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Completed

NCT Number: NCT01873638

Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

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.

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Key information

Conditions

Gallstone Disease Biliary Tract Diseases Cholelithiasis Digestive System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy

Procedure

Primary outcomes

  1. Chronic post-surgical pain

    Time frame: Five year outcome

Secondary outcomes

  1. Quality of life

    Time frame: Five year outcome

Other outcomes

  1. Cosmetic satisfaction

    Time frame: Five year outcome

  2. Residual abdominal symptoms

    Time frame: Five year outcome

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 10, 2013
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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