Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

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.

Conditions

• Cholelithiasis
• Surgery
• Laparoscopy

Interventions

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).

Sponsors & Collaborators

• Hospital Mateo Orfila

  collaborator OTHER

• Jose F. Noguera

  lead OTHER

Principal Investigators

• José F Noguera, MD, PhD · Hospital Son Llàtzer

• Juan C García, MD · Hospital Son Llàtzer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2011-10-31

Completion

2012-11-30

Countries

• Spain

Study Locations