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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Bordeaux
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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). Exclusion Criteria: * 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.
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What it tests

  • Laparoscopic hiatal hernia repair
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Where

26 sites
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

…and 18 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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