Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholelithiasis, Surgery, Laparoscopy

Intervention / Treatment
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* Procedure: SILS Cholecystectomy
* Procedure: FSIS cholecystectomy
* Procedure: Conventional laparoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SILS<br>Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device | Procedure: SILS Cholecystectomy<br>* Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device<br>|
| Experimental: FSIS<br>Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus | Procedure: FSIS cholecystectomy<br>* Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus<br>|
| Active Comparator: Conventional laparoscopy<br>Cholecystectomy performed by a conventional laparoscopic approach | Procedure: Conventional laparoscopy<br>* Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical safety | 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 | Rate of conversion to conventional laparoscopic surgery and open surgery. | During the surgical intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecystectomy, Minimally invasive surgery, Laparoscopic surgery, Single incision surgery