Cholecystectomy Blunt Dissection

• Sponsor: Imam Mohammad ibn Saud Islamic University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05366920
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. 5mm suction irrigation blunt dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with 5mm suction irrigation blunt dissection technique a better same day discharge and a shorter operative time can be achieved.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Cholecystectomy	Procedure: dissection of gallbladder in laparoscopic cholecystectomy; Procedure: dissection of gallbladder in laparoscopic cholecystectomy	N/A

Detailed Description

After initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: conventional diathermy hook Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy	Procedure: dissection of gallbladder in laparoscopic cholecystectomy; Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot; Procedure: dissection of gallbladder in laparoscopic cholecystectomy; laparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus
Active Comparator: 5 mm suction irrigation blunt dissection Laparoscopic cholecystectomy made with 5mm suction irrigation blunt dissection starting from gallbladder fundus Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy	Procedure: dissection of gallbladder in laparoscopic cholecystectomy; Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot; Procedure: dissection of gallbladder in laparoscopic cholecystectomy; laparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus

Outcome Measures

Primary Outcome Measures

1. number of days for discharge after surgery [30 days]

2. operative time [30 days]

3. intraoperative bleeding amount [30 days]

   bleeding which require suction or draining

Secondary Outcome Measures

1. type of analgesic and dose [30 days]

2. number of events of postoperative nausea and vomiting which require anti emetic drug [30 day]

3. number of days after surgery when readmission is required [30 days]

4. presence of a morbidity [30days]

   number of days needed for discharge from service

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA I-II

• BMI under 35

• normal liver enzymes

• no bile duct dilatation in ultrasound

• cholecystolithiasis

Exclusion Criteria:

• NSAID allergy

• previous upper gi-surgery

• common bile duct stones in preoperative imaging

• history of severe acute pancreatitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central fourth Health Cluster	Hail		Saudi Arabia

Sponsors and Collaborators

• Imam Mohammad ibn Saud Islamic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mohammad bukhetan alharbi, associate professor, Imam Mohammad ibn Saud Islamic University
• ClinicalTrials.gov Identifier: NCT05366920
• Other Study ID Numbers: CHOLECYSTECTOMY BLUNT
• First Posted: May 9, 2022
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by mohammad bukhetan alharbi, associate professor, Imam Mohammad ibn Saud Islamic University: Cholecystolithiasis; Cholelithiasis; Gallstones; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical

Study Results

No Results Posted as of May 9, 2022