Comparison of the Safety of Absorbable and Hem-o-lok Clips in Laparoscopic Cholecystectomy

August 27, 2025 updated by: Ulas Aday

Clinical Outcomes of Absorbable or Hem-o-lok Clip Closure of the Cystic Stump in Laparoscopic Cholecystectomy: a Prospective Randomised Clinical Trial

Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective randomised controlled clinical study; closure of the cystic duct in laparoscopic cholecystectomy will be performed by two different methods. Early clinical results and long-term effects on neighbouring anatomical structures will be investigated.

Study Type

Interventional

Enrollment (Actual)

120

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

  • Turkey (Türkiye)
    • Kartal
      • Istanbul, Kartal, Turkey (Türkiye), 34000
        • Kartal Koşuyolu Higher Specialization Training and Research Hospital

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • elective laparoscopic cholecystectomy ASA I-III Patients who accepted the study

Exclusion Criteria:

  • open surgery emergency cholecystectomy refuse to trial

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
Active Comparator: Single absorbable
Cystic duct to be closed with absorbable single clip
Other: Surgycal procedure
surgical technique
Active Comparator: Single Hem-o-lok
Cystic duct to be closed with Hem-o-lok single clip
Other: Surgycal procedure
surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.
Time Frame: first 30 day
Is it safe to close the cystic stump with a single (haem-o-lok or absorbable) clip?
first 30 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The costs of the clips used
Time Frame: one week
The costs of the clips used will be determined in dollars using Student's t-test.
one week

Collaborators and Investigators

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

Sponsor

Ulas Aday

Investigators

  • Principal Investigator: Mustafa Duman, Kartal Kosuyolu

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)

June 15, 2024

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

August 27, 2025

Study Registration Dates

First Submitted

April 14, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dicle University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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