Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair

Not Applicable

Completed

• Conditions: Hernia, Inguinal
• Interventions: Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repair

• Registration Number: NCT02023203
• Lead Sponsor: Hospitales Universitarios Virgen del Rocío

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-10
• Study Completion: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-23
• Last Update Submitted: 2013-12-23
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LP PTFE	Totally Extraperitoneal laparoscopic inguinal hernia repair	Placement of Large Pore PTFE mesh for inguinal hernia treatment
SP-PPL	Totally Extraperitoneal laparoscopic inguinal hernia repair	Placement of Small Pore polypropylene mesh for inguinal hernia treatment

Primary Outcome Measures

Name	Time	Method
Postoperative Discomfort	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 Outcome Measures

Name	Time	Method
Postoperative Pain	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
Recurrence	1 year	Reappearance of a inguinal hernia in a previous operated inguinal hernia.
Postoperative complications	1 year	Complications such as seroma or haematoma in groin area.

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocio; 🇪🇸 Seville, Spain