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Enrolling by invitation NCT06879860

The Impact of 3D Patch One-Suture Fixation vs No Fixation on Chronic Pain and Recurrence in Ⅲ Inguinal Hernia

No phase Interventional Inguinal Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D Mesh Single-Suture Fixation, 3D mesh Non-FIxation.
Who it may be relevant to
Registry conditions: Inguinal Hernia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of 3D Patch Fixation With One Suture Versus no Fixation on Chronic Pain and Recurrence in Patients With Ⅲ Type Inguinal Hernia: A Multicenter Randomized Controlled Trial

Overview

This study aims to compare the effects of one-stitch fixation and non-fixation of 3D patches on chronic pain and recurrence in type III inguinal hernia. The primary outcome measures include hernia recurrence, chronic pain, etc.

Interventions

  • Procedure 3D Mesh Single-Suture Fixation
    3D mesh fixation in 1 points
  • Procedure 3D mesh Non-FIxation
    3D mesh fixation with non-flxation

Primary outcome measures

  • Rate of recurrence [Time frame: 1 month,3 months,6 months and 12 months after surgery]
  • Rate of postoperative pain [Time frame: 6 month]
Secondary outcome measures (1)
  • Rate of postoperative complications [Time frame: 6 month]

Eligibility criteria

Inclusion criteria

  • primary inguinal hernia
  • Type III inguinal hernia (internal annulus >3cm)

Exclusion criteria

  • Age below 18 years or older than 80. recurrent hernia, incarcerated hernia,strangulated hernia, and other types of hernias.
  • Patients not suitable for general anesthesia.
  • Patients requiring open surgery.
  • patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanchong Central Hospital — Nanchong

Identifiers

NCT: NCT06879860 · 2024156

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗