RecruitingNAINTERVENTIONAL

ENDOmetriosis Robotic Assisted Surgery

This study, called ENDO-RAS, is comparing two ways of doing a hysterectomy (womb removal) for women with certain types of endometriosis and adenomyosis. Researchers want to see if using a robot to assist with keyhole surgery leads to fewer problems during or after the operation compared to standard keyhole surgery. This is for women whose endometriosis doesn't affect their digestive system. Doctors hope to find the safest and most effective surgical method for these conditions. If you meet the criteria, you would be randomly assigned to one of the two surgery groups. The study is running in multiple centres and is designed to fairly compare the two techniques.

At a glance

Status

Recruiting

Phase

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

224

Start

16 Apr 2025

Estimated completion

01 Jun 2027

Endometriosis

What is this study about?

This research study, known as ENDO-RAS, is looking into the best way to perform a hysterectomy (removal of the womb) for women who have specific types of endometriosis and adenomyosis. Endometriosis is a condition where tissue similar to the lining of the womb grows elsewhere in the body, and adenomyosis is when this tissue grows into the muscular wall of the womb. Both can cause pain and other symptoms.

The study aims to compare two different surgical methods: standard keyhole surgery (laparoscopy) and robot-assisted keyhole surgery. The main goal is to find out if using a robot to help with the surgery can reduce the number of complications, both during and after the operation. This is important because reducing complications can lead to a quicker recovery and better overall health outcomes for patients.

To ensure fair comparison, patients who join the study will be randomly assigned to receive one of these two types of surgery. This means that neither you nor your doctor can choose which surgery you have. Doctors will carefully check if your endometriosis and adenomyosis meet specific criteria, especially making sure that your digestive system is not affected. By studying these two techniques, researchers hope to improve surgical care for women living with these conditions.

Key takeaways

Compares robot-assisted keyhole surgery vs. standard keyhole surgery for hysterectomy.
Aims to find out which method leads to fewer complications during and after surgery.
Only for women with specific types of endometriosis and adenomyosis, not affecting the digestive system.
Patients are randomly assigned to one of the two surgery groups.
Requires you to have tried and failed at least two other medical treatments.
Participation involves close monitoring and is a multi-centre study.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have a diagnosis of both adenomyosis and deep infiltrating endometriosis, as confirmed by a special scan like an MRI. It's crucial that your endometriosis does not involve your digestive system.

Another important point is that you should have tried and failed at least two types of medical treatments for your condition. You must also be considered suitable for a total hysterectomy, which means your womb and all patches of endometriosis would be removed during the surgery.

There are also some reasons why you wouldn't be able to join. These include if your endometriosis affects your digestive system, if you only have adenomyosis without deep infiltrating endometriosis, or if there's any medical reason why surgery wouldn't be safe for you. The study is only for women, and you must also be able to provide written agreement to participate.

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 old or older?
Do you have a confirmed diagnosis of both adenomyosis and deep infiltrating endometriosis?
Has your doctor confirmed that your endometriosis does not involve your digestive system?
Have you tried at least two other medical treatments for your condition that haven't worked?
Are you considered suitable for a total hysterectomy?
Are you able to provide written consent to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is to carefully read and sign a consent form, making sure you understand everything. After this, you will be randomly assigned to one of two groups: one where you will have your hysterectomy with robot assistance, and the other where you will have a standard keyhole hysterectomy. You won't be able to choose which type of surgery you receive.

Throughout the study, you will have regular check-ups and assessments, which will be similar to the care you would receive outside of the study, but with additional data collection for research purposes. This will involve regular follow-up appointments after your surgery to monitor your recovery and any complications. The exact number and timing of these visits will be explained in detail by the study team, but generally, studies like this track patients for a period after surgery to assess long-term outcomes and safety.

Potential risks and benefits

Taking part in this study could potentially benefit you by offering a different surgical approach that might lead to fewer complications, although this is what the study aims to find out. You will also receive very close monitoring from a dedicated medical team. However, as with any surgery, there are potential risks involved, including those associated with anaesthesia and the surgical procedure itself. You might also experience side effects or complications from either surgical method. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Hôpital Privé de Provence
Verified postcode
Aix-en-Provence, France· Recruiting
Hôpital Privé le Bois
Verified postcode
Lille, France· Recruiting

Common questions

What is a hysterectomy?

A hysterectomy is a surgical operation to remove a woman's womb (uterus). It's done for various medical reasons, including endometriosis and adenomyosis.

What's the difference between keyhole and robot-assisted surgery?

Both are 'keyhole' (minimally invasive) surgeries, meaning small cuts are made. Robot-assisted surgery uses a surgeon-controlled robot to hold and move instruments, often allowing for more precise movements.

Why is this study only for women without digestive problems?

This study specifically focuses on endometriosis and adenomyosis that does not affect the digestive system to make sure the comparison between the two surgical methods is clear and focused on those specific conditions.

Will I get to choose which type of surgery I have?

No, if you join the study, you will be randomly assigned to receive either robot-assisted or standard keyhole hysterectomy. This ensures the results are fair and unbiased.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting the standard medical care you receive.

How to find out more

Pierre MD COLLINET

pierre.collinet@hotmail.fr 677707402 Official trial record

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