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

Cholecystolithiasis Clinical Trial

Official title:

Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553331
• Other study ID #: KSSHPB10208
• Status: Completed
• Phase: N/A
• First received: March 10, 2012
• Last updated: December 10, 2014
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Central Finland Hospital District
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

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 ultrasonic scissors starting from fundus

Locations

Country	Name	City	State
Finland	Jyvaskyla Central Hospital	Jyvaskyla

Sponsors (1)

Lead Sponsor	Collaborator
Central Finland Hospital District

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Cengiz Y, Dalenbäck J, Edlund G, Israelsson LA, Jänes A, Möller M, Thorell A. Improved outcome after laparoscopic cholecystectomy with ultrasonic dissection: a randomized multicenter trial. Surg Endosc. 2010 Mar;24(3):624-30. doi: 10.1007/s00464-009-0649-2. Epub 2009 Aug 18. — View Citation

Cengiz Y, Jänes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	same day discharge		30 days	Yes
Primary	operative time		30 days	Yes
Primary	intraoperative complications		30 days	Yes
Secondary	analgetic use		30 days	Yes
Secondary	postoperative nausea and vomiting		30 days	Yes
Secondary	readmission		30 days	Yes
Secondary	morbidity		30 days	Yes