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NCT05879770: Wire vs Prolen
Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
trial testing suture material in Inguinal Hernia in 1,400 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Shouldice Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,400 |
| Start date | 1 September 2023 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- suture material
Conditions studied
- Inguinal Hernia — all drugs for Inguinal Hernia →
Sponsor
Shouldice Hospital
Who can join
16 and older, any sex, with Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05879770
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of suture material
Trials testing the same drug.
- NCT03754907 — Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia · NA · unknown
Other recruiting trials for Inguinal Hernia
Currently open trials in the same condition.
- NCT07473687 — Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room · recruiting
- NCT06915155 — Swing-Mesh™ Study (SMS). · active not recruiting
- NCT07346742 — Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and · NA · recruiting
- NCT06871605 — Transversalis Fascia Plane vs Ilioinguinal and Iliohypogastric Nerve Block for the Treatment of CPIP · NA · recruiting
- NCT04706026 — A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults · NA · recruiting
Other Shouldice Hospital trials
Trials by the same sponsor.
- NCT06314802 — Learning Curve of the Shouldice Procedure · unknown
- NCT06037304 — Quality of Life After Shouldice Repair · unknown
- NCT06314815 — Ilioinguinal-iliohypogastric Nerve Block Prior to Shouldice Inguinal Hernia Repair · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05879770 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shouldice Hospital
- Last refreshed: 30 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05879770.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing