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

Primary Purpose

Cholecystolithiasis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
dissection of gallbladder in laparoscopic cholecystectomy
dissection of gallbladder in laparoscopic cholecystectomy
Sponsored by
Central Finland Hospital District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystolithiasis focused on measuring laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jyvaskyla Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

conventional diathermy hook

ultrasonic dissection

Arm Description

Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle

Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus

Outcomes

Primary Outcome Measures

same day discharge
operative time
intraoperative complications

Secondary Outcome Measures

analgetic use
postoperative nausea and vomiting
readmission
morbidity

Full Information

First Posted
March 10, 2012
Last Updated
December 10, 2014
Sponsor
Central Finland Hospital District
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1. Study Identification

Unique Protocol Identification Number
NCT01553331
Brief Title
Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook
Official Title
Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Finland Hospital District

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
Keywords
laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional diathermy hook
Arm Type
Active Comparator
Arm Description
Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle
Arm Title
ultrasonic dissection
Arm Type
Active Comparator
Arm Description
Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus
Intervention Type
Procedure
Intervention Name(s)
dissection of gallbladder in laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
Intervention Type
Procedure
Intervention Name(s)
dissection of gallbladder in laparoscopic cholecystectomy
Intervention Description
laparoscopic cholecystectomy with ultrasonic scissors starting from fundus
Primary Outcome Measure Information:
Title
same day discharge
Time Frame
30 days
Title
operative time
Time Frame
30 days
Title
intraoperative complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
analgetic use
Time Frame
30 days
Title
postoperative nausea and vomiting
Time Frame
30 days
Title
readmission
Time Frame
30 days
Title
morbidity
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilmo Kellokumpu, Docent
Organizational Affiliation
Jyvaskyla Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne K Mattila, MD
Organizational Affiliation
Jyvaskyla Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jyvaskyla Central Hospital
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15880649
Citation
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.
Results Reference
background
PubMed Identifier
19688393
Citation
Cengiz 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.
Results Reference
background

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

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