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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06879860

Enrollment

150

Registered

2025-03-17

Start date

2024-08-01

Completion date

2028-12-31

Last updated

2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

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.

Interventions

PROCEDURE3D Mesh Single-Suture Fixation

3D mesh fixation in 1 points

PROCEDURE3D mesh Non-FIxation

3D mesh fixation with non-flxation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of recurrence	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.
Rate of postoperative pain	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.

Secondary

Measure	Time frame	Description
Rate of postoperative complications	6 month	Including infection, seroma, hematoma

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026