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

N

Nanchong Central Hospital

Status

Invitation-only

Conditions

Inguinal Hernia

Treatments

Procedure: 3D mesh Non-FIxation
Procedure: 3D Mesh Single-Suture Fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT06879860
2024156

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. primary inguinal hernia
  2. Type III inguinal hernia (internal annulus >3cm)

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

one-stitch fixation
Experimental group
Treatment:
Procedure: 3D Mesh Single-Suture Fixation
non-fixation
Active Comparator group
Treatment:
Procedure: 3D mesh Non-FIxation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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