"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A pilot study looking at robotic surgery for ovarian cancer (MIRROR-RCT Pilot)
It is open to women who have:
And who are having chemotherapy before surgery (
These cancers are treated the same way. When we use the term ovarian cancer in this summary, we are referring to all 3.
More about this trial
The aim of surgery for advanced ovarian cancer is to remove as much as possible of the cancer. The standard way to do this is open surgery. To do this the surgeon makes a large cut down the middle of your tummy (abdomen).
Robotic surgery is similar to
The surgeon sits at a control unit a few feet away from the patient. They control the movement of a set of robotic surgical instruments, guided by a video camera. This is how they remove the cancer tissue. There is a surgical assistant by the bedside. It is the surgeon who does the surgery. With this type of surgery the surgeon makes several small cuts instead of one big cut.
Researchers are not sure what role robotic surgery has in ovarian cancer. It could have fewer side effects or complications than open surgery. To find this out they need to a
They have already done a feasibility study. The results show that it would be possible to do a randomised study. This pilot study is the next step before they do a large randomised clinical trial.
The aims of this pilot study are to find out:
- whether women are willing to take part in a randomised trial
- more about the role of robotic surgery in ovarian cancer
- more about the side effects and complications of robotic surgery
- more about the affect robotic surgery has on quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- have epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has spread outside the pelvis (stage 3c) or to another part of the body (stage 4)
- have a pelvic mass that is 8cm or less across as measured on a
CT scan. Your doctor will know this.
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply.
- You are not able to have surgery to remove as much visible disease as possible after chemotherapy.
- You need specialist surgical support to have surgery and the specialist team has recommended open surgery. Talk to your doctor about this.
This is a pilot study. The study team need about 20 women to take part.
It is a randomised study. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:
- laparoscopy group. You have a laparoscopy to decide whether you have robotic surgery or open surgery. You then have surgery straight away either by robotic surgery or open surgery depending on what the surgeon considers is best.
- open surgery group
Out of every 3 women who join the study, 2 will go into the laparoscopy group.
Everyone has a
You have keyhole (laparoscopic) surgery. The surgeon makes a small cut in your tummy (abdomen). Through the cut they put a small tube with a camera at the end to look at how much cancer they can see. They then decide whether you can have the robotic surgery or need open surgery to remove as much of the visible cancer as possible.
You have the standard open surgery to remove as much of the visible cancer as possible.
The study team will look at your medical records to get information about your surgery and the care after.
Quality of life
You fill in questionnaires before surgery and for a time after surgery. The team will tell you how often and when you need to fill in the questionnaires after surgery.
The questions ask about:
- whether you have pain or not
- what you are able to do
- your general health
These are quality of life questionnaires.
You see the doctor to discuss the study and see if you’d like to take part.
There are no extra hospital visits if you take part in the study.
The healthcare team monitor you during surgery and after surgery for any possible complications.
During your surgery if there are any complications it may be necessary for the surgeon to do open surgery.
Possible complications of ovarian cancer surgery include:
- bowel problems
- bladder problems
We have more information about ovarian cancer surgery.
How to join a clinical trial
Mr Simon Butler-Manuel
Royal Surrey NHS Foundation Trust
University of Surrey