Back to resultsLaparoscopic Hernia Defect Obliteration With ProFlor-E
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ProFlor laparoscopic technique
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, Laparoscopic inguinal hernia repair, Inguinal hernia defect obliteration, Fixation free hernia repair, Regenerative scaffolds
Eligibility Criteria
Inclusion Criteria:
- patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias
Exclusion Criteria:
- ASA >4 patients
Sites / Locations
- University of Palermo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inguinal hernia repair laparoscopic
Arm Description
recurrent inguinal hernia after open repair or bilateral hernia patients
Outcomes
Primary Outcome Measures
Feasibility of inguinal hernia defect obliteration with ProFlor
Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor
Secondary Outcome Measures
Postoperative pain
assessment of postoperative pain through Visual Analogue Scale
Full Information
NCT ID
NCT04718298
First Posted
July 15, 2020
Last Updated
September 28, 2021
Sponsor
University of Cagliari
1. Study Identification
Unique Protocol Identification Number
NCT04718298
Brief Title
Laparoscopic Hernia Defect Obliteration With ProFlor-E
Official Title
Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect
Detailed Description
The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal hernia, Laparoscopic inguinal hernia repair, Inguinal hernia defect obliteration, Fixation free hernia repair, Regenerative scaffolds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inguinal hernia repair laparoscopic
Arm Type
Experimental
Arm Description
recurrent inguinal hernia after open repair or bilateral hernia patients
Intervention Type
Device
Intervention Name(s)
ProFlor laparoscopic technique
Intervention Description
Inguinal hernia repair laparoscopic
Primary Outcome Measure Information:
Title
Feasibility of inguinal hernia defect obliteration with ProFlor
Description
Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
assessment of postoperative pain through Visual Analogue Scale
Time Frame
from early stage until 18 months postop
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias
Exclusion Criteria:
ASA >4 patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Amato, MD
Organizational Affiliation
University of Cagliari - University of Palermo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Palermo
City
Palermo
State/Province
Please Select
ZIP/Postal Code
90100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21752035
Citation
Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.
Results Reference
background
PubMed Identifier
25626584
Citation
Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.
Results Reference
background
Citation
Amato G, Romano G, Goetze T, Cicero L, Gulotta E, Calò PG, Agrusa A Fixation free inguinal hernia repair with the 3D dynamic responsive prosthesis ProFlor: Features, procedural steps and long-term results. International Journal of Surgery Open 2019; 21:34-4
Results Reference
background
Learn more about this trial
Laparoscopic Hernia Defect Obliteration With ProFlor-E
We'll reach out to this number within 24 hrs