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Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair

Prospective Randomized Clinical Trial Comparing Microporous Polypropylene Mesh and Flexible Macroporous Polytetrafluoroethylene Mesh in Totally Extraperitoneal Laparoscopic Inguinal Hernia Repair

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02023203
Acronym
PTFE
Enrollment
100
Registered
2013-12-30
Start date
2011-01-31
Completion date
2013-08-31
Last updated
2013-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

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.

Interventions

Sponsors

Hospitales Universitarios Virgen del Rocío
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* male patients * 20-80 years old * Primary Bilateral Hernia

Exclusion criteria

* Women * BMI \>35 * Recurrent hernias * Previous infraumbilical laparotomy * Inguinoscrotal hernias

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Discomfort1 yearPostoperative 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

MeasureTime frameDescription
Postoperative Pain1 yearPostoperative 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
Recurrence1 yearReappearance of a inguinal hernia in a previous operated inguinal hernia.
Postoperative complications1 yearComplications such as seroma or haematoma in groin area.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026