MedPath

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

Phase 3
Completed
Conditions
Cholecystectomy, Laparoscopic
Registration Number
NCT00892879
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.3-6 weeks

Trial Locations

Locations (1)

Providence Portland Medical Center

🇺🇸

Portland, Oregon, United States

Providence Portland Medical Center
🇺🇸Portland, Oregon, United States

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