Inguinal HerniaNCT01391455
Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair
A study testing Isolation of the spermatic cord from mesh in people with Inguinal Hernia, run by Chatham Kent Health Alliance at 1 site in Canada.
Trial summary
There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Isolation of the spermatic cord from mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Aug 2013
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of a primary unilateral inguinal hernia
Who cannot join
- Medically unfit for surgical repair
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Chatham Kent Health Alliance
Chatham, Ontario
John A Morrison, MD;FRCS(C), 519 352 0503, hernia@johnmorrisonmd.com
Gary Tithecott, MD;FRCP(C), 519 3526400, gtithecott@ckha.on.ca
About this study
Official title: Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair
There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. This can lead to a severe degradation of the patient's lifestyle, work habits and sexual function. The origin of the pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also involves the spermatic cord and its structures, leading to orchidinia and possibly azospermia.
Read the detailed description
In this prospective randomized trial, male patients with a primary symptomatic unilateral inguinal hernia will be admitted to the trial. All patients must be over 21 years of age. In order to avoid inguinal nerve entrapment or damage by mesh fixation sutures Covidien Parietene ProGrip mesh will be employed. This mesh does not require fixation. Standard open inguinal hernia repair will take place with nerve preservation, as day surgery cases. In the randomized portion of the study, the mesh will be placed as usual along the posterior wall of the inguinal canal, however the inguinal ligament will be interposed between the mesh and the spermatic cord, thus isolating the cord from intimate contact with the mesh, and a reduction in postoperative inflammatory changes.
- Conditions
- Inguinal Hernia
- Being tested
- Isolation of the spermatic cord from mesh
- Keywords
- Inguinal hernia repair, Mesh, Groin pain, Testicular pain
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of the spermatic cord from meshProcedure or surgery
The spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair.
| Study group | Role | What they receive |
|---|---|---|
| Spermatic Cord in contact with mesh | No intervention | Where the spermatic cord has been allowed to remain in contact with the mesh. |
| Spermatic Cord is isolated from the mesh | Experimental | The inguinal ligament is interposed between the cord and the mesh and then repaired. This isolates the cord from the mesh and the splinting function of the overlying inguinal ligament. Receives: Procedure: Isolation of the spermatic cord from mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.
All patients will be evaluated using the Carolina's Comfort Scale
Measured: 1 year postoperatively
Secondary outcomes (1)
Number of patients with adverse events.
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 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2013 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chatham Kent Health Alliance
- Sponsor type
- University, hospital or other
- Investigators
- John A Morrison, MD;FRCS(C), Principal investigator, Chatham Kent Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391455
- Sponsor's protocol ID
- mesh isolation
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01391455
- Acronym / sponsor ID
- mesh isolation
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia repair, Mesh, Groin pain, Testicular pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chatham Kent Health AllianceUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 12 Jul 2011 (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.
There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. This can lead to a severe degradation of the patient's lifestyle, work habits and sexual function. The origin of the pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also involves the spermatic cord and its structures, leading to orchidinia and possibly azospermia.
Detailed description
In this prospective randomized trial, male patients with a primary symptomatic unilateral inguinal hernia will be admitted to the trial. All patients must be over 21 years of age. In order to avoid inguinal nerve entrapment or damage by mesh fixation sutures Covidien Parietene ProGrip mesh will be employed. This mesh does not require fixation. Standard open inguinal hernia repair will take place with nerve preservation, as day surgery cases. In the randomized portion of the study, the mesh will be placed as usual along the posterior wall of the inguinal canal, however the inguinal ligament will be interposed between the mesh and the spermatic cord, thus isolating the cord from intimate contact with the mesh, and a reduction in postoperative inflammatory changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spermatic Cord in contact with mesh | No intervention | –Where the spermatic cord has been allowed to remain in contact with the mesh. |
| Spermatic Cord is isolated from the mesh | Experimental | Procedure: Isolation of the spermatic cord from meshThe inguinal ligament is interposed between the cord and the mesh and then repaired. This isolates the cord from the mesh and the splinting function of the overlying inguinal ligament. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of a primary unilateral inguinal hernia
Key exclusion criteria (1 listed)
- Medically unfit for surgical repair
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 |
|---|---|---|
| Isolation of the spermatic cord from meshThe spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair. | Procedure or surgery | Spermatic Cord is isolated from the mesh |
Primary outcome
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.
Time frame: 1 year postoperatively
All patients will be evaluated using the Carolina's Comfort Scale
1 secondary outcome
Number of patients with adverse events.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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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.
John A Morrison, MD;FRCS(C) principal investigator
Chatham Kent Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolation of the spermatic cord from mesh in people with Inguinal Hernia, run by Chatham Kent Health Alliance at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 12 Jul 2011. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John A Morrison, MD; FRCS(C) (519 352 0503, hernia@johnmorrisonmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively. (time frame: 1 year postoperatively). 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 2011.