NCT06470360

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

April 14, 2024

Last Update Submit

August 27, 2025

Conditions

Laparoscopic Cholecystectomy

Keywords

laparoscopic cholecystectomycystic duct closuresafety

Outcome Measures

Primary Outcomes (1)

  • Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.

    Is it safe to close the cystic stump with a single (haem-o-lok or absorbable) clip?

    first 30 day

Secondary Outcomes (1)

  • The costs of the clips used

    one week

Study Arms (2)

Single absorbable

ACTIVE COMPARATOR

Cystic duct to be closed with absorbable single clip

Other: Surgycal procedure

Single Hem-o-lok

ACTIVE COMPARATOR

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

Other: Surgycal procedure

Interventions

Surgycal procedureOTHER

surgical technique

Single Hem-o-lokSingle absorbable

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • open surgery emergency cholecystectomy refuse to trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Koşuyolu Higher Specialization Training and Research Hospital

Istanbul, Kartal, 34000, Turkey (Türkiye)

Location

Study Officials

  • Mustafa Duman

    Kartal Kosuyolu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

April 14, 2024

First Posted

June 24, 2024

Study Start

June 15, 2024

Primary Completion

June 15, 2025

Study Completion

August 27, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)