Cholecystectomy, Laparoscopic
Conditions
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.
Interventions
DEVICELaparoscopic cholecystectomy surgery
Single port laparoscopic cholecystectomy surgery versus a standard four port device.
Sponsors
Providence Health & Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy. | 3-6 weeks |
Countries
United States
Outcome results
None listed