Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cholelithiasis Surgery Laparoscopy |
Procedure: SILS Cholecystectomy Procedure: FSIS cholecystectomy Procedure: Conventional laparoscopy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy |
- Surgical safety [ Time Frame: During surgical intervention ] [ Designated as safety issue: Yes ]Number of patients without clinical problems in the surgery
- Conversion to other surgical approach [ Time Frame: During the surgical intervention ] [ Designated as safety issue: Yes ]Rate of conversion to conventional laparoscopic surgery and open surgery.
| Enrollment: | 60 |
| Study Start Date: | April 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SILS
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
|
Procedure: SILS Cholecystectomy
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
|
|
Experimental: FSIS
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
|
Procedure: FSIS cholecystectomy
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
|
|
Active Comparator: Conventional laparoscopy
Cholecystectomy performed by a conventional laparoscopic approach
|
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Spain | |
| Hospital Son Llàtzer | |
| Palma de Mallorca, Illes Balears, Spain, 07198 | |
| Study Director: | José F Noguera, MD, PhD | Hospital Son Llàtzer |
| Study Chair: | Juan C García, MD | Hospital Son Llàtzer |
More Information
Publications:
| Responsible Party: | Jose F. Noguera, Chief Department of Surgery, Hospital Son Llatzer |
| ClinicalTrials.gov Identifier: | NCT01558414 History of Changes |
| Other Study ID Numbers: | Llatzer-FSIS |
| Study First Received: | March 17, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Hospital Son Llatzer:
|
Cholecystectomy Minimally invasive surgery Laparoscopic surgery Single incision surgery |
Additional relevant MeSH terms:
|
Cholelithiasis Cholecystolithiasis Gallstones Biliary Tract Diseases |
Digestive System Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013