Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair
NCT ID: NCT02023203
Last Updated: 2013-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2011-01-31
2013-08-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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LP PTFE
Placement of Large Pore PTFE mesh for inguinal hernia treatment
Totally Extraperitoneal laparoscopic inguinal hernia repair
Laparoscopic hernioplasty
SP-PPL
Placement of Small Pore polypropylene mesh for inguinal hernia treatment
Totally Extraperitoneal laparoscopic inguinal hernia repair
Laparoscopic hernioplasty
Interventions
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Totally Extraperitoneal laparoscopic inguinal hernia repair
Laparoscopic hernioplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 20-80 years old
* Primary Bilateral Hernia
Exclusion Criteria
* BMI \>35
* Recurrent hernias
* Previous infraumbilical laparotomy
* Inguinoscrotal hernias
20 Years
80 Years
MALE
No
Sponsors
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Hospitales Universitarios Virgen del Rocío
OTHER
Responsible Party
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Salvador Morales Conde
Innovation and Minimally Invasive Surgery Unit Cordinator
Principal Investigators
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Salvador Morales-Conde, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen del Rocio
Isaias Alarcón, PhD
Role: STUDY_CHAIR
Hospital Universitario Virgen del Rocio
Locations
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Hospital Universitario Virgen del Rocio
Seville, Seville, Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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LP-PTFE
Identifier Type: -
Identifier Source: org_study_id