Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy

Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy . " A Prospective Comparative Study"

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy

Detailed Description

cholecystectomy is the second most commonly intra-abdominal operation worldwide after Appendectomy. In standard surgery ,there are increase incidence of wound infection,bleeding , discomfort and hospital stay so laparoscopic surgery has become the best choice for treatment of symptomatic and uncomplicated Gall bladder stones and hernia repair.

Once laparoscopic cholecystectomy emerged controversies persist with regard to the best method to ligate the cystic duct and artery. They may be ligated by separate and multiple ligatures by absorbable suture material, or using absorbable clips.

Suture ligation of cystic duct appeared to be more cost effective.On the other hand, the application of clips shown to have some drawbacks such as dislodgement and bile leakage and increase liability of long term clip migration which resulted in biliary stone formation or bile duct stenosis and also they are expensive .Another complication of clips that they may ulcerated through the duodenum.

Ligation takes more time than applying a clip, and it needs well training, but it is feasible, cost- effective and safe alternative method to secure cystic duct and artery in laparoscopic cholecystectomy.

The Aim of this study is to compare the two different methods; Tie versus clipping, for securing cystic duct and artery in laparoscopic cholecystectomy. In terms of efficacy and safety, and also the difference in the times of operations in both methods

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morsi Morsi, phd; Phone Number: 00201006727303; Email: profmorsy6060@gmail.com
• Study Contact Backup: Name: Mostafa Ibrahem, MD; Phone Number: 00201095295794; Email: Mostafamahmoud5622@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Suture ligation of cystic duct and artery; 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; 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 .
ACTIVE_COMPARATOR: Application of clips; 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; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2023
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (ACTUAL): September 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: lclc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No