The Impact of 3D Patch One-Suture Fixation vs No Fixation... | NCT06879860

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

NCT06879860

Sponsor

Nanchong Central Hospital

Status

Enrolling by invitation

Last Update Posted

Mar 31, 2026Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

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

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Mar 11, 2025

First Posted Date

Mar 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2026

Last Update Posted Date

Mar 31, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one-stitch fixation	Experimental		Procedure: 3D Mesh Single-Suture Fixation
non-fixation	Active Comparator		Procedure: 3D mesh Non-FIxation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D Mesh Single-Suture Fixation	Procedure	3D mesh fixation in 1 points	one-stitch fixation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanchong Central Hospital		Nanchong	Sichuan	637000	China

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided