Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: Four port laparoscopic cholecystectomy surgery; Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)

• Registration Number: NCT01348620
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-26
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-04
• Last Update Submitted: 2011-05-04
• Study First Posted: 2011-05-05
• Last Update Posted: 2011-05-05
• Primary Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Four-port laparoscopic device	Four port laparoscopic cholecystectomy surgery	-
Single port laparoscopic device	Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient-assessed cosmesis on the Visual Analogue Scale	30 days after surgery

Trial Locations

Locations (1)

Sacro Cuore - Don Calabria Hospital; 🇮🇹 Negrar, Verona, Italy