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

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.

NCT Number	NCT05867225
Lead Sponsor	University Hospital, Bordeaux
Conditions	Large Hiatal Hernia
Enrollment	256 participants
Start Date	2024-01-15
Primary Completion	2028-01-18 (estimated)
Study Completion	2028-01-18 (estimated)
Updated on ClinicalTrials.gov	2024-01-18