RecruitingOBSERVATIONAL

Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study

This study is looking into a new way to perform weight-loss surgery for obesity, specifically comparing it to the standard stomach-reduction procedure (called sleeve gastrectomy). The standard surgery is very effective for weight loss, but it can lead to problems like severe acid reflux (heartburn) in some people. This new approach, called Nissen Sleeve Gastrectomy, adds an extra step designed to help prevent or reduce this reflux. Researchers want to see if this modified surgery reduces complications, particularly acid reflux, compared to the traditional technique. The aim is to improve patients' health and quality of life after surgery by finding a way to fewer troublesome side effects.

At a glance

Status

Recruiting

Sponsor

Nantes University Hospital

Enrolment target

100

Start

01 Mar 2024

Estimated completion

01 Mar 2027

Obesity

What is this study about?

Obesity is a significant health concern for many people, and sometimes, surgical treatment becomes the most effective option. One common weight-loss operation is called a sleeve gastrectomy. This procedure involves removing a large part of the stomach, making it much smaller and helping people eat less and lose a lot of weight. It has been very successful for many, often improving other health conditions linked to obesity.

However, like all surgeries, sleeve gastrectomy can have side effects. A common and sometimes serious problem is acid reflux, or heartburn, where stomach acid travels back up into the food pipe. This can be uncomfortable and, in some cases, lead to more serious issues over time. Medications can help, but they might not be a long-term solution for everyone, and sometimes further surgery is needed to fix the reflux.

This study explores a new twist on the sleeve gastrectomy, called the Nissen Sleeve Gastrectomy. This modified surgery includes an extra step, similar to operations used to treat acid reflux independently. The idea is to create a barrier that helps stop stomach acid from coming back up the food pipe. Researchers want to see if adding this step makes the surgery safer and reduces the risk of acid reflux problems compared to the standard sleeve gastrectomy, leading to better results and a higher quality of life for patients.

Key takeaways

This study compares two stomach-reduction surgeries for obesity.
It aims to find out if a newer technique (Nissen Sleeve) reduces acid reflux.
Acid reflux is a common and sometimes serious side effect of standard sleeve gastrectomy.
The study is for adults undergoing weight-loss surgery in France who meet specific health criteria.

Who may be eligible?

To join this study, you would generally need to be an adult in France who is undergoing weight-loss surgery. You must be planning to have a sleeve gastrectomy after being assessed by a team of healthcare professionals. This typically means you have severe obesity (a BMI of 40 or more) or a BMI of 35 or more along with other health problems that could improve with weight loss, such as high blood pressure or type 2 diabetes.

However, certain things would mean you couldn't take part. For example, if you've already had weight-loss surgery before, or if you have specific serious conditions of the food pipe or stomach like severe acid reflux damage (Barrett's esophagus or severe oesophagitis). Also, if you are pregnant, unable to understand the study, or planning to live outside the area, you wouldn't be able to participate. The study also has some specific BMI limits for men and women.

Basically, the study is for people who meet the standard criteria for having sleeve gastrectomy in France, but do not have certain medical conditions that might make the new procedure unsuitable or unsafe. It’s important that you can attend all appointments and follow the study instructions.

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 an adult aged 18 or over?
Are you planning to have sleeve gastrectomy for obesity?
Do you have a BMI of 40 or more, or 35 or more with other health problems?
Have you not had previous weight-loss surgery?
Do you NOT have severe problems with your food pipe or stomach lining (like severe acid reflux damage)?
Are you able to attend all planned hospital visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

The detailed participation information isn't fully available in the provided text. However, typically, if you join a study like this, you would receive either the standard sleeve gastrectomy or the Nissen Sleeve Gastrectomy. Researchers would then compare your recovery and long-term health outcomes, especially looking at any complications like acid reflux. This would involve a series of follow-up appointments over time to monitor your health, perform tests, and ask about your comfort and quality of life. The total duration of your participation would depend on how long the researchers plan to track your health after surgery.

Potential risks and benefits

The potential benefit of participating could be helping researchers find a surgical technique that leads to fewer problems, especially less acid reflux, for people undergoing weight-loss surgery. This could improve your quality of life in the long run. However, all surgeries carry risks, including infection, bleeding, and serious reactions to anaesthesia. This study involves a stomach operation, which has its own specific risks such as leaks or blockages. There's also the unknown aspect of the new Nissen Sleeve technique; while designed to improve outcomes, it could have unforeseen risks. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU Nantes
Verified postcode
Nantes, France· Recruiting

Common questions

What is 'sleeve gastrectomy'?

It's a type of weight-loss surgery where a large part of your stomach is removed, leaving a smaller, banana-shaped stomach, which helps you eat less and feel full sooner.

What is acid reflux and why is it a problem after surgery?

Acid reflux, or heartburn, is when stomach acid comes back up into your food pipe. It can be uncomfortable and, in some cases, lead to more serious issues like damage to your food pipe over time, which sometimes happens after sleeve gastrectomy.

What is the 'Nissen Sleeve Gastrectomy' being studied?

This is a modified version of the sleeve gastrectomy. It includes an extra step that helps to reinforce the valve between your food pipe and stomach, aiming to reduce acid reflux.

Will I know which surgery I'm getting?

The information provided doesn't specify if participants will know which procedure they receive. In some studies, this is decided randomly to ensure fair comparison.

Is this study open to people outside of France?

Based on the information provided, this is a French study, and eligibility specifies being covered by public health insurance in France and potentially living in the region to attend visits.

How to find out more

Claire Louis, M.D

claire.blanchard@chu-nantes.fr 0240083022 Official trial record

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