Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

NCT ID: NCT01873638

Last Updated: 2013-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gallstone Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minilaparotomy

Minilaparotomy cholecystectomy as a day surgery

Group Type OTHER

Cholecystectomy

Intervention Type PROCEDURE

Laparoscopy

Laparoscopic cholecystectomy as a day surgery

Group Type OTHER

Cholecystectomy

Intervention Type PROCEDURE

Interventions

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Cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matti Eskelinen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5200630

Identifier Type: -

Identifier Source: org_study_id

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