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

Phase 3

Completed

• Conditions: Cholecystectomy, Laparoscopic
• Interventions: Device: Laparoscopic cholecystectomy surgery

• 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

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-17
• Last Update Posted: 2011-05-18

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

Arm && Interventions

Group	Intervention	Description
1	Laparoscopic cholecystectomy surgery	Single port laparoscopic device
2	Laparoscopic cholecystectomy surgery	Four-port laparoscopic device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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