Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook

Not Applicable

Completed

• Conditions: Cholecystolithiasis
• Interventions: Procedure: dissection of gallbladder in laparoscopic cholecystectomy

• Registration Number: NCT01553331
• Lead Sponsor: Central Finland Hospital District

Brief Summary

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

Detailed Description

After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-10
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasonic dissection	dissection of gallbladder in laparoscopic cholecystectomy	Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus
conventional diathermy hook	dissection of gallbladder in laparoscopic cholecystectomy	Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle

Primary Outcome Measures

Name	Time	Method
operative time	30 days
intraoperative complications	30 days
same day discharge	30 days

Secondary Outcome Measures

Name	Time	Method
analgetic use	30 days
postoperative nausea and vomiting	30 days
readmission	30 days
morbidity	30 days

Trial Locations

Locations (1)

Jyvaskyla Central Hospital; 🇫🇮 Jyvaskyla, Finland