Ilioinguinal Nerve SectionNCT06327763
Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair
A study testing ilioinguinal nerve section in people with Ilioinguinal Nerve Section and Pain Prevention, run by Zagazig University at 1 site in Egypt.
Trial summary
postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair. Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Read more about this study
- Who is it for?
- Ages 16 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ilioinguinal Nerve Section, Pain Prevention, Hernioplasty
- What is being tested?
- ilioinguinal nerve section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jun 2023
- 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 16 to 80 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- the study included all adult patients operated on for unilateral inguinal hernia by Lichtenstein tension-free mesh hernioplasty with or without ilioinguinal neurectomy.
Who cannot join
- patients with recurrent inguinal hernia, bilateral inguinal hernia repair, or huge inguinoscrotal hernia were excluded. Diabetic patients as well as, patients with suspected inguinal hernia recurrence at the time of the questionnaire were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair for Prevention of Chronic Postoperative Pain
postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.
Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia.
- Conditions
- Ilioinguinal Nerve Section, Pain Prevention, Hernioplasty
- Being tested
- ilioinguinal nerve section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ilioinguinal nerve sectionProcedure or surgery
patients operated on by open inguinal hernioplasty with ilioinguinal neurectomy
| Study group | Role | What they receive |
|---|---|---|
| inguinal hernioplasty with ilioinguinal nerve preservation | No intervention | Not described |
| inguinal hernioplasty with ilioinguinal nerve section | Experimental | Not described Receives: Procedure: ilioinguinal nerve section |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect postoperative pain using short form inguinal pain questionnaire
ask the patient for presence of postoperative pain using short form inguinal pain questionnaire
Measured: 3 months following operation then continous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ilioinguinal Nerve SectionStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yasser Ali Orban, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327763
- Sponsor's protocol ID
- Ilioinguinal Neurectomy
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Orban YA, Hegab YH, Hamed AEM, Metwally H, Zakaria R, Goda AM, Baz Y. Prophylactic triple neurectomy during open tension-free inguinal hernia repair: a clinical trial for the prevention of chronic postoperative pain. Updates Surg. 2026 Jan 22. doi: 10.1007/s13304-025-02497-3. Online ahead of print.
PubMed 41571965
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair for Prevention of Chronic Postoperative Pain
- ClinicalTrials.gov ID
- NCT06327763
- Acronym / sponsor ID
- Ilioinguinal Neurectomy
- Conditions
- Ilioinguinal Nerve Section, Pain Prevention, Hernioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 25 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.
postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.
Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inguinal hernioplasty with ilioinguinal nerve preservation | No intervention | – |
| inguinal hernioplasty with ilioinguinal nerve section | Experimental | Procedure: ilioinguinal nerve section |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the study included all adult patients operated on for unilateral inguinal hernia by Lichtenstein tension-free mesh hernioplasty with or without ilioinguinal neurectomy.
Key exclusion criteria (1 listed)
- patients with recurrent inguinal hernia, bilateral inguinal hernia repair, or huge inguinoscrotal hernia were excluded. Diabetic patients as well as, patients with suspected inguinal hernia recurrence at the time of the questionnaire were excluded.
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 |
|---|---|---|
| ilioinguinal nerve sectionpatients operated on by open inguinal hernioplasty with ilioinguinal neurectomy | Procedure or surgery | inguinal hernioplasty with ilioinguinal nerve section |
Primary outcome
detect postoperative pain using short form inguinal pain questionnaire
Time frame: 3 months following operation then continous
ask the patient for presence of postoperative pain using short form inguinal pain questionnaire
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 25 Mar 2024.
- Derived from this study: PubMed 41571965Orban YA, Hegab YH, Hamed AEM, Metwally H, Zakaria R, Goda AM, Baz Y. Prophylactic triple neurectomy during open tension-free inguinal hernia repair: a clinical trial for the prevention of chronic postoperative pain. Updates Surg. 2026 Jan 22. doi: 10.1007/s13304-025-02497-3. Online ahead of print.
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 ilioinguinal nerve section in people with Ilioinguinal Nerve Section and Pain Prevention, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 1 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 25 Mar 2024. 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 Egypt. 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?
detect postoperative pain using short form inguinal pain questionnaire (time frame: 3 months following operation then continous). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327763, which also lists 1 linked publication.
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 25 Mar 2024.