AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.
This study, called AMBULAPSE, is exploring a new way to treat a common condition in women called pelvic organ prolapse. This is when organs like the bladder or womb drop down, causing discomfort. The standard treatment is keyhole surgery (laparoscopic sacrocolpopexy) to lift the organs back into place using a special mesh. This study specifically wants to see if this surgery can be done safely and effectively as a day-case procedure, meaning patients go home on the same day rather than staying in hospital overnight. Researchers are also looking at whether using robotic assistance during the surgery makes a difference. The goal is to find out how successful this day-case approach is and potentially pave the way for more women to have this surgery without needing a hospital stay.
At a glance
What is this study about?
You might have heard of pelvic organ prolapse, or perhaps you experience symptoms yourself. It's a common condition where organs in the pelvis, like the bladder, womb, or bowel, can slip down from their usual position. This can cause uncomfortable symptoms such as a feeling of heaviness, problems with bladder or bowel control, or discomfort during sex. It affects many women, and as people live longer, the number of women dealing with this is expected to grow.
The usual treatment for pelvic organ prolapse, especially when symptoms are bothersome, is an operation called a sacrocolpopexy. This is a type of keyhole surgery where a special mesh is used to lift and support the organs back into their correct place. This surgery generally works very well for most women, improving their symptoms significantly, and serious complications are uncommon.
Traditionally, after this type of surgery, women would stay in hospital for a few days to recover. However, this study is looking into whether it's safe and effective for women to have this surgery and go home on the same day, like a day-case procedure. This could make recovery more comfortable and convenient. The study is also comparing whether having the surgery with or without robotic assistance changes how well the day-case approach works. The information gathered will help doctors understand if day-case surgery for prolapse can become a standard option, potentially benefitting many more women in the future.
Key takeaways
- Exploring day-case keyhole surgery for pelvic organ prolapse.
- Aims for patients to go home the same day as their operation.
- Potentially convenient for women and healthcare.
- Compares surgery with and without robotic assistance.
- Aims to understand success rates for this approach.
Who may be eligible?
To join this study, women need to be between 40 and 80 years old, have significant pelvic organ prolapse (as diagnosed by a doctor on a specific scale), and generally be in good health. Your body mass index (BMI) should be under 30, and you shouldn't have any current urine infections.
However, there are reasons why you might not be able to join. For example, if you've had previous surgery for pelvic cancer or for prolapse before, or if you've had radiation treatment in your pelvic area, you wouldn't be eligible. Also, if you're pregnant or planning to get pregnant, or if you have certain health conditions like uncontrolled diabetes, high blood pressure, or serious heart or lung problems, you wouldn't be able to take part.
Other things that might prevent you from joining include allergies to certain medications (like Cefazoline), if you're taking specific blood-thinning medicines within 48 hours of the surgery, or if you have conditions like sleep apnea or certain psychiatric conditions that would make day-case care difficult. Your doctor will carefully review all of these points to see if the study is right for you.
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 a woman between 40 and 80 years old?
- Do you have significant pelvic organ prolapse symptoms and diagnosis?
- Is your BMI (Body Mass Index) under 30?
- Do you generally feel well and in good health for surgery?
- Have you NOT had pelvic cancer or prolapse surgery before?
What does participation involve?
If you join this study, you will undergo keyhole surgery (laparoscopic sacrocolpopexy) for your pelvic organ prolapse. The aim is for you to be discharged home on the same day as your surgery. After your surgery, you will have a follow-up visit with the study team about one month later to check on your recovery and how well the treatment worked using various health questionnaires and assessments. The total duration of your active participation in the study involves the surgery day and this one follow-up visit.
Potential risks and benefits
Locations (5)
- Hopital Antoine Beclere - AphpVerified postcodeClamart, France· Recruiting
- Chu de NantesVerified postcodeNantes, France· Recruiting
- CHU DE Nice - Hôpital l'ArchetVerified postcodeNice, France· Recruiting
- Ch Lyon SudVerified postcodePierre-Bénite, France· Recruiting
- Hopital FochVerified postcodeSuresnes, France· Recruiting
Common questions
What is pelvic organ prolapse?
It's when organs in your pelvis, like your bladder or womb, drop down from their normal position, causing symptoms like a heavy feeling or bladder problems.
What is day-case surgery?
Day-case surgery means you have your operation and go home on the same day, without staying in hospital overnight.
Will I have robots helping with my surgery?
The study is looking at surgery both with and without robotic help, so you might have either. Your doctor will explain which approach is planned for you.
How long will I be involved in the study?
Your main involvement will be the day of surgery and one follow-up visit about a month later.
What if I can't go home the same day?
The study defines success as going home the same day, but if medically necessary, you would stay in hospital overnight, just like with any other surgery.
How to find out more
Brannwel TIBI, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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