
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This study is looking at preventing ovarian cancer in women at increased risk by removing the fallopian tubes first and then the ovaries at a later date.
You are at an increased risk of developing ovarian cancer if you:
or
The for women who have an increased risk of ovarian cancer is surgery to remove their fallopian tubes and ovaries at the same time. Doctors call this a risk reducing salpingo oophorectomy (RRSO).
A large number of women usually have this surgery before the . By removing the ovaries early they go through early onset menopause. And this can have some health concerns including:
Some women delay having or don’t have RRSO surgery to avoid early menopause and its potential problems.
Current research suggests that many ovarian cancers start in the fallopian tubes.
Researchers think that a 2 stage operation might be better than RRSO. The first stage is to remove the fallopian tubes. The second stage is to remove the ovaries with another operation later. This might give women another choice apart from RRSO to reduce their risk of ovarian cancer. This is particularly helpful for women who delay or prefer not to have RRSO especially before the menopause.
But it isn’t known by how far the risk of ovarian cancer might be reduced by removing the fallopian tubes first.
Doctors call this new 2 stage surgery a risk reducing early salpingectomy and delayed oophorectomy (RRESDO).
In this study you can choose to have either:
The aims of the study are to find out:
The following bullet points list 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 you are a woman at risk of developing ovarian because:
or
or
And all of the following apply. You:
In order to join one of the surgical arms of the study (RRSO or RRESDO) you must have completed having your family. You can join the ‘no surgery’ arm if you have not yet completed having your family.
Who can’t take part
You cannot join this study if any of these apply. You:
The team need 1,000 women to join the study. There are 3 groups (cohorts) in this study. You choose which group you go into. The groups are:
RRESDO
This is the new 2 stage operation to prevent ovarian cancer. In the first stage you have your fallopian tubes removed. In the second stage you have your ovaries removed.
You choose when to have your ovaries removed at a later date after the first operation. You might choose to have your ovaries removed before you go through the menopause naturally. If not, then you should have this done after you have gone through the menopause.
Should you choose to have your ovaries removed before going through the menopause your doctor will talk to you about having hormone replacement therapy ().
Before your RRESDO surgery.
This is the standard treatment for women at risk of ovarian cancer. You have both your fallopian tubes and ovaries removed at the same time.
Before your RRSO surgery.
You can choose at any time to have either RRESDO or RRSO surgery during the study. Let your study doctor know and they will tell you about the operations.
Surgery
For all the operations you have a .
Where possible the surgeons do this as . This means you have small cuts instead of one large cut in your tummy (abdomen). You stay in hospital for a day. Recovery after the operation takes about 1 to 2 weeks. After this you should be able to do you normal daily activities.
For a number of reasons a small number of women can’t have keyhole surgery. Instead you have surgery using a large cut in your tummy (abdomen). You need to stay in hospital for 5 days. Recovery after the operation takes 6 weeks. After this you should be able to do you normal daily activities.
During the operation the surgeon takes tissue (fallopian tubes and ovaries) and some fluid (washings) from your tummy. The surgeon sends these to the laboratory so that a specialist called a can look at the cells under a microscope. They look for any signs that the cells in the tissue and fluid are abnormal, pre cancer or cancer.
If they find pre cancer or cancer cells your doctor will refer you to a specialist in women’s cancer (gynaecological oncologist).
For women who haven’t gone through the menopause your doctor will talk to you about having hormone replacement therapy (HRT) after your operation.
Interviews
The team will interview a small number of women. They will ask about:
The interview takes about an hour and will be recorded.
The team interview women in the surgery groups again a year after their operation. This is to find out:
This interview will also be recorded.
You don’t have to answer any questions if you don’t want to. You can also stop the interview at any time.
You don’t have to agree to do the interview. You still can take part in the study.
Quality of life
You fill in a few questionnaires:
The questions ask about:
You see the doctor to have some tests before taking part. These tests include:
If you are having RRSO or RRESO surgery, you see the doctor after having your operation at:
Women having RRESDO have another ultrasound and some blood tests before your second operation.
After you have the second operation (delayed oophorectomy) you see the doctor at:
Control (no operation)
You see the doctor:
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
All surgery can have risks and complications. These can include:
• wound infections and urine infections
• blood clot in the leg (DVT) or in the lung (pulmonary embolism)
• chesty cough (chest infection)
• damage to the bowel, bladder or tubes that drain the urine (ureters)
Having 2 separate operations can also increase your risk of getting complications.
After having surgery to prevent ovarian cancer there is a small risk you might still develop cancer of the peritoneum called peritoneal cancer.
Early menopause
There are some possible effects when you have an early menopause. These include:
Your doctor or a member of the study team will talk to you about the possible risks of surgery and early menopause before you agree to join the study.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Ranjit Manchanda
Queen Mary University of London
Barts and the London Charity
Rosetrees Trust
The Eve Appeal
Ovarian Cancer Action
Ovacome
BRCA Umbrella
Target Ovarian Cancer
NCRI Gynaecological Cancer Clinical Studies Group
GO Girls
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”