Inguinal HerniaNCT06314152
3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
A study testing Lightweight mesh fixation in 3 points or 1 point in people with Inguinal Hernia and Chronic Pain, run by Nanchong Central Hospital at 1 site in China.
Trial summary
This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia, Chronic Pain, Seroma
- What is being tested?
- Lightweight mesh fixation in 3 points or 1 point
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Unilateral inguinal hernia according to preoperative physical examination and imaging examination.
- The inclusion criteria were as follows: primary inguinal hernia.
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.
About this study
Official title: A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.
- Conditions
- Inguinal Hernia, Chronic Pain, Seroma, Recurrent, Infections, Hematoma
- Being tested
- Lightweight mesh fixation in 3 points or 1 point
- Medical subject headings
- Hernia, Inguinal, Chronic Pain, Seroma, Recurrence, Infections, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lightweight mesh fixation in 3 points or 1 pointProcedure or surgery
Lightweight mesh fixation in 3 points
| Study group | Role | What they receive |
|---|---|---|
| 3-point fixation group | Experimental | Using 3-0 absorbable sutures, the mesh was secured at three key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, and (3) the lateral edge of the iliopubic tract. Receives: Procedure: Lightweight mesh fixation in 3 points or 1 point |
| 1-point fixation group | Active comparator | Using 3-0 absorbable sutures, the mesh was secured at one of the following key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, or (3) the lateral edge of the iliopubic tract. The fixation site was selected based on the most prominent anatomical landmark, with preference given to the pubic pectineal ligament (Cooper's ligament) or the lateral edge of the iliopubic tract. Receives: Procedure: Lightweight mesh fixation in 3 points or 1 point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative pain
The visual analog scale (VAS) was adopted for pain evaluation 1 day, 7 days, 1 month, 3 months, 6 months and 12 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.
Measured: 12 months
Rate of recurrence
Hernia recurrenceFollow 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
Secondary outcomes (1)
Rate of postoperative complications
Including infection, seroma, hematoma
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
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
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Collaborators
- Guang'an people's hospital of Sichuan province, Pengan County People's Hospital, People's Hospital of Yilong County, Nanbu Hospital of County Chinese Medicine, Langzhong People's Hospital, Langzhong Traditional Chinese Medicine Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314152
- Sponsor's protocol ID
- 2023032
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
- ClinicalTrials.gov ID
- NCT06314152
- Acronym / sponsor ID
- 2023032
- Conditions
- Inguinal Hernia, Chronic Pain, Seroma, Recurrent, Infections, Hematoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Nanchong Central HospitalOther government
- Collaborators
- Guang'an people's hospital of Sichuan province, Pengan County People's Hospital, People's Hospital of Yilong County, Nanbu Hospital of County Chinese Medicine, Langzhong People's Hospital, Langzhong Traditional Chinese Medicine Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 15 Mar 2024 (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 was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-point fixation group | Experimental | Procedure: Lightweight mesh fixation in 3 points or 1 pointUsing 3-0 absorbable sutures, the mesh was secured at three key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, and (3) the lateral edge of the iliopubic tract. |
| 1-point fixation group | Active comparator | Procedure: Lightweight mesh fixation in 3 points or 1 pointUsing 3-0 absorbable sutures, the mesh was secured at one of the following key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, or (3) the lateral edge of the iliopubic tract. The fixation site was selected based on the most prominent anatomical landmark, with preference given to the pubic pectineal ligament (Cooper's ligament) or the lateral edge of the iliopubic tract. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral inguinal hernia according to preoperative physical examination and imaging examination.
- The inclusion criteria were as follows: primary inguinal hernia.
Key exclusion criteria (2 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 |
|---|---|---|
| Lightweight mesh fixation in 3 points or 1 pointLightweight mesh fixation in 3 points | Procedure or surgery | 1-point fixation group, 3-point fixation group |
Primary outcome
Rate of postoperative pain
Time frame: 12 months
The visual analog scale (VAS) was adopted for pain evaluation 1 day, 7 days, 1 month, 3 months, 6 months and 12 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.
Rate of recurrence
Time frame: 1 month,3 months,6 months and 12 months after surgery
Hernia recurrenceFollow 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 secondary outcome
Rate of postoperative complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Lightweight mesh fixation in 3 points or 1 point in people with Inguinal Hernia and Chronic Pain, 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 2 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: finished, as of the sponsor's last update on 9 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 postoperative pain (time frame: 12 months). 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 9 Apr 2026.