Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy
Condition: Cholelithiasis; Surgery; Laparoscopy
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Surgical Wound
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): SILS Cholecystectomy; FSIS cholecystectomy; Conventional laparoscopy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device; Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus; Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholecystectomy; Minimally invasive surgery; Laparoscopic surgery; Single incision surgery