Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Jose F. Noguera

Status and phase: Completed; Phase 3

Conditions: Laparoscopy; Surgery; Cholelithiasis

Treatments: Procedure: Conventional laparoscopy; Procedure: SILS Cholecystectomy; Procedure: FSIS cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01558414

Llatzer-FSIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

SILS

Experimental group

Description:

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

Treatment:

Procedure: SILS Cholecystectomy

FSIS

Experimental group

Description:

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

Treatment:

Procedure: FSIS cholecystectomy

Conventional laparoscopy

Active Comparator group

Description:

Cholecystectomy performed by a conventional laparoscopic approach

Treatment:

Procedure: Conventional laparoscopy