Inguinal HerniaPhase 2NCT00492804
Elective Neurectomy During Inguinal Hernia Repair
A Phase 2 study testing Lichtenstein hernia repair and Neurectomy in people with Inguinal Hernia, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair. It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein hernia repair and Neurectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2005to Sep 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uni- or bilateral inguinal hernia
- Karnofsky-index ≥70
- Informed consent
Who cannot join
- Recurrent inguinal hernia
- Previous inguinal operation
- Emergent operation
- Severe comorbidities
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Surgery, Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
About this study
Official title: Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial
Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.
It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.
This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein hernia repair, Neurectomy
- Keywords
- inguinal hernia, chronic pain, neurectomy, hypesthesia
- Medical subject headings
- Hernia, Inguinal, Chronic Pain, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein hernia repairProcedure or surgery
Lichtenstein hernia repair with tension free mesh
NeurectomyProcedure or surgery
Neurectomy
| Study group | Role | What they receive |
|---|---|---|
| Neurectomy | Other | Not described Receives: Procedure: Lichtenstein hernia repair; Procedure: Neurectomy |
| Nerve preservation | Other | Not described Receives: Procedure: Lichtenstein hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pain
Measured: up to three years
Secondary outcomes (4)
Incidence of hypesthesia or paraesthesia
Measured: one and three years
Recurrence rate
Measured: one and three years
Rate of intra- and postoperative complications
Measured: one and three years
Quality of life
Measured: one and three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJul 2005
- Primary completionMar 2011
- Study completionSep 2011
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Investigators
- Martin Thurnheer, MD, Principal investigator, Department of Surgery, Cantonal Hospital St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492804
- Sponsor's protocol ID
- 05/015/2B
- Status last verified
- Jan 2013
- First submitted
- 26 Jun 2007
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00492804
- Acronym / sponsor ID
- 05/015/2B
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, chronic pain, neurectomy, hypesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 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.
Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.
It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.
This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurectomy | Other | Procedure: Lichtenstein hernia repair, Procedure: Neurectomy |
| Nerve preservation | Other | Procedure: Lichtenstein hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Uni- or bilateral inguinal hernia
- Karnofsky-index ≥70
- Informed consent
Key exclusion criteria (4 listed)
- Recurrent inguinal hernia
- Previous inguinal operation
- Emergent operation
- Severe comorbidities
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 |
|---|---|---|
| Lichtenstein hernia repairLichtenstein hernia repair with tension free mesh | Procedure or surgery | Nerve preservation, Neurectomy |
| NeurectomyNeurectomy | Procedure or surgery | Neurectomy |
Primary outcome
Incidence of postoperative pain
Time frame: up to three years
4 secondary outcomes
Incidence of hypesthesia or paraesthesia
Time frame: one and three years
Recurrence rate
Time frame: one and three years
Rate of intra- and postoperative complications
Time frame: one and three years
Quality of life
Time frame: one and three years
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 28 Jan 2013.
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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.
Martin Thurnheer, MD principal investigator
Department of Surgery, Cantonal Hospital St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lichtenstein hernia repair and Neurectomy in people with Inguinal Hernia, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 28 Jan 2013. 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 Switzerland. 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.
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?
Incidence of postoperative pain (time frame: up to three years). 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 28 Jan 2013.