Inguinal HerniaNCT06879860
The Impact of 3D Patch One-Suture Fixation vs No Fixation on Chronic Pain and Recurrence in Ⅲ Inguinal Hernia
A study testing 3D Mesh Single-Suture Fixation and 3D mesh Non-FIxation in people with Inguinal Hernia, run by Nanchong Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- 3D Mesh Single-Suture Fixation and 3D mesh Non-FIxation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary inguinal hernia
- Type III inguinal hernia (internal annulus >3cm)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- Inguinal Hernia
- Being tested
- 3D Mesh Single-Suture Fixation, 3D mesh Non-FIxation
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Mesh Single-Suture FixationProcedure or surgery
3D mesh fixation in 1 points
3D mesh Non-FIxationProcedure or surgery
3D mesh fixation with non-flxation
| Study group | Role | What they receive |
|---|---|---|
| one-stitch fixation | Experimental | Not described Receives: Procedure: 3D Mesh Single-Suture Fixation |
| non-fixation | Active comparator | Not described Receives: Procedure: 3D mesh Non-FIxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 month
Secondary outcomes (1)
Rate of postoperative complications
Including infection, seroma, hematoma
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Aug 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879860
- Sponsor's protocol ID
- 2024156
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06879860
- Acronym / sponsor ID
- 2024156
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-stitch fixation | Experimental | Procedure: 3D Mesh Single-Suture Fixation |
| non-fixation | Active comparator | Procedure: 3D mesh Non-FIxation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary inguinal hernia
- Type III inguinal hernia (internal annulus >3cm)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Mesh Single-Suture Fixation3D mesh fixation in 1 points | Procedure or surgery | one-stitch fixation |
| 3D mesh Non-FIxation3D mesh fixation with non-flxation | Procedure or surgery | non-fixation |
Primary outcome
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.
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.
1 secondary outcome
Rate of postoperative complications
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Mesh Single-Suture Fixation and 3D mesh Non-FIxation in people with Inguinal Hernia, run by Nanchong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence (time frame: 1 month,3 months,6 months and 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.