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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05555810
Collaborator
(none)
50
2
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 .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 .
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy . " A Prospective Comparative Study"
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

  1. safety and efficiency of closure of cystic duct and artery after cutting them during laparoscopic cholecystectomy [one month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Mohamed Korany, PHD, Assut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Gamal Sayed, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05555810
Other Study ID Numbers:
  • lclc
First Posted:
Sep 27, 2022
Last Update Posted:
Sep 27, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 27, 2022