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Comparative study between chronic post operative pain after using polypropylene mesh and self fixating mesh for management of primary inguinal hernia in adult males: a prospective randomized controlled trial

Comparative study between Lichtenstein procedure using polypropylene mesh and self fixating mesh for management of primary inguinal hernia in adult males in terms of chronic post operative pain: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001047684
Enrollment
90
Registered
2014-09-30
Start date
2014-10-26
Completion date
2015-11-04
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aft er the great invention of tension free mesh repair, criteria of success of inguinal hernia repair have changed. One of the most important parameters is chronic pain that begins after hernioplasty and persists aft er 3 months of the operation, with an incidence ranging from 1% to 19%. The aim of this study is to evaluate the self gripping mesh compared to standard polypropylene mesh in treating primary inguinal hernia in adult males in terms of chronic post operative pain.

Interventions

Lichtenstein procedure; semi-absorbable self fixating mesh “ParietexProgrip Trademark Mesh” (12X8 cm) is applied over the fascia transversalis after herniotomy and narrowing of the deep ring. For application of the mesh, anatomy around the spermatic cord should be clear. The flap of the mesh is opened and closed loosely around the spermatic cord. The mesh was presented with the self gripping surface facing the tissues. Mesh is applied from medial side exceeding one centimeter of the pubic bone f

Lichtenstein procedure; semi-absorbable self fixating mesh “ParietexProgrip Trademark Mesh” (12X8 cm) is applied over the fascia transversalis after herniotomy and narrowing of the deep ring. For application of the mesh, anatomy around the spermatic cord should be clear. The flap of the mesh is opened and closed loosely around the spermatic cord. The mesh was presented with the self gripping surface facing the tissues. Mesh is applied from medial side exceeding one centimeter of the pubic bone first then was spread on the surrounding tissue around the spermatic cord starting by spreading the cranial part and lastly fixing the lower part to inguinal ligament. No sutures were used for fixation of the mesh. Care was taken to avoid folding the mesh. Trimming small part of the mesh may be needed to achieve the non folding. We completed the procedure by closing the external spermatic fascia and the skin. Procedure duration is about (60 - 120 minutes)

Sponsors

King Khalid University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

male patients with primary inguinal hernia classified as Gilbert III or IV

Exclusion criteria

patients with complicated hernia, and or with persistant predisposing factor of hernia (chronic cough or ascites,...etc) that could not be treated preoperatively

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026