Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

• Sponsor: Kuopio University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01873638
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gallstone Disease	Procedure: Cholecystectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: Minilaparotomy Minilaparotomy cholecystectomy as a day surgery	Procedure: Cholecystectomy
Other: Laparoscopy Laparoscopic cholecystectomy as a day surgery	Procedure: Cholecystectomy

Outcome Measures

Primary Outcome Measures

1. Chronic post-surgical pain [Five year outcome]

Secondary Outcome Measures

1. Quality of life [Five year outcome]

Other Outcome Measures

1. Cosmetic satisfaction [Five year outcome]

2. Residual abdominal symptoms [Five year outcome]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuopio University Hospital	Kuopio	Northern Savo	Finland	70029

Sponsors and Collaborators

• Kuopio University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matti Eskelinen, professor, Kuopio University Hospital
• ClinicalTrials.gov Identifier: NCT01873638
• Other Study ID Numbers: KUH5200630
• First Posted: Jun 10, 2013
• Last Update Posted: Jun 10, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Matti Eskelinen, professor, Kuopio University Hospital: 5-year outcome after cholecystectomy
• Additional relevant MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis

Study Results

No Results Posted as of Jun 10, 2013