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Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

Primary Purpose

Gallstone Disease

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

About this trial

This is an interventional treatment trial for Gallstone Disease focused on measuring 5-year outcome after cholecystectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Cholelithiasis confirmed by preoperative ulrasound
  • No significant co-morbidities
  • The ASA physical status classification 1 or 2
  • Age 18 to 65 yrs.
  • BMI less than 35
  • Less than a one hour journey from hospital to home
  • Patient´s own motivation to daysurgery

Exclusion Criteria:

  • Elevated liver laboratory tests
  • Earlier jaundice
  • A suspicion or verified stones in the common bile duct
  • Acute cholecystitis
  • A history of pancreatitis
  • Hepatic cirrhosis
  • Suspicion of cancer
  • Previous open upper abdominal surgery
  • Asthma
  • Peptic ulcer
  • Bleeding disorders

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Minilaparotomy

Laparoscopy

Arm Description

Minilaparotomy cholecystectomy as a day surgery

Laparoscopic cholecystectomy as a day surgery

Outcomes

Primary Outcome Measures

Chronic post-surgical pain

Secondary Outcome Measures

Quality of life

Full Information

First Posted
June 4, 2013
Last Updated
June 7, 2013
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01873638
Brief Title
Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone Disease
Keywords
5-year outcome after cholecystectomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Minilaparotomy
Arm Type
Other
Arm Description
Minilaparotomy cholecystectomy as a day surgery
Arm Title
Laparoscopy
Arm Type
Other
Arm Description
Laparoscopic cholecystectomy as a day surgery
Intervention Type
Procedure
Intervention Name(s)
Cholecystectomy
Primary Outcome Measure Information:
Title
Chronic post-surgical pain
Time Frame
Five year outcome
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
Five year outcome
Other Pre-specified Outcome Measures:
Title
Cosmetic satisfaction
Time Frame
Five year outcome
Title
Residual abdominal symptoms
Time Frame
Five year outcome

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: Cholelithiasis confirmed by preoperative ulrasound No significant co-morbidities The ASA physical status classification 1 or 2 Age 18 to 65 yrs. BMI less than 35 Less than a one hour journey from hospital to home Patient´s own motivation to daysurgery Exclusion Criteria: Elevated liver laboratory tests Earlier jaundice A suspicion or verified stones in the common bile duct Acute cholecystitis A history of pancreatitis Hepatic cirrhosis Suspicion of cancer Previous open upper abdominal surgery Asthma Peptic ulcer Bleeding disorders
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

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Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

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