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

Providence Health & Services50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cholecystectomy, Laparoscopic

Interventions

Laparoscopic cholecystectomy surgeryDEVICE

Single port laparoscopic cholecystectomy surgery versus a standard four port device.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Providence Portland Medical Center

Portland, Oregon, United States

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.

Time frame: 3-6 weeks

Data from ClinicalTrials.gov

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