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

NCT ID: NCT06470360

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-08-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single absorbable

Cystic duct to be closed with absorbable single clip

Group Type ACTIVE_COMPARATOR

Surgycal procedure

Intervention Type OTHER

surgical technique

Single Hem-o-lok

Cystic duct to be closed with Hem-o-lok single clip

Group Type ACTIVE_COMPARATOR

Surgycal procedure

Intervention Type OTHER

surgical technique

Interventions

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Surgycal procedure

surgical technique

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* open surgery emergency cholecystectomy refuse to trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulas Aday

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ulas Aday

Ass. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mustafa Duman

Role: PRINCIPAL_INVESTIGATOR

Kartal Kosuyolu

Locations

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Kartal Koşuyolu Higher Specialization Training and Research Hospital

Istanbul, Kartal, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Dicle University

Identifier Type: -

Identifier Source: org_study_id

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