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

May 17, 2011 updated by: Providence Health & Services

A Randomized 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Single port laparoscopic device
Device: Laparoscopic cholecystectomy surgery
Single port laparoscopic cholecystectomy surgery versus a standard four port device.
Other Names:
  • ACS Triport, Advanced Surgical Concepts, Ireland
Active Comparator: 2
Four-port laparoscopic device
Device: Laparoscopic cholecystectomy surgery
Single port laparoscopic cholecystectomy surgery versus a standard four port device.
Other Names:
  • ACS Triport, Advanced Surgical Concepts, Ireland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3-6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Investigators

  • Principal Investigator: Paul D Hansen, MD, Providence Health & Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • PHS IRB # 09-14A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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