Comparing mesh repair to standard surgery for large hiatal hernias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital du Haut Lévêque
  Pessac, France Recruiting
• CH René-Dubos
  Pontoise, France Recruiting
• 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

Study contacts

• Principal investigator: Caroline Gronnier, MD, PhD — University Hospital, Bordeaux
• Study coordinator: Caroline Gronnier, MD, PhD
• Email: caroline.gronnier@chu-bordeaux.fr
• Phone: + 33 5 57 65 60 05

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two surgical methods for hiatal hernia repair

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• Using a special mesh to improve hiatal hernia surgery outcomes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.