Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Sponsor

Jose F. Noguera (Other)

Overall Status

Completed

CT.gov ID

NCT01558414

Collaborator

Hospital Mateo Orfila (Other)

Enrollment

Location

Arms

19.1

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cholelithiasis Surgery Laparoscopy	Procedure: SILS Cholecystectomy Procedure: FSIS cholecystectomy Procedure: Conventional laparoscopy	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SILS Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device	Procedure: SILS Cholecystectomy Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
Experimental: FSIS Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus	Procedure: FSIS cholecystectomy Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
Active Comparator: Conventional laparoscopy Cholecystectomy performed by a conventional laparoscopic approach	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).

Arm

Intervention/Treatment

Experimental: SILS

Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device

Procedure: SILS Cholecystectomy

Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device

Experimental: FSIS

Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus

Procedure: FSIS cholecystectomy

Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus

Active Comparator: Conventional laparoscopy

Cholecystectomy performed by a conventional laparoscopic approach

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).

Outcome Measures

Primary Outcome Measures

Surgical safety [During surgical intervention]
Number of patients without clinical problems in the surgery

Secondary Outcome Measures

Conversion to other surgical approach [During the surgical intervention]
Rate of conversion to conventional laparoscopic surgery and open surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age over 18 and under 65
symptomatic cholelithiasis with an indication for laparoscopic surgery
signed specific informed consent including specific information of the new surgical approach
ASA 1 and 2.

Exclusion Criteria:

current or previous cholecystitis
current or previous suspected bile duct's problems
previous abdominal surgery
umbilical and other abdominal hernias
some other condition with increased risk to infection or abdominal wall problems.
ASA 3 and more