Brief 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.

Conditions

• Large Hiatal Hernia

Intervention / Treatment

• Procedure: Laparoscopic hiatal hernia repair

Primary Outcome Measures

• Number of Large Hiatal Hernia recurrence (Month 24)
  Radiologic recurrence will be identified at 24 months by an experienced radiologist blinded to the result of randomization and defined as the presence of any abdominal content located above the level of the diaphragm on CT-scan.

Countries

France

Locations and Investigators

• CH de la Côte Basque, Bayonne, France (Not yet recruiting)
  • Laura Etchechoury, MD
  • Laura Etchechoury, MD (Principal Investigator)
• Hôpital Jean Minjoz, CHRU de Besançon, Besançon, France (Not yet recruiting)
  • Pierre Mathieu, MD
  • Pierre Mathieu, MD (Principal Investigator)
• Hôpital Cavale blanche, CHRU de Brest, Brest, France (Not yet recruiting)
  • Jérémie Théréaux, MD
  • Jérémie Théréaux, MD (Principal Investigator)
• Hôpital Côte de nacre, CHU Caen Normandie, Caen, France (Not yet recruiting)
  • Gil Lebreton, MD
  • Gil Lebreton, MD (Principal Investigator)
• Hôpital Estang, Clermont-Ferrand, France (Not yet recruiting)
  • Olivier Antomarchi, MD
  • Olivier Antomarchi, MD (Principal Investigator)
• Hôpital Louis-Mourier, AP-HP, Colombes, France (Not yet recruiting)
  • David Moszkowicz, MD
  • David Moszkowicz, MD (Principal Investigator)
• Hôpital Nord, CHU de Grenoble, La Tronche, France (Not yet recruiting)
  • Fabian Reche, MD, PhD
  • Fabian Reche, MD, PhD (Principal Investigator)
• Hôpital Claude Huriez, CHRU de Lille, Lille, France (Not yet recruiting)
  • Guillaume Piessen, MD, PhD
  • Guillaume Piessen, MD, PhD (Principal Investigator)
• Polyclinique du bois, Hôpital privé Le Bois, Lille, France (Not yet recruiting)
  • Nicolas Briez, MD
  • Nicolas Briez, MD (Principal Investigator)
• Hôpital Dupuytren 1, CHU de Limoges, Limoges, France (Not yet recruiting)
  • Muriel Mathonnet, MD, PhD
  • Muriel Mathonnet, MD, PhD (Principal Investigator)
• Hôpital de la Croix-Rousse, HCL, Lyon, France (Not yet recruiting)
  • Salim Mezoughi, MD
  • Salim Mezoughi, MD (Principal Investigator)
• Hôpital Saint Eloi, CHU de Montpellier, Montpellier, France (Not yet recruiting)
  • Jean-Michel Fabre, MD, PhD
  • Jean-Michel Fabre, MD, PhD (Principal Investigator)
• Hôpital Hôtel Dieu, CHU de Nantes, Nantes, France (Not yet recruiting)
  • Claire Blanchard, MD
  • Claire Blanchard, MD (Principal Investigator)
• Hôpital Archet, CHU de Nice, Nice, France (Not yet recruiting)
  • Antonio Ianelli, MD, PhD
  • Antonio Ianelli, MD, PhD (Principal Investigator)
• Hôpital Saint-Louis, AP-HP, Paris, France (Not yet recruiting)
  • Hélène Corte, MD
  • Hélène Corte, MD (Principal Investigator)
• Hôpital Saint-Antoine, AP-HP, Paris, France (Not yet recruiting)
  • Emmanuel Attal, MD
  • Emmanuel Attal, MD (Principal Investigator)
• DMU SAPERE, CHU Pitié-Salpêtrière APHP, Paris, France (Not yet recruiting)
  • Laurent Genser, MD
  • Laurent Genser, MD (Principal Investigator)
• Institut Mutualiste Montsouris, Paris, France (Not yet recruiting)
  • Stéphane Bonnet, MD, PhD
  • Stéphane Bonnet, MD, PhD (Principal Investigator)
• Hôpital Bichat, AP-HP, Paris, France (Not yet recruiting)
  • Simon Msika, MD, PhD
  • Simon Msika, MD, PhD (Principal Investigator)
• Hôpital du Haut Lévêque, Pessac, France (Recruiting)
  • Caroline Gronnier, MD, PhD
  • Caroline Gronnier, MD, PhD (Principal Investigator)
• Hôpital Jean-Bernard, CHU de Poitiers, Poitiers, France (Not yet recruiting)
  • Jean-Pierre Faure, MD, PhD
  • Jean-Pierre Faure, MD, PhD (Principal Investigator)
• CH René-Dubos, Pontoise, France (Recruiting)
  • Nelson Trelles, MD
  • Nelson Trelles, MD (Principal Investigator)
• CHU de Rennes, Site PONTCHAILLOU, Rennes, France (Not yet recruiting)
  • Damien Bergeat, MD
  • Damien Bergeat, MD (Principal Investigator)
• Hôpital Charles Nicolle, CHU de Rouen, Rouen, France (Not yet recruiting)
  • Emmanuel Huet, MD
  • Emmanuel Huet, MD (Principal Investigator)
• Hôpital Felix-Guyon, CHU de la Réunion, Saint Paul, France (Not yet recruiting)
  • Radwan Kassir, MD
  • Radwan Kassir, MD (Principal Investigator)
• Hôpital Rangueil, CHU de Toulouse, Toulouse, France (Not yet recruiting)
  • Nicolas Carrere, MD
  • Nicolas Carrere, MD (Principal Investigator)

Study Officials

• Caroline Gronnier, MD, PhD (Principal Investigator) — University Hospital, Bordeaux