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MD","+335.61.32.21.88","carrere.n@chu-toulouse.fr",{"name":412,"role":29,"phone":25,"phoneExt":25,"email":25},{"type":417,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100505887","onlay-synthetic-bioabsorbable-mesh-herniorrhaphy-versus-herniorrhaphy-only-in-the-primary-treatment-of-large-hiatal-hernia-100505887",false,"NCT05867225","Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia","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","Inclusion Criteria:\n\n* 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\u002For CT-scan with contrast swallow and\u002For CT-scan with contrast injection with axial reconstruction.\n* Symptomatic hiatal hernia: heartburn and\u002For regurgitation and\u002For epigastric pain and\u002For dysphagia and\u002For anemia (if exclusion of other origin);\n* Patient aged ≥ 18 years;\n* Patient affiliated to a social security system or beneficiary of the same;\n* 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).\n\nExclusion Criteria:\n\n* Patient undergoing reoperation for recurrent LHH repair;\n* Emergency presentation needing an operation in a delay \\\u003C6 hours;\n* Asymptomatic hiatal hernia;\n* American anesthesiologist score \\>3;\n* Recurrent hiatal hernia and previous surgical interventions involving gastroesophageal junction;\n* 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;\n* Previous major upper gastrointestinal surgery;\n* Inability to perform primary closure of the crura;\n* Pregnant or breast-feeding woman;\n* Persons deprived of liberty or under guardianship or incapable of giving consent;\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator.","ALL","18 Years",{"count":429,"type":430},256,"ESTIMATED","INTERVENTIONAL",[433],"NA","The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice.\n\nIn 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.\n\nHypothesis: 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.\n\nThe 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.",[436],"Large Hiatal Hernia",[436,438,439,9],"Recurrence","Surgery","2024-01-17",{"date":442,"type":443},"2024-01-18","ACTUAL",{"date":445,"type":443},"2024-01-15",{"date":447,"type":430},"2028-01-18",{"name":5,"class":6},26]