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RECRUITING
NCT05867225
NA

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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