Postoperative PainPhase 2NCT00500214
Ilioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial
A Phase 2 study testing elective ilioinguinal nerve excision in people with Postoperative Pain and Postoperative Hyposthesia, run by Shahid Beheshti University of Medical Sciences.
Trial summary
this study was designed to evaluate the effect of routine excision of the ilioinguinal nerve in an attempt to decrease the incidence of chronic inguinodynia in patients who undergo open anterior hernia mesh repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Hyposthesia
- What is being tested?
- elective ilioinguinal nerve excision
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having an age of over 18 years
Who cannot join
- Those with diabetes, incarcerated, bilateral and recurrent hernias and visual problems were excluded from the investigation.
About this study
this study was designed to evaluate the effect of routine excision of the ilioinguinal nerve in an attempt to decrease the incidence of chronic inguinodynia in patients who undergo open anterior hernia mesh repair.
Read the detailed description
As chronic pain is the 2nd most common complication following open hernia repairs and it causes limitations and dysfunctions for the patients and also according to some previous studies elective ilioinguinal neurectomy could result in less postoperative pain,we decided to perform a randomized double blind clinical trial.The primary goal of this study was evaluation of the effect of this type of neurectomy on postoperative pain and hyposthesia.
- Conditions
- Postoperative Pain, Postoperative Hyposthesia
- Being tested
- elective ilioinguinal nerve excision
- Keywords
- inguinal hernia, herniorrhaphy, mesh repair, ilioinguinal neurectomy, postoperative pain in cases and controls during one year., postoperative hyposthesia in cases and controls during one year.
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective ilioinguinal nerve excisionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain using VAS (visual analogue scale)
Measured: 1 year
Secondary outcomes (1)
postoperative hyposthesia using VAS (visual analogue scale)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startApr 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- fatemeh malekpour, MD, Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500214
- Sponsor's protocol ID
- Ilioinguinal nerve excision
- Status last verified
- Jul 2007
- First submitted
- 10 Jul 2007
- Last updated
- 12 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ilioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00500214
- Acronym / sponsor ID
- Ilioinguinal nerve excision
- Conditions
- Postoperative Pain, Postoperative Hyposthesia
- Keywords
- inguinal hernia, herniorrhaphy, mesh repair, ilioinguinal neurectomy, postoperative pain in cases and controls during one year., postoperative hyposthesia in cases and controls during one year.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 12 Jul 2007 (estimated)
- 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 evaluate the effect of routine excision of the ilioinguinal nerve in an attempt to decrease the incidence of chronic inguinodynia in patients who undergo open anterior hernia mesh repair.
Detailed description
As chronic pain is the 2nd most common complication following open hernia repairs and it causes limitations and dysfunctions for the patients and also according to some previous studies elective ilioinguinal neurectomy could result in less postoperative pain,we decided to perform a randomized double blind clinical trial.The primary goal of this study was evaluation of the effect of this type of neurectomy on postoperative pain and hyposthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having an age of over 18 years
Key exclusion criteria (1 listed)
- Those with diabetes, incarcerated, bilateral and recurrent hernias and visual problems were excluded from the investigation.
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 |
|---|---|---|
| elective ilioinguinal nerve excision | Procedure or surgery | – |
Primary outcome
postoperative pain using VAS (visual analogue scale)
Time frame: 1 year
1 secondary outcome
postoperative hyposthesia using VAS (visual analogue scale)
Time frame: 1 year
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 12 Jul 2007.
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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.
fatemeh malekpour, MD principal investigator
Shahid Beheshti University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing elective ilioinguinal nerve excision in people with Postoperative Pain and Postoperative Hyposthesia, run by Shahid Beheshti University of Medical Sciences.
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 12 Jul 2007. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative pain using VAS (visual analogue scale) (time frame: 1 year). 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 12 Jul 2007.