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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05555810
Other study ID # lclc
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 30, 2023

Study information

Verified date September 2022
Source Assiut University
Contact Morsi Morsi, phd
Phone 00201006727303
Email profmorsy6060@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 30, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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