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

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892879
• Other study ID #: PHS IRB # 09-14A
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2009
• Last updated: May 17, 2011
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic

Intervention

Device:
• Laparoscopic cholecystectomy surgery
Single port laparoscopic cholecystectomy surgery versus a standard four port device.

Locations

Country	Name	City	State
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.		3-6 weeks	Yes