Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

Gallstone Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873638
• Other study ID #: KUH5200630
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: June 7, 2013
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2013
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Advisory Board on Health Care EthicsFinland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone Disease
• Gallstones

Intervention

Procedure:
• Cholecystectomy

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cosmetic satisfaction		Five year outcome	Yes
Other	Residual abdominal symptoms		Five year outcome	Yes
Primary	Chronic post-surgical pain		Five year outcome	Yes
Secondary	Quality of life		Five year outcome	Yes