Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy
Primary Purpose
Cholelithiasis, Surgery, Laparoscopy
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
SILS Cholecystectomy
FSIS cholecystectomy
Conventional laparoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Cholelithiasis focused on measuring Cholecystectomy, Minimally invasive surgery, Laparoscopic surgery, Single incision surgery
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
Sites / Locations
- Hospital Son Llàtzer
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
SILS
FSIS
Conventional laparoscopy
Arm Description
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
Cholecystectomy performed by a conventional laparoscopic approach
Outcomes
Primary Outcome Measures
Surgical safety
Number of patients without clinical problems in the surgery
Secondary Outcome Measures
Conversion to other surgical approach
Rate of conversion to conventional laparoscopic surgery and open surgery.
Full Information
NCT ID
NCT01558414
First Posted
March 17, 2012
Last Updated
March 11, 2013
Sponsor
Jose F. Noguera
Collaborators
Hospital Mateo Orfila
1. Study Identification
Unique Protocol Identification Number
NCT01558414
Brief Title
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
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose F. Noguera
Collaborators
Hospital Mateo Orfila
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Surgery, Laparoscopy
Keywords
Cholecystectomy, Minimally invasive surgery, Laparoscopic surgery, Single incision surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SILS
Arm Type
Experimental
Arm Description
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
Arm Title
FSIS
Arm Type
Experimental
Arm Description
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
Arm Title
Conventional laparoscopy
Arm Type
Active Comparator
Arm Description
Cholecystectomy performed by a conventional laparoscopic approach
Intervention Type
Procedure
Intervention Name(s)
SILS Cholecystectomy
Intervention Description
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
Intervention Type
Procedure
Intervention Name(s)
FSIS cholecystectomy
Intervention Description
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopy
Intervention Description
Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).
Primary Outcome Measure Information:
Title
Surgical safety
Description
Number of patients without clinical problems in the surgery
Time Frame
During surgical intervention
Secondary Outcome Measure Information:
Title
Conversion to other surgical approach
Description
Rate of conversion to conventional laparoscopic surgery and open surgery.
Time Frame
During the surgical intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José F Noguera, MD, PhD
Organizational Affiliation
Hospital Son Llàtzer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juan C García, MD
Organizational Affiliation
Hospital Son Llàtzer
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07198
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
21471782
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.
Results Reference
background
PubMed Identifier
21165824
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.
Results Reference
background
PubMed Identifier
19118420
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.
Results Reference
background
PubMed Identifier
23812286
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.
Results Reference
derived
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Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy
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