Cholelithiasis, Surgery, Laparoscopy
Conditions
Keywords
Cholecystectomy, Minimally invasive surgery, Laparoscopic surgery, Single incision surgery
Brief 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.
Interventions
PROCEDURESILS Cholecystectomy
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
PROCEDUREFSIS cholecystectomy
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
PROCEDUREConventional laparoscopy
Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).
Sponsors
Hospital Mateo Orfila
Jose F. Noguera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical safety | During surgical intervention | Number of patients without clinical problems in the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to other surgical approach | During the surgical intervention | Rate of conversion to conventional laparoscopic surgery and open surgery. |
Countries
Spain
Outcome results
None listed