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Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

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ClinicalTrials.gov Identifier: NCT01873638
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Information provided by (Responsible Party):
Matti Eskelinen, Kuopio University Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

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



Primary Outcome Measures :
  1. Chronic post-surgical pain [ Time Frame: Five year outcome ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Five year outcome ]

Other Outcome Measures:
  1. Cosmetic satisfaction [ Time Frame: Five year outcome ]
  2. Residual abdominal symptoms [ Time Frame: Five year outcome ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873638


Locations
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Finland
Kuopio University Hospital
Kuopio, Northern Savo, Finland, 70029
Sponsors and Collaborators
Kuopio University Hospital

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Responsible Party: Matti Eskelinen, professor, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01873638     History of Changes
Other Study ID Numbers: KUH5200630
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2013

Keywords provided by Matti Eskelinen, Kuopio University Hospital:
5-year outcome after cholecystectomy

Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical