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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014