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A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy (MC-UsD)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Minilaparotomy vs laparoscopy
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by ultrasoud

  • ASA physical status 1-3
  • Body mass index 18-30
  • AGE 18 - 75 years

Exclusion Criteria:

  • Pregnancy or lactating
  • common bile-duct stones
  • acute cholecystitis
  • previous upper abdominal operation
  • Chirrosis
  • Renal disease
  • Pancreatitis
  • ASA 4-5
  • Participation of any other clinical trial within 30 days before the start of the screening period
  • History of uncontrolled cardiovascular, epileptic disorder, psychosis.

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minilaparotomy cholecystectomy with ultrasonic scissors

Laparoscopic cholecystectomy

Arm Description

Minilaparotomy vs laparoscopy

Minilaparotomy vs laparoscopy

Outcomes

Primary Outcome Measures

Early recovery
Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery

Secondary Outcome Measures

Peroperative outcome
Operative time, time at the operation theatre, bleeding, length of skin incision

Full Information

First Posted
November 6, 2012
Last Updated
November 6, 2012
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01723540
Brief Title
A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy
Acronym
MC-UsD
Official Title
A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minilaparotomy cholecystectomy with ultrasonic scissors
Arm Type
Experimental
Arm Description
Minilaparotomy vs laparoscopy
Arm Title
Laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
Minilaparotomy vs laparoscopy
Intervention Type
Procedure
Intervention Name(s)
Minilaparotomy vs laparoscopy
Intervention Description
MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Early recovery
Description
Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery
Time Frame
One month
Secondary Outcome Measure Information:
Title
Peroperative outcome
Description
Operative time, time at the operation theatre, bleeding, length of skin incision
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by ultrasoud ASA physical status 1-3 Body mass index 18-30 AGE 18 - 75 years Exclusion Criteria: Pregnancy or lactating common bile-duct stones acute cholecystitis previous upper abdominal operation Chirrosis Renal disease Pancreatitis ASA 4-5 Participation of any other clinical trial within 30 days before the start of the screening period History of uncontrolled cardiovascular, epileptic disorder, psychosis.
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland

12. IPD Sharing Statement

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A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy

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