Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair (PTFE)

December 23, 2013 updated by: Salvador Morales Conde, Hospitales Universitarios Virgen del Rocío

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LP PTFE
Placement of Large Pore PTFE mesh for inguinal hernia treatment
Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repair
Laparoscopic hernioplasty
Other Names:
  • TEP
ACTIVE_COMPARATOR: SP-PPL
Placement of Small Pore polypropylene mesh for inguinal hernia treatment
Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repair
Laparoscopic hernioplasty
Other Names:
  • TEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
Recurrence
Time Frame: 1 year
Reappearance of a inguinal hernia in a previous operated inguinal hernia.
1 year
Postoperative complications
Time Frame: 1 year
Complications such as seroma or haematoma in groin area.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitales Universitarios Virgen del Rocío

Investigators

  • Principal Investigator: Salvador Morales-Conde, PhD, Hospital Universitario Virgen del Rocio
  • Study Chair: Isaias Alarcón, PhD, Hospital Universitario Virgen del Rocio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (ESTIMATE)

December 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP-PTFE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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