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Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
Sponsor: University Hospital, Bordeaux
Summary
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.
Official title: Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia: a Multicenter, Randomized, Parallel-group, Evaluator Blinded, Phase III Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
256
Start Date
2024-01-15
Completion Date
2028-01-18
Last Updated
2024-01-18
Healthy Volunteers
No
Conditions
Interventions
Laparoscopic hiatal hernia repair
laparoscopic hiatal hernia repair has replaced the traditional laparotomic or thoracotomic approach, and has resulted in a reduction of length of hospital stay and morbidity, and increased patients' acceptance
Locations (26)
CH de la Côte Basque
Bayonne, France
Hôpital Jean Minjoz, CHRU de Besançon
Besançon, France
Hôpital Cavale blanche, CHRU de Brest
Brest, France
Hôpital Côte de nacre, CHU Caen Normandie
Caen, France
Hôpital Estang
Clermont-Ferrand, France
Hôpital Louis-Mourier, AP-HP
Colombes, France
Hôpital Nord, CHU de Grenoble
La Tronche, France
Hôpital Claude Huriez, CHRU de Lille
Lille, France
Polyclinique du bois, Hôpital privé Le Bois
Lille, France
Hôpital Dupuytren 1, CHU de Limoges
Limoges, France
Hôpital de la Croix-Rousse, HCL
Lyon, France
Hôpital Saint Eloi, CHU de Montpellier
Montpellier, France
Hôpital Hôtel Dieu, CHU de Nantes
Nantes, France
Hôpital Archet, CHU de Nice
Nice, France
Hôpital Saint-Louis, AP-HP
Paris, France
Hôpital Saint-Antoine, AP-HP
Paris, France
DMU SAPERE, CHU Pitié-Salpêtrière APHP
Paris, France
Institut Mutualiste Montsouris
Paris, France
Hôpital Bichat, AP-HP
Paris, France
Hôpital du Haut Lévêque
Pessac, France
Hôpital Jean-Bernard, CHU de Poitiers
Poitiers, France
CH René-Dubos
Pontoise, France
CHU de Rennes, Site PONTCHAILLOU
Rennes, France
Hôpital Charles Nicolle, CHU de Rouen
Rouen, France
Hôpital Felix-Guyon, CHU de la Réunion
Saint-Paul, France
Hôpital Rangueil, CHU de Toulouse
Toulouse, France