Informations générales (source: ClinicalTrials.gov)
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 (HIATUS)
Interventional
N/A
University Hospital, Bordeaux (Voir sur ClinicalTrials)
janvier 2024
janvier 2028
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | TRELLES | 04/07/2024 11:04:59 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Simon Msika, MD, PhD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Louis Mourier | David Moszkowicz, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Emmanuel Attal, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH de la Côte Basque - 64100 - Bayonne - France | Laura Etchechoury, MD | Contact (sur clinicalTrials) | |||
| CHU de Rennes, Site PONTCHAILLOU - 35000 - Rennes - France | Damien Bergeat, MD | Contact (sur clinicalTrials) | |||
| DMU SAPERE, CHU Pitié-Salpêtrière APHP - 75013 - Paris - France | Laurent Genser, MD | Contact (sur clinicalTrials) | |||
| Hôpital Archet, CHU de Nice - 06000 - Nice - France | Antonio Ianelli, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Cavale blanche, CHRU de Brest - 29000 - Brest - France | Jérémie Théréaux, MD | Contact (sur clinicalTrials) | |||
| Hôpital Charles Nicolle, CHU de Rouen - 76000 - Rouen - France | Emmanuel Huet, MD | Contact (sur clinicalTrials) | |||
| Hôpital Claude Huriez, CHRU de Lille - 59000 - Lille - France | Guillaume Piessen, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Côte de nacre, CHU Caen Normandie - 14000 - Caen - France | Gil Lebreton, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix-Rousse, HCL - 69000 - Lyon - France | Salim Mezoughi, MD | Contact (sur clinicalTrials) | |||
| Hôpital du Haut Lévêque - 33600 - Pessac - France | Caroline Gronnier, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Dupuytren 1, CHU de Limoges - 87000 - Limoges - France | Muriel Mathonnet, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Estang - 63000 - Clermont-Ferrand - France | Olivier Antomarchi, MD | Contact (sur clinicalTrials) | |||
| Hôpital Felix-Guyon, CHU de la Réunion - 97415 - Saint Paul - France | Radwan Kassir, MD | Contact (sur clinicalTrials) | |||
| Hôpital Hôtel Dieu, CHU de Nantes - 44000 - Nantes - France | Claire Blanchard, MD | Contact (sur clinicalTrials) | |||
| Hôpital Jean Minjoz, CHRU de Besançon - 25000 - Besançon - France | Pierre Mathieu, MD | Contact (sur clinicalTrials) | |||
| Hôpital Jean-Bernard, CHU de Poitiers - 86000 - Poitiers - France | Jean-Pierre Faure, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Nord, CHU de Grenoble - 38700 - La Tronche - France | Fabian Reche, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Rangueil, CHU de Toulouse - 31000 - Toulouse - France | Nicolas Carrere, MD | Contact (sur clinicalTrials) | |||
| Hôpital Saint Eloi, CHU de Montpellier - 34000 - Montpellier - France | Jean-Michel Fabre, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis, AP-HP - 75010 - Paris - France | Hélène Corte, MD | Contact (sur clinicalTrials) | |||
| Institut Mutualiste Montsouris - 75014 - Paris - France | Stéphane Bonnet, MD, PhD | Contact (sur clinicalTrials) | |||
| Polyclinique du bois, Hôpital privé Le Bois - 5900 - Lille - France | Nicolas Briez, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient undergoing laparoscopic primary repair for symptomatic LHH. LHH is defined
as a hiatal hernia larger than 5 cm in axial length as diagnosed at barium series
and/or CT-scan with contrast swallow and/or CT-scan with contrast injection with
axial reconstruction.
- Symptomatic hiatal hernia: heartburn and/or regurgitation and/or epigastric pain
and/or dysphagia and/or anemia (if exclusion of other origin);
- Patient aged ≥ 18 years;
- Patient affiliated to a social security system or beneficiary of the same;
- Free written informed consent signed by the participant and the investigator (no
later than the inclusion day and before performing any examination required for the
study).
- Patient undergoing laparoscopic primary repair for symptomatic LHH. LHH is defined
as a hiatal hernia larger than 5 cm in axial length as diagnosed at barium series
and/or CT-scan with contrast swallow and/or CT-scan with contrast injection with
axial reconstruction.
- Symptomatic hiatal hernia: heartburn and/or regurgitation and/or epigastric pain
and/or dysphagia and/or anemia (if exclusion of other origin);
- Patient aged ≥ 18 years;
- Patient affiliated to a social security system or beneficiary of the same;
- Free written informed consent signed by the participant and the investigator (no
later than the inclusion day and before performing any examination required for the
study).
- Patient undergoing reoperation for recurrent LHH repair;
- Emergency presentation needing an operation in a delay <6 hours;
- Asymptomatic hiatal hernia;
- American anesthesiologist score >3;
- Recurrent hiatal hernia and previous surgical interventions involving
gastroesophageal junction;
- Brachyesophagus defined as the impossibility to achieve an intraabdominal length of
the esophagus of at least 3cm after reduction of hernia contents and complete
dissection and resection of the hernia sac;
- Previous major upper gastrointestinal surgery;
- Inability to perform primary closure of the crura;
- Pregnant or breast-feeding woman;
- Persons deprived of liberty or under guardianship or incapable of giving consent;
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol or follow-up schedule, as assessed by
investigator.