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
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
France
CH de la Côte Basque
NOT_YET_RECRUITING
Bayonne
Hôpital Jean Minjoz, CHRU de Besançon
NOT_YET_RECRUITING
Besançon
Hôpital Cavale blanche, CHRU de Brest
NOT_YET_RECRUITING
Brest
Hôpital Côte de nacre, CHU Caen Normandie
NOT_YET_RECRUITING
Caen
Hôpital Estang
NOT_YET_RECRUITING
Clermont-ferrand
Hôpital Louis-Mourier, AP-HP
NOT_YET_RECRUITING
Colombes
Hôpital Nord, CHU de Grenoble
NOT_YET_RECRUITING
La Tronche
Hôpital Claude Huriez, CHRU de Lille
NOT_YET_RECRUITING
Lille
Polyclinique du bois, Hôpital privé Le Bois
NOT_YET_RECRUITING
Lille
Hôpital Dupuytren 1, CHU de Limoges
NOT_YET_RECRUITING
Limoges
Hôpital de la Croix-Rousse, HCL
NOT_YET_RECRUITING
Lyon
Hôpital Saint Eloi, CHU de Montpellier
NOT_YET_RECRUITING
Montpellier
Hôpital Hôtel Dieu, CHU de Nantes
NOT_YET_RECRUITING
Nantes
Hôpital Archet, CHU de Nice
NOT_YET_RECRUITING
Nice
DMU SAPERE, CHU Pitié-Salpêtrière APHP
NOT_YET_RECRUITING
Paris
Hôpital Bichat, AP-HP
NOT_YET_RECRUITING
Paris
Hôpital Saint-Antoine, AP-HP
NOT_YET_RECRUITING
Paris
Hôpital Saint-Louis, AP-HP
NOT_YET_RECRUITING
Paris
Institut Mutualiste Montsouris
NOT_YET_RECRUITING
Paris
Hôpital du Haut Lévêque
RECRUITING
Pessac
Hôpital Jean-Bernard, CHU de Poitiers
NOT_YET_RECRUITING
Poitiers
CH René-Dubos
RECRUITING
Pontoise
CHU de Rennes, Site PONTCHAILLOU
NOT_YET_RECRUITING
Rennes
Hôpital Charles Nicolle, CHU de Rouen
NOT_YET_RECRUITING
Rouen
Hôpital Felix-Guyon, CHU de la Réunion
NOT_YET_RECRUITING
Saint-paul
Hôpital Rangueil, CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Caroline Gronnier, MD, PhD
caroline.gronnier@chu-bordeaux.fr
+ 33 5 57 65 60 05
Backup
Valérie Aurillac-Lavignolle
valerie.aurillac@chu-bordeaux.fr
+33 5 57 82 24 77
Time Frame
Start Date:2024-01-15
Estimated Completion Date:2028-01-18
Participants
Target number of participants:256
Treatments
Experimental: Biosynthetic absorbable mesh
Patients who have undergone hiatal surgery with use of a biosynthetic absorbable mesh
Sham_comparator: No biosynthetic absorbable mesh
Patients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh