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Comparing mesh repair to standard surgery for large hiatal hernias

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

Not applicable Interventional University Hospital, Bordeaux · NCT05867225

This study is testing if using a special mesh during surgery for large hiatal hernias helps prevent them from coming back compared to regular stitching, and it's for adults who have symptoms from these hernias.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment256 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Bordeaux Academic / other
Locations26 sites (Bayonne and 25 other locations)
Trial IDNCT05867225 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of using a biosynthetic absorbable mesh in laparoscopic repair of large hiatal hernias compared to standard suture repair without mesh. The study will assess the radiologic recurrence rate of hernias at two years post-surgery, as well as the improvement of specific symptoms in patients. Participants will be adults with symptomatic large hiatal hernias, defined as those larger than 5 cm, and will undergo a standardized surgical approach. The trial seeks to determine if the addition of mesh can reduce the rate of recurrence without increasing complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic large hiatal hernias.

Not a fit: Patients with asymptomatic hiatal hernias or those requiring reoperation for recurrent hernias may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of large hiatal hernias and improve patient outcomes.

How similar studies have performed: While there is limited comparative effectiveness data available, previous studies have suggested that mesh reinforcement may help prevent recurrence, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bayonne and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Large Hiatal HerniaRecurrenceSurgeryBiosynthetic absorbable mesh
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.