Hernia, InguinalNCT05929378
A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III Inguinal Hernia
A study testing Lightweight mesh fixation in people with Hernia, Inguinal 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 type Ⅲ gilbert 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
- Hernia, Inguinal, Chronic Pain, Seroma
- What is being tested?
- Lightweight mesh fixation
- 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 30 Jan 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 indirect inguinal hernia according to preoperative physical examination and imaging examination.
- The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)
Who cannot join
- Age below 18 years or older than 80. Direct hernia, femoral hernia, 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 Surgery for Patients With Gilbert Type III Inguinal Hernia: A Randomized Controlled Trial
This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.
- Conditions
- Hernia, Inguinal, Chronic Pain, Seroma, Recurrence, Infections, Hematoma
- Being tested
- Lightweight mesh fixation
- 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 fixationProcedure or surgery
Lightweight mesh fixation in 3 points
| Study group | Role | What they receive |
|---|---|---|
| 3-point fixation group | Experimental | Lightweight Mesh Fixation with 3-point Fixation. First fixation is in cooper ligament. Second fixation is in the back of rectus abdominis. Third fixation is in the later of tractus iliopubicus. Receives: Procedure: Lightweight mesh fixation |
| 1-point fixation group | Active comparator | Lightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis. Receives: Procedure: Lightweight mesh fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Check for recurrence by clinical examination or ultrasound at 6 months postoperatively
Measured: 6 months
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 months
Secondary outcomes (1)
postoperative complications
Including infection, seroma, hematoma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jan 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies 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, Nanchong Jialing District People's Hospital, Langzhong People's Hospital, Langzhong Traditional Chinese Medicine Hospital
- Responsible party
- Principal investigator, Yunhong Tian, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929378
- Sponsor's protocol ID
- 2023031
- Status last verified
- May 2025
- First submitted
- 17 Jun 2023
- Last updated
- 21 May 2025
- 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 21 May 2025. 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 Surgery for Patients With Gilbert Type III Inguinal Hernia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05929378
- Acronym / sponsor ID
- 2023031
- Conditions
- Hernia, Inguinal, Chronic Pain, Seroma, Recurrence, 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, Nanchong Jialing District People's Hospital, Langzhong People's Hospital, Langzhong Traditional Chinese Medicine Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 3 Jul 2023 (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 type Ⅲ gilbert 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 fixationLightweight Mesh Fixation with 3-point Fixation. First fixation is in cooper ligament. Second fixation is in the back of rectus abdominis. Third fixation is in the later of tractus iliopubicus. |
| 1-point fixation group | Active comparator | Procedure: Lightweight mesh fixationLightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis. |
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 indirect inguinal hernia according to preoperative physical examination and imaging examination.
- The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)
Key exclusion criteria (2 listed)
- Age below 18 years or older than 80. Direct hernia, femoral hernia, 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 fixationLightweight mesh fixation in 3 points | Procedure or surgery | 1-point fixation group, 3-point fixation group |
Primary outcome
recurrence
Time frame: 6 months
Check for recurrence by clinical examination or ultrasound at 6 months postoperatively
Postoperative pain
Time frame: 6 months
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
postoperative complications
Time frame: 6 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 21 May 2025.
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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 people with Hernia, Inguinal 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 21 May 2025. 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?
recurrence (time frame: 6 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 21 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.