Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair

NCT02023203 | Completed

• 1 other identifier: LP-PTFE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• Postoperative Discomfort

  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 Outcomes (3)

• Postoperative Pain

  1 year

• Recurrence

  1 year

• Postoperative complications

  1 year

Study Arms (2)

LP PTFE

EXPERIMENTAL

Placement of Large Pore PTFE mesh for inguinal hernia treatment

Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repair

SP-PPL

ACTIVE COMPARATOR

Placement of Small Pore polypropylene mesh for inguinal hernia treatment

Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repair

Interventions

Totally Extraperitoneal laparoscopic inguinal hernia repair PROCEDURE

Laparoscopic hernioplasty

Also known as: TEP

LP PTFE; SP-PPL

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male patients
• years old
• Primary Bilateral Hernia

You may not qualify if:

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

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, Seville, 41013, Spain

Location

Related Publications (4)

• 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.

  PMID: 22575883 BACKGROUND

• 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.

  PMID: 21989559 BACKGROUND

• 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.

  PMID: 21279663 BACKGROUND

• 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.

  PMID: 32350735 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvador Morales-Conde, PhD

  Hospital Universitario Virgen del Rocio

  PRINCIPAL INVESTIGATOR

• Isaias Alarcón, PhD

  Hospital Universitario Virgen del Rocio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Innovation and Minimally Invasive Surgery Unit Cordinator

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: August 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

ES (1)