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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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one-stitch fixation

Group Type EXPERIMENTAL

3D Mesh Single-Suture Fixation

Intervention Type PROCEDURE

3D mesh fixation in 1 points

non-fixation

Group Type ACTIVE_COMPARATOR

3D mesh Non-FIxation

Intervention Type PROCEDURE

3D mesh fixation with non-flxation

Interventions

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3D Mesh Single-Suture Fixation

3D mesh fixation in 1 points

Intervention Type PROCEDURE

3D mesh Non-FIxation

3D mesh fixation with non-flxation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No