RecruitingNAINTERVENTIONAL

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

Many people develop a large hiatal hernia, where part of the stomach pushes up into the chest. This often causes problems like heartburn and discomfort. While surgery can fix this, the hernia sometimes comes back. This study aims to find out if using a special dissolvable mesh during surgery helps prevent the hernia from returning. Researchers will compare two groups: one has the standard hernia repair, and the other has the standard repair with the added mesh. The main goal is to see if adding the mesh reduces the chances of the hernia recurring within two years, without increasing complications. This could lead to more effective treatments for large hiatal hernias.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

256

Start

15 Jan 2024

Estimated completion

18 Jan 2028

Large Hiatal Hernia

What is this study about?

A large hiatal hernia is a condition where a part of your stomach squeezes up through an opening in your diaphragm – the muscle that separates your chest from your tummy. This can cause uncomfortable symptoms like heartburn, food coming back up, and stomach pain. It's becoming more common, especially as people get older. Sometimes, even after surgery to fix it, the hernia can return, which is frustrating for patients and doctors.

Doctors have been looking for ways to make hernia repairs last longer. One idea is to use a special, dissolvable mesh to strengthen the repair. This mesh is designed to be absorbed by your body over time, leaving behind stronger tissue. This particular study wants to see if adding this special mesh during a keyhole (laparoscopic) surgery for large hiatal hernias is more effective than the usual surgery without the mesh.

The main aim is to compare how often the hernia comes back in two years in patients who have the mesh versus those who don't. The researchers also want to look at other important things, like how much patients' symptoms improve, their quality of life, and if the mesh causes any more problems or complications. The hope is that the mesh will reduce the chance of the hernia returning without making the surgery riskier.

Key takeaways

Aims to find out if dissolvable mesh helps prevent large hiatal hernias from returning.
Compares standard hernia repair with and without mesh.
Follows patients for two years after surgery.
Measures hernia recurrence, symptom relief, and quality of life.
Could improve future treatment for large hiatal hernias.

Who may be eligible?

To be considered for this study, you would generally need to be an adult (18 years or older) who is experiencing symptoms from a large hiatal hernia. A large hiatal hernia is typically defined as being bigger than 5 cm when measured by scans like X-rays or CT scans. Your symptoms might include heartburn, regurgitation (food coming back up), stomach pain, or anaemia (low iron).

You wouldn't be able to join if you've already had surgery for a recurrent hiatal hernia or if your hernia needs emergency surgery right away. People who don't have symptoms from their hernia, or those with other significant existing health problems, would also not be suitable. Women who are pregnant or breastfeeding, or people who have had certain major stomach surgeries before would also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have symptoms from a large hiatal hernia?
Has your large hiatal hernia been confirmed by scans?
Have you NOT had surgery for a recurrent hiatal hernia before?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve having surgery for your large hiatal hernia, which would either include the special mesh or not, based on a random assignment. You'd have regular check-ups and scans to monitor your health and the hernia's status for two years after the surgery. The doctors would also ask you about your symptoms and quality of life at these visits. The exact number of visits and tests would be explained in detail by the study team, but they would be spread out over the two-year period.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. The potential benefit of this study is that if you receive the mesh, it might lower the chance of your hernia coming back, potentially improving your long-term comfort and quality of life. However, as with any surgery, there are risks, and the researchers will be carefully monitoring for any complications, including those that might arise from the mesh. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (26)

CH de la Côte Basque
Verified postcode
Bayonne, France· Not yet recruiting
Hôpital Jean Minjoz, CHRU de Besançon
Verified postcode
Besançon, France· Not yet recruiting
Hôpital Cavale blanche, CHRU de Brest
Verified postcode
Brest, France· Not yet recruiting
Hôpital Côte de nacre, CHU Caen Normandie
Verified postcode
Caen, France· Not yet recruiting
Hôpital Estang
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
Hôpital Louis-Mourier, AP-HP
Verified postcode
Colombes, France· Not yet recruiting
Hôpital Nord, CHU de Grenoble
Verified postcode
La Tronche, France· Not yet recruiting
Hôpital Claude Huriez, CHRU de Lille
Verified postcode
Lille, France· Not yet recruiting
Polyclinique du bois, Hôpital privé Le Bois
Verified postcode
Lille, France· Not yet recruiting
Hôpital Dupuytren 1, CHU de Limoges
Verified postcode
Limoges, France· Not yet recruiting
Hôpital de la Croix-Rousse, HCL
Verified postcode
Lyon, France· Not yet recruiting
Hôpital Saint Eloi, CHU de Montpellier
Verified postcode
Montpellier, France· Not yet recruiting

Common questions

What is a large hiatal hernia?

It's when part of your stomach pushes up through an opening in your diaphragm, which separates your chest and abdomen, causing symptoms like heartburn.

What is 'mesh' and how is it used?

Mesh is like a strong, dissolvable patch used to reinforce the repair during surgery, making it stronger. It's meant to be absorbed by your body over time.

Will I know if I get the mesh or not?

Like many studies, you might not know whether you received the mesh or had the standard repair without it, to ensure the results are fair and unbiased.

How long will I be involved in the study?

You would be followed up for two years after your surgery to see how well the repair holds up and how you are feeling.

What are the potential benefits of this research?

This research could help improve how large hiatal hernias are treated, potentially leading to fewer operations for patients in the future.

How to find out more

Caroline Gronnier, MD, PhD

caroline.gronnier@chu-bordeaux.fr + 33 5 57 65 60 05 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.