Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair

Hernia, Inguinal Clinical Trial

— PTFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023203
• Other study ID #: LP-PTFE
• Status: Completed
• Phase: N/A
• First received: December 13, 2013
• Last updated: December 23, 2013
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Coordinador de Ética de la Investigación Biomédica de Andalucía
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Totally Extraperitoneal laparoscopic inguinal hernia repair
Laparoscopic hernioplasty

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocio	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Jacob DA, Schug-Pass C, Sommerer F, Tannapfel A, Lippert H, Köckerling F. Comparison of a lightweight polypropylene mesh (Optilene® LP) and a large-pore knitted PTFE mesh (GORE® INFINIT® 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. — View Citation

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. — View Citation

Pascual G, Hernández-Gascón B, Rodríguez M, Sotomayor S, Peña E, Calvo B, Bellón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Postoperative Pain	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	Yes
Secondary	Recurrence	Reappearance of a inguinal hernia in a previous operated inguinal hernia.	1 year	Yes
Secondary	Postoperative complications	Complications such as seroma or haematoma in groin area.	1 year	Yes