Cholecystectomy Blunt Dissection

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05366920
• Other study ID #: CHOLECYSTECTOMY BLUNT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2022
• Source: Imam Mohammad ibn Saud Islamic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: February 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• dissection of gallbladder in laparoscopic cholecystectomy
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
• dissection of gallbladder in laparoscopic cholecystectomy
laparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus

Locations

Country	Name	City	State
Saudi Arabia	Central fourth Health Cluster	Hail

Sponsors (1)

Lead Sponsor	Collaborator
Imam Mohammad ibn Saud Islamic University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days for discharge after surgery		30 days
Primary	operative time		30 days
Primary	intraoperative bleeding amount	bleeding which require suction or draining	30 days
Secondary	type of analgesic and dose		30 days
Secondary	number of events of postoperative nausea and vomiting which require anti emetic drug		30 day
Secondary	number of days after surgery when readmission is required		30 days
Secondary	presence of a morbidity	number of days needed for discharge from service	30days