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Enrolling by Invitation

NCT Number: NCT06879860

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

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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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D Mesh Single-Suture Fixation

Procedure

3D mesh fixation in 1 points

3D mesh Non-FIxation

Procedure

3D mesh fixation with non-flxation

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Rate of postoperative complications

    Time frame: 6 month

    Including infection, seroma, hematoma

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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