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Clinical Trials in France / NCT05867225
Recruiting Not applicable

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

NCT05867225 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Bordeaux
Phase
Not applicable
Started
2024-01-15
Last updated
2024-01-18

Condition(s) studied

Large Hiatal Hernia

Investigational drug(s) / intervention(s)

Laparoscopic hiatal hernia repair

Laparoscopic hiatal hernia repair: laparoscopic hiatal hernia repair has replaced the traditional laparotomic or thoracotomic approach, and has resulted in a reduction of length of hospital stay and morbidity, and increased patients' acceptance

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (26)

FacilityCityRegionStatus
CH de la Côte Basque Bayonne France Not Yet Recruiting
Hôpital Jean Minjoz, CHRU de Besançon Besançon France Not Yet Recruiting
Hôpital Cavale blanche, CHRU de Brest Brest France Not Yet Recruiting
Hôpital Côte de nacre, CHU Caen Normandie Caen France Not Yet Recruiting
Hôpital Estang Clermont-Ferrand France Not Yet Recruiting
Hôpital Louis-Mourier, AP-HP Colombes France Not Yet Recruiting
Hôpital Nord, CHU de Grenoble La Tronche France Not Yet Recruiting
Hôpital Claude Huriez, CHRU de Lille Lille France Not Yet Recruiting
Polyclinique du bois, Hôpital privé Le Bois Lille France Not Yet Recruiting
Hôpital Dupuytren 1, CHU de Limoges Limoges France Not Yet Recruiting
Hôpital de la Croix-Rousse, HCL Lyon France Not Yet Recruiting
Hôpital Saint Eloi, CHU de Montpellier Montpellier France Not Yet Recruiting
Hôpital Hôtel Dieu, CHU de Nantes Nantes France Not Yet Recruiting
Hôpital Archet, CHU de Nice Nice France Not Yet Recruiting
Hôpital Saint-Louis, AP-HP Paris France Not Yet Recruiting
Hôpital Saint-Antoine, AP-HP Paris France Not Yet Recruiting
DMU SAPERE, CHU Pitié-Salpêtrière APHP Paris France Not Yet Recruiting
Institut Mutualiste Montsouris Paris France Not Yet Recruiting
Hôpital Bichat, AP-HP Paris France Not Yet Recruiting
Hôpital du Haut Lévêque Pessac France Recruiting
Hôpital Jean-Bernard, CHU de Poitiers Poitiers France Not Yet Recruiting
CH René-Dubos Pontoise France Recruiting
CHU de Rennes, Site PONTCHAILLOU Rennes France Not Yet Recruiting
Hôpital Charles Nicolle, CHU de Rouen Rouen France Not Yet Recruiting
Hôpital Felix-Guyon, CHU de la Réunion Saint-Paul France Not Yet Recruiting
Hôpital Rangueil, CHU de Toulouse Toulouse France Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05867225 on ClinicalTrials.gov ↗ ← All trials in France