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Completed

NCT Number: NCT01553331

Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook

Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.

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Key information

Conditions

Cholecystolithiasis Biliary Tract Diseases Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jyvaskyla Central Hospital

Jyväskylä, Jyvaskyla, 40620, Finland

About this study

After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-II
  • BMI under 35
  • normal liver enzymes
  • no bile duct dilatation in ultrasound
  • cholecystolithiasis

Exclusion criteria

  • NSAID allergy
  • previous upper gi-surgery
  • common bile duct stones in preoperative imaging
  • history of severe acute pancreatitis

Treatment and study plan

dissection of gallbladder in laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot

Primary outcomes

  1. same day discharge

    Time frame: 30 days

  2. operative time

    Time frame: 30 days

  3. intraoperative complications

    Time frame: 30 days

Secondary outcomes

  1. analgetic use

    Time frame: 30 days

  2. postoperative nausea and vomiting

    Time frame: 30 days

  3. readmission

    Time frame: 30 days

  4. morbidity

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Central Finland Hospital District

Other

Registry information

Official study title

Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2012
Registry last updated
Dec 11, 2014

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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