Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
Recruiting now · Not applicable
Conditions studied: Large Hiatal Hernia
In brief
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.
Key facts
- Study ID
- NCT05867225
- Run by
- University Hospital, Bordeaux
- People needed
- 256
- Starts
- 2024-01-15
- Expected to finish
- 2028-01-18
- Last updated by the study team
- 2024-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Hôpital du Haut Lévêque — Pessac, France (enrolling)
- CH René-Dubos — Pontoise, France (enrolling)
- 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 Jean-Bernard, CHU de Poitiers — Poitiers, 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
- CH de la Côte Basque — Bayonne, France
- Hôpital Rangueil, CHU de Toulouse — Toulouse, France
Full record on ClinicalTrials.gov
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