NCT05867225 Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
| NCT ID | NCT05867225 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Large Hiatal Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2028-01-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2024-01-15 with a primary completion date of 2028-01-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Caroline Gronnier, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05867225 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large Hiatal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05867225 currently recruiting?
Yes, NCT05867225 is actively recruiting participants. Contact the research team at caroline.gronnier@chu-bordeaux.fr for enrollment information.
Where is the NCT05867225 trial being conducted?
This trial is being conducted at Bayonne, France, Besançon, France, Brest, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT05867225 clinical trial?
NCT05867225 is sponsored by University Hospital, Bordeaux. The principal investigator is Caroline Gronnier, MD, PhD at University Hospital, Bordeaux. The trial plans to enroll 256 participants.