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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553331
First Posted: March 14, 2012
Last Update Posted: December 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anne Mattila, Central Finland Hospital District
  Purpose
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
Cholecystolithiasis Procedure: dissection of gallbladder in laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Anne Mattila, Central Finland Hospital District:

Primary Outcome Measures:
  • same day discharge [ Time Frame: 30 days ]
  • operative time [ Time Frame: 30 days ]
  • intraoperative complications [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • analgetic use [ Time Frame: 30 days ]
  • postoperative nausea and vomiting [ Time Frame: 30 days ]
  • readmission [ Time Frame: 30 days ]
  • morbidity [ Time Frame: 30 days ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553331


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

Publications:
Responsible Party: Anne Mattila, MD, Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT01553331     History of Changes
Other Study ID Numbers: KSSHPB10208
First Submitted: March 10, 2012
First Posted: March 14, 2012
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Anne Mattila, Central Finland Hospital District:
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical