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

April 3, 2026 updated by: Wah Medical college , POF hospital

Comparison of Conventional Laparoscopic Cholecystectomy With Clips and Laparoscopic Cholecystectomy Using LigaSure (High Energy Vessel Sealing Devices) Without Clips in Terms of Hemostasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial was conducted to compare the effectiveness of titanium clips and LigaSure, an advanced bipolar vessel sealing device, in achieving hemostasis during laparoscopic cholecystectomy. A total of 114 patients undergoing elective laparoscopic gallbladder surgery were enrolled and randomly assigned into two equal groups. In Group A, the cystic artery was ligated using conventional titanium clips, while in Group B, vessel sealing was performed using the LigaSure device without the use of clips. This study specifically focused on key intraoperative outcomes, including blood loss and the time required to achieve complete hemostasis.

The findings of the study demonstrated that patients in the LigaSure group experienced significantly lower intraoperative blood loss compared to those in the clip group. In addition, the time required to achieve hemostasis was markedly shorter in the LigaSure group, indicating faster and more efficient control of bleeding. Despite these advantages, the total operative time remained comparable between the two groups, suggesting that the use of LigaSure does not prolong the surgical procedure. Importantly, no major intraoperative or postoperative complications were reported in either group, confirming the safety of both techniques.

The improved performance of LigaSure in achieving hemostasis can be attributed to its mechanism of action, which involves the application of controlled bipolar energy to seal blood vessels by denaturing collagen and elastin within the vessel walls. This results in a permanent and reliable seal, minimizing the risk of bleeding. In contrast, titanium clips rely on mechanical occlusion, which may be associated with potential issues such as clip slippage or displacement, particularly in difficult surgical conditions.

These results suggest that LigaSure provides more efficient and consistent hemostatic control compared to conventional clips. This advantage is particularly relevant in complex cases, such as acute inflammation or dense adhesions, where precise and secure vessel sealing is crucial. Although titanium clips continue to be widely used due to their low cost and accessibility, LigaSure may offer superior outcomes in selected patients.

In conclusion, this study establishes that LigaSure is a safe, effective, and reliable alternative to titanium clips for cystic artery control in laparoscopic cholecystectomy. Its use is associated with reduced intraoperative blood loss and faster achievement of hemostasis, making it a valuable tool for improving surgical efficiency and patient outcomes.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Wāh, Punjab Province, Pakistan, 47040
        • Wah Medical College, POF Hospital Wah cantt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Fully consented patients aged 18 to 60 years

    • With any indication of laparoscopic cholecystectomy

Exclusion Criteria:

  • • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A: clips
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
in group A titanium clips are used to seal the cystic artery
Experimental: group B: ligasure
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
in group B, ligasure high energy vessel sealing device is used to seal cystic artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: From surgical incision to completion of surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to achieve hemostasis
Time Frame: From onset of cystic artery bleeding to complete cessation of bleeding during surgery
this study compares how much intraoperative time of surgery required to control bleeding and achieve hemostasis with titanium clips vs using ligasure
From onset of cystic artery bleeding to complete cessation of bleeding during surgery
operative time
Time Frame: From surgical incision to completion of surgery
this study compares duration of surgery using titanium clips vs using ligasure
From surgical incision to completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wah Medical college , POF hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 28, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMC/ERC/IRB/117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

1 year after publication of article in journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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