Postoperative Pain
Conditions
Keywords
single port cholecystectomy
Brief summary
This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.
Detailed description
The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures. Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies. The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.
Interventions
Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Four port laparoscopic cholecystectomy surgery
Sponsors
Study design
Eligibility
Inclusion criteria
* Biliary cholic * Biliary dyskinesia * Gallbladder polyps * Other diagnosis at the discretion of the surgeon
Exclusion criteria
* History of Acute cholecystitis * Jaundice * Choledocolithiasis * History of Pancreatitis * Severe comorbidity * BMI \> 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative pain scores (visual analogue pain scale from 0-10) | Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Patient-assessed cosmesis on the Visual Analogue Scale | 30 days after surgery |
Countries
Italy