Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

This study has been completed.
Sponsor:
Collaborator:
Hospital Mateo Orfila
Information provided by (Responsible Party):
Jose F. Noguera, Hospital Son Llatzer
ClinicalTrials.gov Identifier:
NCT01558414
First received: March 17, 2012
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Cholelithiasis
Surgery
Laparoscopy
Procedure: SILS Cholecystectomy
Procedure: FSIS cholecystectomy
Procedure: Conventional laparoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Hospital Son Llatzer:

Primary Outcome Measures:
  • Surgical safety [ Time Frame: During surgical intervention ] [ Designated as safety issue: Yes ]
    Number of patients without clinical problems in the surgery


Secondary Outcome Measures:
  • Conversion to other surgical approach [ Time Frame: During the surgical intervention ] [ Designated as safety issue: Yes ]
    Rate of conversion to conventional laparoscopic surgery and open surgery.


Enrollment: 60
Study Start Date: April 2011
Study Completion Date: November 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558414

Locations
Spain
Hospital Son Llàtzer
Palma de Mallorca, Illes Balears, Spain, 07198
Sponsors and Collaborators
Jose F. Noguera
Hospital Mateo Orfila
Investigators
Study Director: José F Noguera, MD, PhD Hospital Son Llàtzer
Study Chair: Juan C García, MD Hospital Son Llàtzer
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose F. Noguera, Chief Department of Surgery, Hospital Son Llatzer
ClinicalTrials.gov Identifier: NCT01558414     History of Changes
Other Study ID Numbers: Llatzer-FSIS
Study First Received: March 17, 2012
Last Updated: March 11, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Son Llatzer:
Cholecystectomy
Minimally invasive surgery
Laparoscopic surgery
Single incision surgery

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014