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

Sponsor
Providence Health & Services (Other)
Overall Status
Completed
CT.gov ID
NCT00892879
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
21.9
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Laparoscopic cholecystectomy surgery
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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. [3-6 weeks]

    Secondary Outcome Measures

    1. The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy. [3-6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Portland Medical Center Portland Oregon United States 97213

    Sponsors and Collaborators

    • Providence Health & Services

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00892879
    Other Study ID Numbers:
    • PHS IRB # 09-14A
    First Posted:
    May 5, 2009
    Last Update Posted:
    May 18, 2011
    Last Verified:
    May 1, 2011

    Study Results

    No Results Posted as of May 18, 2011