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

NCT ID: NCT05555810

Last Updated: 2022-09-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 .
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suture ligation of cystic duct and artery

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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 clips

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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 .

Interventions

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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 .

Intervention Type PROCEDURE

Eligibility Criteria

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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 .
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Gamal Sayed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Korany, PHD

Role: STUDY_DIRECTOR

Assut University

Central Contacts

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Morsi Morsi, phd

Role: CONTACT

00201006727303

Mostafa Ibrahem, MD

Role: CONTACT

00201095295794

References

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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.

Reference Type BACKGROUND
PMID: 30283606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29868139 (View on PubMed)

Other Identifiers

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lclc

Identifier Type: -

Identifier Source: org_study_id

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