Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

March 11, 2013 updated by: Jose F. Noguera

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07198
        • Hospital Son Llatzer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical safety
Time Frame: During surgical intervention
Number of patients without clinical problems in the surgery
During surgical intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to other surgical approach
Time Frame: During the surgical intervention
Rate of conversion to conventional laparoscopic surgery and open surgery.
During the surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose F. Noguera

Collaborators

Hospital Mateo Orfila

Investigators

  • Study Director: José F Noguera, MD, PhD, Hospital Son Llatzer
  • Study Chair: Juan C García, MD, Hospital Son Llatzer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

March 17, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Llatzer-FSIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on SILS Cholecystectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe