to compare how much patients bleed during surgery and how fast bleeding is controlled using titanium clips versus LigaSure.

  From surgical incision to completion of surgery

Secondary Outcomes (2)

• time to achieve hemostasis

  From onset of cystic artery bleeding to complete cessation of bleeding during surgery

• operative time

  From surgical incision to completion of surgery

Study Arms (2)

group A: clips

EXPERIMENTAL

Group A is the control arm where patients have the cystic artery sealed with titanium clips during laparoscopic gallbladder surgery, and their bleeding and time to achieve hemostasis are measured for comparison.

Device: clips

group B: ligasure

EXPERIMENTAL

Group B is the intervention arm where patients have the cystic artery sealed using LigaSure, and their bleeding and time to achieve hemostasis are measured for comparison with the conventional clip group.

Device: ligasure

Interventions

clips DEVICE

in group A titanium clips are used to seal the cystic artery

group A: clips

ligasure DEVICE

in group B, ligasure high energy vessel sealing device is used to seal cystic artery

group B: ligasure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fully consented patients aged 18 to 60 years
• With any indication of laparoscopic cholecystectomy

You may not qualify if:

• Who need conversion to open cholecystectomy per-operatively
• With bleeding diathesis (inherited or acquired bleeding disorders)
• Who need concomitant complicated procedure during surgery (e.g., Whipple procedure, or stoma formation)

Sponsors & Collaborators

• Wah Medical college , POF hospital: lead

Study Sites (1)

Wah Medical College, POF Hospital Wah cantt

Wāh, Punjab Province, 47040, Pakistan

Location

MeSH Terms

Interventions

Surgical Instruments

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study was conducted as a single-blinded randomized controlled trial. In this design, the outcome assessor (observer) was blinded to the group allocation, while the operating surgeon was aware of the intervention being performed. Blinding was achieved by ensuring that the trained observer responsible for recording intraoperative outcomes, including blood loss and time to achieve hemostasis, did not know whether titanium clips or LigaSure was used during the procedure. This helped to minimize observer bias in outcome measurement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, parallel-group randomized controlled trial (RCT) designed to compare two different techniques for achieving hemostasis during laparoscopic cholecystectomy.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 8, 2026
• Study Start: January 1, 2024
• Primary Completion: May 28, 2024
• Study Completion: June 30, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year after publication of article in journal

Locations

PA (1)