Clinical trial NCT01558414: Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy
Official title: Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholelithiasis
Surgery
Laparoscopy
Keywords: Cholecystectomy
Minimally invasive surgery
Laparoscopic surgery
Single incision surgery
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
Collaborators: name: Hospital Mateo Orfila
First posted: 2012-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: Surgical safety
timeFrame: During surgical intervention
Secondary outcomes:
measure: Conversion to other surgical approach
timeFrame: During the surgical intervention
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Illes Balears
Study officials:
affiliation: Hospital Son Llàtzer
name: José F Noguera, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Son Llàtzer
name: Juan C García, MD
role: STUDY_CHAIR
References:
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.
citation: 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.
citation: 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.
citation: 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.