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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Central Finland Hospital District
Sponsor:
Information provided by (Responsible Party):
Anne Mattila, Central Finland Hospital District
ClinicalTrials.gov Identifier:
NCT01553331
First received: March 10, 2012
Last updated: October 28, 2014
Last verified: October 2014
  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
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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 180
Study Start Date: March 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553331

Contacts
Contact: Anne K Mattila, MD +358-14-2695050 anne.mattila@ksshp.fi

Locations
Finland
Jyvaskyla Central Hospital Recruiting
Jyvaskyla, Finland, 40620
Contact: Anne K Mattila, MD    +358-14-2695050    anne.mattila@ksshp.fi   
Principal Investigator: Anne K Mattila, MD         
Principal Investigator: Johanna M Mrena, MD,PhD         
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
Study First Received: March 10, 2012
Last Updated: October 28, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Central Finland Hospital District:
laparoscopic cholecystectomy

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

ClinicalTrials.gov processed this record on November 20, 2014