Last reviewed · How we verify
NCT05867225: HIATUS
Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
NA trial testing Laparoscopic hiatal hernia repair in Large Hiatal Hernia in 256 participants. Currently enrolling.
18 January 2028
Quick facts
| Lead sponsor | University Hospital, Bordeaux |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 256 |
| Start date | 15 January 2024 |
| Primary completion | 18 January 2028 |
| Estimated completion | 18 January 2028 |
| Sites | 26 locations across France |
Drugs / interventions tested
- Laparoscopic hiatal hernia repair
Conditions studied
- Large Hiatal Hernia — all drugs for Large Hiatal Hernia →
Sponsor
University Hospital, Bordeaux
Who can join
18 and older, any sex, with Large Hiatal Hernia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05867225
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other University Hospital, Bordeaux trials
Trials by the same sponsor.
- NCT07506928 — NEURO - Prognostication Using Late Somatosensory Evoked - Potentials · NA · not yet recruiting
- NCT07524036 — Impact of a Nursing Educational Consultation on the Patient's Adherence to Their Post-stroke Care Plan. · NA · not yet recruiting
- NCT07527494 — Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction · NA · not yet recruiting
- NCT07527442 — Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Va · Phase 2 · not yet recruiting
- NCT07478523 — FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers · Phase 2 · not yet recruiting
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 NCT05867225 (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 University Hospital, Bordeaux
- Last refreshed: 18 January 2024
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/NCT05867225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing