Skip to main content
OpenTrials
Completed

NCT Number: NCT00892879

A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy

This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholecystectomy, Laparoscopic

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pre-operative diagnosis of one of the following:
  • Pancreatic cholecystitis
  • Biliary cholic
  • Biliary dyskinesia
  • Choledocholithiasis status post endoscopic retrograde cholangiopancreatography/sphincterotomy
  • Gallbladder polyps
  • Other diagnosis at the discretion of the surgeon

Exclusion criteria

  • Acute cholecystitis
  • Gallstones > 2.5cm in length on ultrasound
  • Suspected presence of common duct stones
  • History of jaundice
  • History of gallstone pancreatic

Treatment and study plan

Laparoscopic cholecystectomy surgery

Device

Single port laparoscopic cholecystectomy surgery versus a standard four port device.

Other names: ACS Triport, Advanced Surgical Concepts, Ireland

Primary outcomes

  1. Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test.

    Time frame: 3-6 weeks

Secondary outcomes

  1. The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.

    Time frame: 3-6 weeks

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Registry information

Official study title

A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 5, 2009
Registry last updated
May 18, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.