Inguinal HerniaWire vs ProlenNCT05879770
Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
An observational study of Inguinal Hernia, run by Shouldice Hospital at 1 site in Canada.
Trial summary
When conducting the Shouldice procedure the 4-layer suture of the transversalis fascia is usually done with Prolene worldwide. At the Shouldice hospital the wire has originally been used for these augmentation. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- suture material
- How many people
- 1,400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Mar 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.
Who may be able to join
- Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.
Who cannot join
- Hernia repair using a mesh
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Shouldice Hospital
Thornhill, Ontario, L3T 4A3,
Marguerite Mainprize, MSc, 905-889-1125 ext. 1297, mmainprize@shouldice.com
Fernando Netto Spencer, PhD, 905-889-1125 ext. 1297, fspencernetto@shouldice.com
About this study
When conducting the Shouldice procedure the 4-layer suture of the transversalis fascia is usually done with Prolene worldwide. At the Shouldice hospital the wire has originally been used for these augmentation. During the last decade several Shouldice Surgeons started to use the Prolene due to occasional delivery problems of the wire from Germany.
The 1-year- recurrence rate at the Shouldice hospital is 1,15% (mainly wire-use). The published 1-year recurrence rate in Europe is 2%.
As quality assessment, this project intends to evaluate these two options for suturing (wire vs Prolene) in the elective inguinal hernia patient in terms of 1-year recurrence rate. The population of focus will be those who had a primary or secondary inguinal hernia operation at Shouldice Hospital and the project is estimated to take 3 months.
Read the detailed description
- Study design A total of 1400 patients (n=700 with wire; n=700 with Prolene) who underwent Shouldice surgery at Shouldice Hospital will be contacted by telephone. They will be asked whether a relapse occurred after their surgery.
Sample size calculation:
The 1-year recurrence rate at Shouldice Hospital is 1.15% (mainly wire use). The published 1-year recurrence rate in Europe is 2% [1-3]. Statistics: non-inferiority: delta for non-inferiority (defined equivalence range) = 1%. Total N = 1120 (0% dropout), with 20% dropout: N = 1400.) The same number of patients will be analyzed with regard to Shouldice repair due to a first relapse (time period of data extraction 2019-2021).
Since over 6000 hernias are operated annually, a consecutive data extraction of patients operated in 2021 will be performed.
- Conditions
- Inguinal Hernia
- Being tested
- suture material
- Keywords
- Hernia, Shouldice Repair, groin hernia
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suture materialOther
Some patients have had a shouldice repair with wire in the past and others with Prolene.
| Study group | Role | What they receive |
|---|---|---|
| Wire group | Patients who underwent Shouldice inguinal hernia repair using wire. Receives: Other: suture material | |
| prolene group | Patients who underwent Shouldice inguinal hernia repair using prolene. Receives: Other: suture material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
One-year recurrence rate
Measured: 1 year
Secondary outcomes (1)
Reoperation rate due to a recurrence
Reoperation rate due to a recurrence
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 posted30 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (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
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shouldice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879770
- Sponsor's protocol ID
- #2023-02
- Acronym
- Wire vs Prolen
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
- ClinicalTrials.gov ID
- NCT05879770
- Acronym / sponsor ID
- Wire vs Prolen / #2023-02
- Conditions
- Inguinal Hernia
- Keywords
- Hernia, Shouldice Repair, groin hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Shouldice HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 30 May 2023 (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.
When conducting the Shouldice procedure the 4-layer suture of the transversalis fascia is usually done with Prolene worldwide. At the Shouldice hospital the wire has originally been used for these augmentation. During the last decade several Shouldice Surgeons started to use the Prolene due to occasional delivery problems of the wire from Germany.
The 1-year- recurrence rate at the Shouldice hospital is 1,15% (mainly wire-use). The published 1-year recurrence rate in Europe is 2%.
As quality assessment, this project intends to evaluate these two options for suturing (wire vs Prolene) in the elective inguinal hernia patient in terms of 1-year recurrence rate. The population of focus will be those who had a primary or secondary inguinal hernia operation at Shouldice Hospital and the project is estimated to take 3 months.
Detailed description
- Study design A total of 1400 patients (n=700 with wire; n=700 with Prolene) who underwent Shouldice surgery at Shouldice Hospital will be contacted by telephone. They will be asked whether a relapse occurred after their surgery.
Sample size calculation:
The 1-year recurrence rate at Shouldice Hospital is 1.15% (mainly wire use). The published 1-year recurrence rate in Europe is 2% [1-3]. Statistics: non-inferiority: delta for non-inferiority (defined equivalence range) = 1%. Total N = 1120 (0% dropout), with 20% dropout: N = 1400.) The same number of patients will be analyzed with regard to Shouldice repair due to a first relapse (time period of data extraction 2019-2021).
Since over 6000 hernias are operated annually, a consecutive data extraction of patients operated in 2021 will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wire group | – | Other: suture materialPatients who underwent Shouldice inguinal hernia repair using wire. |
| prolene group | – | Other: suture materialPatients who underwent Shouldice inguinal hernia repair using prolene. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.
Key inclusion criteria (1 listed)
- Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.
Key exclusion criteria (1 listed)
- Hernia repair using a mesh
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 |
|---|---|---|
| suture materialSome patients have had a shouldice repair with wire in the past and others with Prolene. | Other | Wire group, prolene group |
Primary outcome
Recurrence rate
Time frame: 1 year
One-year recurrence rate
1 secondary outcome
Reoperation rate due to a recurrence
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 30 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Shouldice Hospital 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 30 May 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (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 30 May 2023.