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

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ClinicalTrials.gov Identifier: NCT01553331
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Anne Mattila, 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.

Condition or disease Intervention/treatment
Cholecystolithiasis Procedure: dissection of gallbladder in laparoscopic cholecystectomy

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
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
Study Start Date : March 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. same day discharge [ Time Frame: 30 days ]
  2. operative time [ Time Frame: 30 days ]
  3. intraoperative complications [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. analgetic use [ Time Frame: 30 days ]
  2. postoperative nausea and vomiting [ Time Frame: 30 days ]
  3. readmission [ Time Frame: 30 days ]
  4. morbidity [ Time Frame: 30 days ]


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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

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

Publications:
Responsible Party: Anne Mattila, MD, Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT01553331     History of Changes
Other Study ID Numbers: KSSHPB10208
First Posted: March 14, 2012    Key Record Dates
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