NCT05555810

Brief Summary

The investigators will compare between clipping and ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy. This is the main question that will be discussed in the review.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

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

September 17, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 17, 2022

Last Update Submit

September 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • safety and efficiency of closure of cystic duct and artery after cutting them during laparoscopic cholecystectomy

    The investigators will seek to know the incidence of postoperative complications of laparoscopic cholecystectomy (as signs of biliary leakage as pain, jaundice and raised serum bilirubin level and follow up the drain inserted after doing laparoscopic cholecystectomy) then the investigators will make a comparison between incidence of these complication after closure of cystic duct and artery either by clipping or ligation by sutures. The investigators will try to know rate of advantages disadvantages of each technique also do our best to make strategies for improving efficiency and safety.

    one month

Study Arms (2)

Suture ligation of cystic duct and artery

ACTIVE COMPARATOR

The investigators will ligate cystic duct and artery by traditional sutures during laparoscopic cholecystectomy .

Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy

Application of clips

ACTIVE COMPARATOR

The investigators will put a clips on the cystic duct and artery during laparoscopic cholecystectomy.

Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy

Interventions

The investigators will make a comparison between clipping and ligation of cystic duct and cystic artery during Laparoscopic cholecystectomy and trying to know advantages and disadvantages of each technique .

Application of clipsSuture ligation of cystic duct and artery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with cholecystitis admitted at Assuit University Hospital and planed for lap. cholecystectomy the period of the study

You may not qualify if:

  • Any case not candidate for laparoscopic cholecystectomy and we must do it by open technique .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • van Dijk AH, van Roessel S, de Reuver PR, Boerma D, Boermeester MA, Donkervoort SC. Systematic review of cystic duct closure techniques in relation to prevention of bile duct leakage after laparoscopic cholecystectomy. World J Gastrointest Surg. 2018 Sep 27;10(6):57-69. doi: 10.4240/wjgs.v10.i6.57.

    PMID: 30283606BACKGROUND
  • Singal R, Sharma A, Zaman M. The Safety and Efficacy of Clipless versus Conventional Laparoscopic Cholecystectomy - our Experience in an Indian Rural Center. Maedica (Bucur). 2018 Mar;13(1):34-43.

    PMID: 29868139BACKGROUND

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Mohamed Korany, PHD

    Assut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The investigators will secure Cystic duct and artery with traditional sutures(ligation) in a group. In the another group the cystic duct and artery will be put a clips .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 27, 2022

Study Start

June 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 30, 2023

Last Updated

September 27, 2022

Record last verified: 2022-09