Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558414
• Other study ID #: Llatzer-FSIS
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2012
• Last updated: March 11, 2013
• Start date: April 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2013
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Laparoscopy
• Surgery

Intervention

Procedure:
• SILS Cholecystectomy
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
• FSIS cholecystectomy
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
• Conventional laparoscopy
Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).

Locations

Country	Name	City	State
Spain	Hospital Son Llàtzer	Palma de Mallorca	Illes Balears

Sponsors (2)

Lead Sponsor	Collaborator
Jose F. Noguera	Hospital Mateo Orfila

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Noguera J, Dolz C, Cuadrado A, Olea J, Vilella A, Morales R. Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series. Surg Endosc. 2009 Apr;23(4):876-81. doi: 10.1007/s00464-008-0288-z. Epub 2009 Jan 1. — View Citation

Noguera JF, Cuadrado A, Sánchez-Margallo FM, Dolz C, Asencio JM, Olea JM, Morales R, Lozano L, Vicens JC. Emergency transvaginal hybrid natural orifice transluminal endoscopic surgery. Endoscopy. 2011 May;43(5):442-4. doi: 10.1055/s-0030-1256042. Epub 2010 Dec 16. — View Citation

Sanchez-Margallo FM, Perez FJ, Sanchez MA, Asencio JM, del Carmen Tejonero M, Moreno C, Noguera J. Hybrid notes cholecystectomy in an experimental model of laparoscopic acute cholecystitis. Surg Laparosc Endosc Percutan Tech. 2011 Apr;21(2):e65-9. doi: 10.1097/SLE.0b013e31820a2079. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical safety	Number of patients without clinical problems in the surgery	During surgical intervention	Yes
Secondary	Conversion to other surgical approach	Rate of conversion to conventional laparoscopic surgery and open surgery.	During the surgical intervention	Yes