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

This study has been completed.
Sponsor:
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00892879
First received: April 27, 2009
Last updated: May 17, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Cholecystectomy, Laparoscopic
 Device: Laparoscopic cholecystectomy surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy

Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single port laparoscopic device
 Device: Laparoscopic cholecystectomy surgery
Single port laparoscopic cholecystectomy surgery versus a standard four port device.
Other Name: 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 Name: ACS Triport, Advanced Surgical Concepts, Ireland

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892879

Locations
United States, Oregon
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
  More Information

No publications provided by Providence Health & Services

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul Hansen, MD, Providence Health & Services
ClinicalTrials.gov Identifier: NCT00892879     History of Changes
Other Study ID Numbers: PHS IRB # 09-14A
Study First Received: April 27, 2009
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013