Clinical trial NCT05555810: Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy
Official title: Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy . " A Prospective Comparative Study"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 .
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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 .

Primary outcomes:
measure: safety and efficiency of closure of cystic duct and artery after cutting them during laparoscopic cholecystectomy
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assut University
name: Mohamed Korany, PHD
role: STUDY_DIRECTOR
References:
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.
citation: 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.