Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook
1 other identifier
interventional
169
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 10, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 11, 2014
December 1, 2014
2.6 years
March 10, 2012
December 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
same day discharge
30 days
operative time
30 days
intraoperative complications
30 days
Secondary Outcomes (4)
analgetic use
30 days
postoperative nausea and vomiting
30 days
readmission
30 days
morbidity
30 days
Study Arms (2)
conventional diathermy hook
ACTIVE COMPARATORLaparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle
ultrasonic dissection
ACTIVE COMPARATORLaparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus
Interventions
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
Eligibility Criteria
You may qualify if:
- ASA I-II
- BMI under 35
- normal liver enzymes
- no bile duct dilatation in ultrasound
- cholecystolithiasis
You may not qualify if:
- NSAID allergy
- previous upper gi-surgery
- common bile duct stones in preoperative imaging
- history of severe acute pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jyvaskyla Central Hospital
Jyväskylä, Jyvaskyla, 40620, Finland
Related Publications (2)
Cengiz Y, Janes 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. doi: 10.1002/bjs.4982.
PMID: 15880649BACKGROUNDCengiz Y, Dalenback J, Edlund G, Israelsson LA, Janes A, Moller 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.
PMID: 19688393BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ilmo Kellokumpu, Docent
Jyvaskyla Central Hospital
- PRINCIPAL INVESTIGATOR
Anne K Mattila, MD
Jyvaskyla Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 10, 2012
First Posted
March 14, 2012
Study Start
March 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 11, 2014
Record last verified: 2014-12