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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01873638
Other study ID # KUH5200630
Secondary ID
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


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
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