RecruitingNAINTERVENTIONAL

Health-economic Assessment of Robot-assisted Bariatric Surgery

This important study looks at how effective and cost-effective two different types of weight-loss surgery are for people living with obesity. Researchers are comparing robot-assisted surgery with the more traditional keyhole (laparoscopic) surgery. The main goal is to find out if the extra cost of using a robot is worth it, especially if it leads to fewer complications and a better quality of life for patients one year after their operation. They will track patients' progress and collect information about their health, daily activities, and how satisfied they are with their health and well-being. This will help doctors and healthcare planners decide the best way to offer this life-changing surgery in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

482

Start

25 Jul 2025

Estimated completion

01 Jul 2028

Obesity

What is this study about?

This study is about a common and effective treatment for serious obesity: weight-loss surgery. In parts of Europe, a lot of people are affected by obesity, and surgery can make a big difference to their health and quality of life. There are a couple of ways these operations can be done. One is using traditional keyhole surgery, which is very common. The other, newer method involves doctors using a robot to help them perform the operation. While robot-assisted surgery has shown benefits for some other operations, it's not yet fully clear if it's better for weight-loss surgery, especially given that it can be more expensive.

This research aims to find out if robot-assisted weight-loss surgery is truly better than standard keyhole surgery. They'll be looking at things like how many people have complications, how quickly people recover, and how patients feel about their quality of life a year after surgery. They also want to understand the costs involved for the healthcare system. The results of this study will be very important for deciding how weight-loss surgery is offered in the future. It could either show that robot-assisted surgery is a great option, or it might confirm that standard keyhole surgery remains the best choice for most people.

Ultimately, this study's findings will directly influence patient care, helping doctors and policymakers make informed decisions. It will guide choices about which surgical approach is most effective, safe, and efficient, ensuring that patients receive the best possible care for obesity. It's all about making sure that the valuable resources of the healthcare system are used in the best way to achieve the best outcomes for patients.

Key takeaways

This study compares robot-assisted and standard keyhole weight-loss surgery.
It aims to see which method is safer and better for patients' quality of life.
Researchers will also consider the cost implications for the healthcare system.
Participation involves being randomly assigned to one of the two surgery types.
Your health and well-being will be tracked for one year after the operation.
The findings will help guide future decisions about weight-loss surgery care.

Who may be eligible?

To be considered for this study, you'd generally need to be between 18 and 70 years old. You might be eligible if you're having weight-loss surgery for the first time and meet certain body mass index (BMI) conditions. For example, if your BMI is 40 or more, or 35 or more with other health problems that might improve after surgery, like high blood pressure or type 2 diabetes. If you have type 2 diabetes and your BMI is between 30 and 35, you might also be considered.

The study also includes people who need another weight-loss operation because of problems or side effects from a previous surgery. Importantly, you would have already had discussions with a team of doctors, specialists, and nurses, and they would have agreed that bariatric surgery is a good option for you.

However, some things would mean you couldn't join. This includes having a severe illness that isn't related to your weight, being pregnant or planning to get pregnant during the study, or if you're unable to understand or give consent. You also need to be part of a French or European health insurance system and be able to understand French.

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 between 18 and 70 years old?
Are you scheduled for weight-loss surgery for the first time, or for a revision?
Has a team of specialists agreed that weight-loss surgery is right for you?
Are you able to understand and give your consent to take part?
Are you not pregnant or planning to be during the next year?
Do you understand French?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be randomly assigned to receive either robot-assisted weight-loss surgery or standard keyhole surgery. This is a bit like flipping a coin, so neither you nor your doctors can choose which type you get. During the study, you'll have your surgery and then several checks afterwards. You'll be asked to complete questionnaires about your health, how you feel, and how your weight affects your daily life. Your information will also be linked to your health records to gather details about any hospital visits or medical care you receive. The main part of tracking your health and quality of life will continue for one year after your surgery. There are no specific medications provided as part of the study, as it's focused on the surgical technique.

Potential risks and benefits

Participating in any medical study has potential benefits and risks. A potential benefit of taking part is that you might receive robot-assisted surgery, which *could* lead to fewer complications, although this is what the study aims to find out. Both surgical methods carry risks, which your surgical team will discuss with you, including general risks of surgery like infection or bleeding, and specific risks related to weight-loss surgery. You will be closely monitored throughout the study, which means regular check-ups on your health. It's crucial to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (17)

Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX
Verified postcode
Bordeaux, France· Recruiting
Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON
Verified postcode
Dijon, France· Recruiting
Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09
Verified postcode
Grenoble, France· Recruiting
Service de Chirurgie Générale et Digestive Grand Hopital de l'Est Francilien Site de Marne La Vallée 2-4 Cours de la Gondoire 77600 JOSSIGNY
Verified postcode
Jossigny, France· Recruiting
Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE
Verified postcode
Lille, France· Recruiting
Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE
Verified postcode
Lyon, France· Recruiting
Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 MARSEILLE
Verified postcode
Marseille, France· Not yet recruiting
Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES
Verified postcode
Nantes, France· Recruiting
Département de Chirurgie digestive Hôpital de la Source CHU d'ORLEANS 14 Avenue de l'hôpital 45100 ORLEANS LA SOURCE
Verified postcode
Orléans, France· Recruiting
Service de Chirurgie Digestive Hépato-bilio-pancréatique et Transplantation Hépatique Chirurgie Bariatrique, coelioscopique et robotique AP-HP - Hôpital Universitaire La Pitié Salpêtrière 47-83 boulevard de l'hôpital 75013 PARIS
Verified postcode
Paris, France· Recruiting
Département de chirurgie digestive, oncologique et bariatrique AP-HP - Hôpital Européen Georges Pompidou 20 rue Leblanc 75015 PARIS
Verified postcode
Paris, France· Recruiting
Département de chirurgie digestive, œsogastrique et bariatrique AP-HP - Hôpital Bichat - Claude-Bernard 46 Rue Henri Huchard 75018 PARIS
Verified postcode
Paris, France· Recruiting

Common questions

What is obesity?

Obesity is a serious health condition where a person has accumulated too much body fat, which can lead to other health problems like diabetes or heart disease. It's measured using something called Body Mass Index (BMI).

What is 'robot-assisted surgery'?

This is a type of keyhole surgery where the surgeon uses a special computer console to control robotic arms, which hold tiny surgical tools and a camera. It allows for very precise movements.

What is 'keyhole' or 'laparoscopic' surgery?

This is a common surgical method where doctors make several small cuts instead of one large one. They use a tiny camera and long, thin instruments to perform the operation inside your body.

Will I get to choose which surgery I have?

No, if you join this study, you'll be randomly assigned to either the robot-assisted group or the standard keyhole surgery group. This is to make sure the comparison is fair.

What does 'quality of life' mean in this study?

It means how well you feel and function in your daily life, and how your health affects your happiness and abilities. The study will ask questions about this through special questionnaires.

How to find out more

Maud ROBERT, MD, PHD

maud.robert@chu-lyon.fr +33 4 72 11 62 63 Official trial record

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