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Completed

NCT Number: NCT00732550

Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Cholecystitis Digestive System Diseases Gallbladder Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization Ein-Kerem campus

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-60
  • symptomatic cholelithiasis
  • ASA 1-2

Exclusion criteria

  • pregnancy
  • morbid obesity with BMI>35
  • other gallbladder pathology like polyps or tumor
  • history of upper abdomen laparotomy
  • suspected choledocholithiasis

Treatment and study plan

Single trocar cholecystectomy

Procedure

Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach

Standard Laparoscopic Cholecystectomy

Procedure

Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy

Primary outcomes

  1. To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.

    Time frame: Continuous

Secondary outcomes

  1. To assess pain associated with the single trocar approach

    Time frame: Continuous

  2. To assess scar formation associated with single trocar approach

    Time frame: Continuous

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Aug 12, 2008
Registry last updated
Jul 30, 2020

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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