Cholecystectomy Blunt Dissection

Sponsor
Imam Mohammad ibn Saud Islamic University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05366920
Collaborator
(none)
20
1
2
9.1
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
  • 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

Study Results

No Results Posted as of May 9, 2022