Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

NCT01558414 | Completed Phase 3

• 1 other identifier: Llatzer-FSIS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiasis; Surgery; Laparoscopy

Keywords

Cholecystectomy; Minimally invasive surgery; Laparoscopic surgery; Single incision surgery

Outcome Measures

Primary Outcomes (1)

• Surgical safety

  Number of patients without clinical problems in the surgery

  During surgical intervention

Secondary Outcomes (1)

• Conversion to other surgical approach

  During the surgical intervention

Study Arms (3)

SILS

EXPERIMENTAL

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

Procedure: SILS Cholecystectomy

FSIS

EXPERIMENTAL

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

Procedure: FSIS cholecystectomy

Conventional laparoscopy

ACTIVE COMPARATOR

Cholecystectomy performed by a conventional laparoscopic approach

Procedure: Conventional laparoscopy

Interventions

SILS Cholecystectomy PROCEDURE

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

SILS

FSIS cholecystectomy PROCEDURE

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

FSIS

Conventional laparoscopy PROCEDURE

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

Conventional laparoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose F. Noguera: lead
• Hospital Mateo Orfila: collaborator

Study Sites (1)

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Related Publications (4)

• 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.

  PMID: 21471782 BACKGROUND

• Noguera JF, Cuadrado A, Sanchez-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.

  PMID: 21165824 BACKGROUND

• 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.

  PMID: 19118420 BACKGROUND

• Noguera J, Tejada S, Tortajada C, Sanchez A, Munoz J. Prospective, randomized clinical trial comparing the use of a single-port device with that of a flexible endoscope with no other device for transumbilical cholecystectomy: LLATZER-FSIS pilot study. Surg Endosc. 2013 Nov;27(11):4284-90. doi: 10.1007/s00464-013-3044-y. Epub 2013 Jun 29.

  PMID: 23812286 DERIVED

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• José F Noguera, MD, PhD

  Hospital Son Llàtzer

  STUDY DIRECTOR

• Juan C García, MD

  Hospital Son Llàtzer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Department of Surgery

Study Record Dates

• First Submitted: March 17, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2012
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

ES (1)