RecruitingOBSERVATIONAL

To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults

This research is investigating robotic surgery for both children and adults. Robotic surgery uses special machines to help surgeons operate with tiny cuts. It's becoming popular for adults, but less so for children. This study aims to understand if robotic surgery is a safe and effective option for younger patients, and how it compares in cost to regular surgery. Doctors believe robots can offer benefits like better precision, clearer vision for the surgeon, and less pain and quicker recovery for the patient, similar to traditional keyhole surgery. However, robotic systems are expensive, especially for children's hospitals. This study will carefully look at how well the robots perform and the overall costs involved.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

16,000

Start

28 Feb 2018

Estimated completion

01 Aug 2029

Surgery

What is this study about?

This study is all about understanding how well robotic surgery works for people of all ages, from children to adults. Robotic surgery involves using special machines that surgeons control to perform operations through very small cuts. You might hear this called 'minimally invasive surgery' or 'keyhole surgery'. For adults, this type of surgery is widely used already, but it's not as common in children's hospitals.

The main goal of this research is to see if using robots for surgery in children is safe and effective. They want to find out if it offers advantages over traditional methods, like less pain, faster recovery, and better cosmetic results with smaller scars. Surgeons who use robots believe these machines give them better control, clearer vision, and more precise movements, which could be especially helpful when operating in smaller areas, like inside a child's body.

Another important part of this study is to look at the cost. Robotic surgery systems and their upkeep can be very expensive. The researchers want to compare the costs of robotic surgery with traditional methods to get a full picture of its value, especially for children's hospitals that might have less access to these high-tech machines.

Key takeaways

Researches robotic surgery for kids and adults.
Aims to check safety, efficiency, and cost of robotic surgery.
Robots may offer benefits like better precision for surgeons.
Patients might experience less pain and quicker recovery.
Study also looks at the high cost of robotic equipment.
Suitable for patients needing surgery who can have the robotic option.

Who may be eligible?

To be considered for this study, you or your child would need to be scheduled for a surgery that could potentially be done with robotic assistance. This study welcomes both children and adults.

For children, your parents or guardians would need to agree to your participation. For adults, you would need to agree yourself.

However, if there are specific medical reasons, either related to your body (anatomy) or how you would react to anaesthesia, that make minimally invasive surgery unsuitable for you, then you wouldn't be able to join the study. These decisions would be made by your medical team.

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.

Am I, or my child, scheduled for surgery?
Could my surgery potentially be done with robotic assistance?
Does my medical team think I'm suitable for keyhole surgery?
For a child, do my parents or guardians agree to my participation?

Answer every question to see your result.

What does participation involve?

The study does not specify particular visits, assessments, or medications. If you or your child are eligible and agree to participate, your surgery would be performed using robotic assistance. The study would then collect information related to the surgery itself, such as how long it took, any complications, your recovery time, pain levels, and how long you stayed in the hospital. The overall duration of your participation would depend on your recovery, but the focus is on the surgical procedure and the immediate postoperative period.

Potential risks and benefits

Potential benefits of participating might include having your surgery performed with advanced robotic technology, which some believe can lead to smaller scars, less pain, and a faster recovery compared to traditional open surgery. However, there are also potential risks with any surgery, including robotic surgery, such as complications from anaesthesia, infection, or the need to switch to traditional open surgery during the procedure. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Hôpital Necker -Enfants Malades
Verified postcode
Paris, France· Recruiting

Common questions

What is robotic surgery?

Robotic surgery uses special machines controlled by a surgeon to perform operations through very small cuts, often called keyhole surgery.

Why is this study looking at children?

Robotic surgery is more common in adults than children. This study wants to see if it's safe and effective for younger patients and if it offers benefits for them too.

How to find out more

Thomas BLANC, MD, PhD

thomas.blanc@aphp.fr 01 44 49 41 53 Official trial record

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