Inguinal HerniaNCT07210424
Comparative Study on the Post-operative Pain and Other Outcomes of Mesh Fixation With Prolene vs Vicryl vs Skin Staples in Lichtenstein Inguinal Hernia Repair.
An observational study of Inguinal Hernia, run by King Edward Medical University.
Trial summary
We are going to see the outcome measures for patient and compare them across two groups, those who are undergoing mesh fixation for inguinal hernia by sutures, and those who are fixated by skin staples. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Mesh Fixation
- Type of treatment
- Surgery or procedure
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 29 Dec 2025to 28 Feb 2026
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with inguinal hernia undergoing mesh hernioplasty
Who may be able to join
- Patients undergoing inguinal hernia repair
- 18-65 years
- Both genders
Who cannot join
- COPD
- Immunocompromised
- Obstructive Uropathy
- Chronic constipation
About this study
We are going to see the outcome measures for patient and compare them across two groups, those who are undergoing mesh fixation for inguinal hernia by sutures, and those who are fixated by skin staples.
- Conditions
- Inguinal Hernia
- Being tested
- Mesh 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.
Mesh FixationProcedure or surgery
Mesh fixation during Lichtenstein inguinal hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Skin Staples | Mesh fixation by skin staples Receives: Procedure: Mesh Fixation | |
| Sutures | Mesh fixation by sutures (vicryl and prolene) Receives: Procedure: Mesh Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Pain scores at 3, 7, 14 and 30 days using a Visual Analogue Pain Scale with values ranging between 0 to 10, 0 meaning no pain and 10 being the highest level of pain.
Measured: At 3, 7, 14 and 30 post op day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start29 Dec 2025 (estimated)
- Primary completion29 Jan 2026 (estimated)
- Study completion28 Feb 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210424
- Sponsor's protocol ID
- 511/RC/KEMU
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Post-operative Pain and Other Outcomes of Mesh Fixation With Prolene vs Vicryl vs Skin Staples in Lichtenstein Inguinal Hernia Repair.
- ClinicalTrials.gov ID
- NCT07210424
- Acronym / sponsor ID
- 511/RC/KEMU
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 29 Dec 2025 (estimated)
- Primary completion
- 29 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Oct 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.
We are going to see the outcome measures for patient and compare them across two groups, those who are undergoing mesh fixation for inguinal hernia by sutures, and those who are fixated by skin staples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Staples | – | Procedure: Mesh FixationMesh fixation by skin staples |
| Sutures | – | Procedure: Mesh FixationMesh fixation by sutures (vicryl and prolene) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with inguinal hernia undergoing mesh hernioplasty
Key inclusion criteria (3 listed)
- Patients undergoing inguinal hernia repair
- 18-65 years
- Both genders
Key exclusion criteria (4 listed)
- COPD
- Immunocompromised
- Obstructive Uropathy
- Chronic constipation
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 |
|---|---|---|
| Mesh FixationMesh fixation during Lichtenstein inguinal hernia repair. | Procedure or surgery | Skin Staples, Sutures |
Primary outcome
Post Operative Pain
Time frame: At 3, 7, 14 and 30 post op day
Pain scores at 3, 7, 14 and 30 days using a Visual Analogue Pain Scale with values ranging between 0 to 10, 0 meaning no pain and 10 being the highest level of pain.
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by King Edward Medical University.
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 3 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: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Post Operative Pain (time frame: At 3, 7, 14 and 30 post op day). 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 17 Dec 2025.