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

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ClinicalTrials.gov Identifier: NCT00892879
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
Providence Health & Services

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
Cholecystectomy, Laparoscopic Device: Laparoscopic cholecystectomy surgery Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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 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




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. [ Time Frame: 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. [ Time Frame: 3-6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011