Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

Kuopio University Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gallstone Disease

Interventions

CholecystectomyPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Outcomes

Primary Outcomes

Chronic post-surgical pain

Time frame: Five year outcome

Secondary Outcomes

Quality of life

Time frame: Five year outcome

Data from ClinicalTrials.gov

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