Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

NCT00835250

Cholelithiasis

COMPLETED PHASE3

A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy

NCT02375529

Cholelithiasis

COMPLETED NA

Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

NCT00981604

Cholelithiasis Biliary Dyskinesia

COMPLETED NA

Single Incision Versus Three Port Laparoscopic Cholecystectomy

NCT03067038

Laparoscopic Cholecystectomy

COMPLETED NA

Solo Single Incision Laparoscopic Cholecystectomy

NCT03018964

Cholecystectomy, Laparoscopic

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholelithiasis Surgery Laparoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SILS

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

Group Type EXPERIMENTAL

SILS Cholecystectomy

Intervention Type PROCEDURE

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

FSIS

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

Group Type EXPERIMENTAL

FSIS cholecystectomy

Intervention Type PROCEDURE

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

Conventional laparoscopy

Cholecystectomy performed by a conventional laparoscopic approach

Group Type ACTIVE_COMPARATOR

Conventional laparoscopy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SILS Cholecystectomy

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

Intervention Type PROCEDURE

FSIS cholecystectomy

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

Intervention Type PROCEDURE

Conventional laparoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No