NCT06879860

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Aug 2024Dec 2028

Study Start

First participant enrolled

August 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

March 11, 2025

Last Update Submit

March 29, 2026

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

  • Rate of recurrence

    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

    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 Outcomes (1)

  • Rate of postoperative complications

    6 month

Study Arms (2)

one-stitch fixation

EXPERIMENTAL
Procedure: 3D Mesh Single-Suture Fixation

non-fixation

ACTIVE COMPARATOR
Procedure: 3D mesh Non-FIxation

Interventions

3D Mesh Single-Suture FixationPROCEDURE

3D mesh fixation in 1 points

one-stitch fixation
3D mesh Non-FIxationPROCEDURE

3D mesh fixation with non-flxation

non-fixation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

August 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

CN(1)