Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

Kuopio University Hospital

Status: Completed

Conditions: Gallstone Disease

Treatments: Procedure: Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01873638

KUH5200630

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Minilaparotomy

Other group

Description:

Minilaparotomy cholecystectomy as a day surgery

Treatment:

Procedure: Cholecystectomy

Laparoscopy

Other group

Description:

Laparoscopic cholecystectomy as a day surgery

Treatment:

Procedure: Cholecystectomy