Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair (PTFE)
Primary Purpose
Hernia, Inguinal
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Totally Extraperitoneal laparoscopic inguinal hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal
Eligibility Criteria
Inclusion Criteria:
- male patients
- 20-80 years old
- Primary Bilateral Hernia
Exclusion Criteria:
- Women
- BMI >35
- Recurrent hernias
- Previous infraumbilical laparotomy
- Inguinoscrotal hernias
Sites / Locations
- Hospital Universitario Virgen del Rocio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LP PTFE
SP-PPL
Arm Description
Placement of Large Pore PTFE mesh for inguinal hernia treatment
Placement of Small Pore polypropylene mesh for inguinal hernia treatment
Outcomes
Primary Outcome Measures
Postoperative Discomfort
Postoperative Discomfort in the inguinal area is assessed using a visual analog scale (VAS)on the first 12 postoperative months.
Discomfort is defined as a disturbing sensation without influencing normal activities of the patient
Secondary Outcome Measures
Postoperative Pain
Postoperative pain in the inguinal area is assessed using a visual analog scale (VAS)on the first 12 postoperative months.
Pain is described as an unpleasant sensation that interferes with the normal activities of the patient
Recurrence
Reappearance of a inguinal hernia in a previous operated inguinal hernia.
Postoperative complications
Complications such as seroma or haematoma in groin area.
Full Information
NCT ID
NCT02023203
First Posted
December 13, 2013
Last Updated
December 23, 2013
Sponsor
Hospitales Universitarios Virgen del Rocío
1. Study Identification
Unique Protocol Identification Number
NCT02023203
Brief Title
Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair
Acronym
PTFE
Official Title
Prospective Randomized Clinical Trial Comparing Microporous Polypropylene Mesh and Flexible Macroporous Polytetrafluoroethylene Mesh in Totally Extraperitoneal Laparoscopic Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospitales Universitarios Virgen del Rocío
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inguinal hernia repair is one of the most commonly performed surgeries around the world. It accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of 27% in males and 3% in females. Since the modern concept of surgical hernia repair described by Bassini in 1887, with the technique that bears his name, several techniques have been developed in the last century in order to improve surgical outcomes after inguinal hernia repair.
Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach were described and developed, until Lichtenstein described the tension-free hernioplasty concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable Improvements were observed with this technique in terms of recurrence, pain, and discomfort in comparison with previous tension repairs. Considerable advantages over open repair have been obtained with the introduction of minimally invasive surgery to inguinal hernia repair, in terms of patient comfort and recurrence rates.
Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by Lichtenstein. First generation meshes were manufactured using more material and for this reason they have been described as heavyweight meshes. New generation meshes have been designed with less material in order to diminish the inflammatory response and foreign body reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes. The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size of the pore and lately it has been reported that one of the main aspects related to prosthetic materials is pore size. Large pore meshes use less material, consequently they have been associated with a better tissue ingrowth. The large pore of lightweight meshes is conditioned by the less amount of material used.
All previous studies compare both light and heavyweight polypropylene meshes But in order to get a proper comparison of the behavior of meshes in the inguinal region it is important to include the material and the pore size. The aim of our study is to compare patient-reported outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE) vs a small pore polypropylene mesh (SP-PPL).
Detailed Description
Patients fitted for laparoscopic bilateral inguinal hernia repair will be randomized to recieve one of both meshes on study in both inguinal sides.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LP PTFE
Arm Type
Experimental
Arm Description
Placement of Large Pore PTFE mesh for inguinal hernia treatment
Arm Title
SP-PPL
Arm Type
Active Comparator
Arm Description
Placement of Small Pore polypropylene mesh for inguinal hernia treatment
Intervention Type
Procedure
Intervention Name(s)
Totally Extraperitoneal laparoscopic inguinal hernia repair
Other Intervention Name(s)
TEP
Intervention Description
Laparoscopic hernioplasty
Primary Outcome Measure Information:
Title
Postoperative Discomfort
Description
Postoperative Discomfort in the inguinal area is assessed using a visual analog scale (VAS)on the first 12 postoperative months.
Discomfort is defined as a disturbing sensation without influencing normal activities of the patient
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
Postoperative pain in the inguinal area is assessed using a visual analog scale (VAS)on the first 12 postoperative months.
Pain is described as an unpleasant sensation that interferes with the normal activities of the patient
Time Frame
1 year
Title
Recurrence
Description
Reappearance of a inguinal hernia in a previous operated inguinal hernia.
Time Frame
1 year
Title
Postoperative complications
Description
Complications such as seroma or haematoma in groin area.
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male patients
20-80 years old
Primary Bilateral Hernia
Exclusion Criteria:
Women
BMI >35
Recurrent hernias
Previous infraumbilical laparotomy
Inguinoscrotal hernias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvador Morales-Conde, PhD
Organizational Affiliation
Hospital Universitario Virgen del Rocio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isaias Alarcón, PhD
Organizational Affiliation
Hospital Universitario Virgen del Rocio
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocio
City
Seville
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22575883
Citation
Pascual G, Hernandez-Gascon B, Rodriguez M, Sotomayor S, Pena E, Calvo B, Bellon JM. The long-term behavior of lightweight and heavyweight meshes used to repair abdominal wall defects is determined by the host tissue repair process provoked by the mesh. Surgery. 2012 Nov;152(5):886-95. doi: 10.1016/j.surg.2012.03.009. Epub 2012 May 8.
Results Reference
background
PubMed Identifier
21989559
Citation
Jacob DA, Schug-Pass C, Sommerer F, Tannapfel A, Lippert H, Kockerling F. Comparison of a lightweight polypropylene mesh (Optilene(R) LP) and a large-pore knitted PTFE mesh (GORE(R) INFINIT(R) mesh)--Biocompatibility in a standardized endoscopic extraperitoneal hernia model. Langenbecks Arch Surg. 2012 Feb;397(2):283-9. doi: 10.1007/s00423-011-0858-8. Epub 2011 Oct 12.
Results Reference
background
PubMed Identifier
21279663
Citation
Melman L, Jenkins ED, Hamilton NA, Bender LC, Brodt MD, Deeken CR, Greco SC, Frisella MM, Matthews BD. Histologic and biomechanical evaluation of a novel macroporous polytetrafluoroethylene knit mesh compared to lightweight and heavyweight polypropylene mesh in a porcine model of ventral incisional hernia repair. Hernia. 2011 Aug;15(4):423-31. doi: 10.1007/s10029-011-0787-z. Epub 2011 Jan 30.
Results Reference
background
PubMed Identifier
32350735
Citation
Alarcon I, Balla A, Soler Frias JR, Barranco A, Bellido Luque J, Morales-Conde S. Polytetrafluoroethylene versus polypropylene mesh during laparoscopic totally extraperitoneal (TEP) repair of inguinal hernia: short- and long-term results of a double-blind clinical randomized controlled trial. Hernia. 2020 Oct;24(5):1011-1018. doi: 10.1007/s10029-020-02200-y. Epub 2020 Apr 30.
Results Reference
derived
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Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair
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