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NCT Number: NCT01558414

Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for 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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases Laparoscopy Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SILS Cholecystectomy

Procedure

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

FSIS cholecystectomy

Procedure

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

Conventional laparoscopy

Procedure

Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).

Primary outcomes

  1. Surgical safety

    Time frame: During surgical intervention

    Number of patients without clinical problems in the surgery

Secondary outcomes

  1. Conversion to other surgical approach

    Time frame: During the surgical intervention

    Rate of conversion to conventional laparoscopic surgery and open surgery.

Sponsors and collaborators

Lead sponsor

Jose F. Noguera

Other

Collaborators

  • Hospital Mateo Orfila

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Mar 20, 2012
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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