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

March 29, 2026 updated by: Nanchong Central Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Nanchong Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one-stitch fixation
Procedure: 3D Mesh Single-Suture Fixation
3D mesh fixation in 1 points
Active Comparator: non-fixation
Procedure: 3D mesh Non-FIxation
3D mesh fixation with non-flxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrence
Time Frame: 1 month,3 months,6 months and 12 months after surgery
Hernia recurrence Follow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence.
1 month,3 months,6 months and 12 months after surgery
Rate of postoperative pain
Time Frame: 6 month
The visual analog scale (VAS) was adopted for pain evaluation 2 days, 3 months, and 6 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative complications
Time Frame: 6 month
Including infection, seroma, hematoma
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanchong Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024156

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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