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

This study has been completed.
Information provided by (Responsible Party):
Anne Mattila, Central Finland Hospital District Identifier:
First received: March 10, 2012
Last updated: December 10, 2014
Last verified: December 2014

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.

Condition Intervention
Procedure: dissection of gallbladder in laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial

Further study details as provided by Central Finland Hospital District:

Primary Outcome Measures:
  • same day discharge [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • operative time [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • intraoperative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • analgetic use [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • postoperative nausea and vomiting [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • readmission [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 169
Study Start Date: March 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional diathermy hook
Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle
Procedure: dissection of gallbladder in laparoscopic cholecystectomy
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
Active Comparator: ultrasonic dissection
Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus
Procedure: dissection of gallbladder in laparoscopic cholecystectomy
laparoscopic cholecystectomy with ultrasonic scissors starting from fundus

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01553331

Jyvaskyla Central Hospital
Jyvaskyla, Finland, 40620
Sponsors and Collaborators
Central Finland Hospital District
Study Director: Ilmo Kellokumpu, Docent Jyvaskyla Central Hospital
Principal Investigator: Anne K Mattila, MD Jyvaskyla Central Hospital
  More Information

Responsible Party: Anne Mattila, MD, Central Finland Hospital District Identifier: NCT01553331     History of Changes
Other Study ID Numbers: KSSHPB10208
Study First Received: March 10, 2012
Last Updated: December 10, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Central Finland Hospital District:
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on October 08, 2015