NCT01558414

Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Jose F. Noguera · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a transumbilical single site incision will be performed with two different manners: single-port device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the control one, a conventional laparoscopic approach. The trial is designed as a pilot study to assess, as main objective, if these two endoscopic approaches have the same security and effectiveness in cholecystectomy. Hypothesis: Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy. Objectives: Main objective: Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy. Secondary objectives: Investigate the differences in the rate of conversion to open surgery between different surgical approaches. Investigate the differences in the rate of wound infection between the different surgical approaches. Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches. Investigate whether there are differences in the rate of overall complications, all-cause mortality and the cost between different surgical approaches.

Detailed description

Inclusion criteria: * Patients affected with symptomatic cholelithiasis with elective surgical indication, not urgent, aged between 18 and 65. * Signing of informed consent for cholecystectomy and specific consent for the trial. * Anesthetic risk ASA I-II. Exclusion criteria: * Presence of acute cholecystitis and / or suspicion of occupation of the main bile duct. * ASA III and higher.

Conditions

• Cholelithiasis
• Surgery
• Laparoscopy

Interventions

Type	Name	Description
PROCEDURE	SILS Cholecystectomy	Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
PROCEDURE	FSIS cholecystectomy	Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
PROCEDURE	Conventional laparoscopy	Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-10-01
• Completion: 2012-11-01
• First posted: 2012-03-20
• Last updated: 2013-03-12

Locations

1 site across 1 country: Spain