A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Providence Health & Services
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
1
Single port laparoscopic device
Intervention: Laparoscopic cholecystectomy surgery (Device)
2
Four-port laparoscopic device
Intervention: Laparoscopic cholecystectomy surgery (Device)
Outcomes
Primary Outcomes
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 Outcomes
- The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.(3-6 weeks)