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Study identifier: NCT05867225 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia

Condition: Large Hiatal Hernia  ·  Sponsor: University Hospital, Bordeaux

PhaseNA
Planned participants256
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Caroline Gronnier, MD, PhD  ·  + 33 5 57 65 60 05  ·  caroline.gronnier@chu-bordeaux.fr

Valérie Aurillac-Lavignolle  ·  +33 5 57 82 24 77  ·  valerie.aurillac@chu-bordeaux.fr

Always discuss trial participation with your own doctor first.

Locations (26)

CH de la Côte BasqueBayonne, FranceNot Yet Recruiting
Hôpital Jean Minjoz, CHRU de BesançonBesançon, FranceNot Yet Recruiting
Hôpital Cavale blanche, CHRU de BrestBrest, FranceNot Yet Recruiting
Hôpital Côte de nacre, CHU Caen NormandieCaen, FranceNot Yet Recruiting
Hôpital EstangClermont-Ferrand, FranceNot Yet Recruiting
Hôpital Louis-Mourier, AP-HPColombes, FranceNot Yet Recruiting
Hôpital Nord, CHU de GrenobleLa Tronche, FranceNot Yet Recruiting
Hôpital Claude Huriez, CHRU de LilleLille, FranceNot Yet Recruiting
Polyclinique du bois, Hôpital privé Le BoisLille, FranceNot Yet Recruiting
Hôpital Dupuytren 1, CHU de LimogesLimoges, FranceNot Yet Recruiting
Hôpital de la Croix-Rousse, HCLLyon, FranceNot Yet Recruiting
Hôpital Saint Eloi, CHU de MontpellierMontpellier, FranceNot Yet Recruiting

+ 14 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05867225