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OpenTrials
Completed

NCT Number: NCT02023203

Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair

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).

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Key information

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

About this study

Patients fitted for laparoscopic bilateral inguinal hernia repair will be randomized to recieve one of both meshes on study in both inguinal sides.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women
  • BMI >35
  • Recurrent hernias
  • Previous infraumbilical laparotomy
  • Inguinoscrotal hernias

Treatment and study plan

Totally extraperitoneal laparoscopic inguinal hernia repair

Procedure

Laparoscopic hernioplasty

Other names: TEP

Primary outcomes

  1. Postoperative Discomfort

    Time frame: 1 year

    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 outcomes

  1. Postoperative Pain

    Time frame: 1 year

    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

  2. Recurrence

    Time frame: 1 year

    Reappearance of a inguinal hernia in a previous operated inguinal hernia.

  3. Postoperative complications

    Time frame: 1 year

    Complications such as seroma or haematoma in groin area.

Sponsors and collaborators

Lead sponsor

Hospitales Universitarios Virgen del Rocío

Other

Registry information

Official study title

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

Acronym: PTFE

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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