“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A study looking at robotic surgery for ovarian cancer (MIRRORS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Ovarian cancer
Status:
Closed
Phase:
Other
This study is looking at whether robotic surgery has a role in treating advanced ovarian cancer.
Advanced ovarian cancer is cancer that has spread into the tummy (abdomen), to the 
or to another part of the body.
More about this trial
Advanced ovarian cancer is usually treated with chemotherapy initially to shrink the cancer followed by surgery to remove the cancer and then further chemotherapy. This surgery is usually performed as a laparotomy (open surgery). This involves making a large cut in your abdomen to remove the cancer.
Robotic surgery is like a (also known as key-hole surgery). You have a few small cuts in your abdomen. The surgeon puts the instruments through these small cuts. One is a thin tube with a light and camera, this allows the surgeon to see where the cancer is. They then use the instruments to remove the cancer.
Surgeons need to have special training before they can carry out this type of surgery. It involves 2 machines. The patient unit and the control unit.
The patient unit has 4 arms. One arm holds the camera and the others hold the surgical instruments.
The patient unit is controlled by the control unit. The control unit is where the surgeon sits. It is in the operating theatre with you but is separate from the patient unit.
The surgeon can see the operating area on a screen. This gives the surgeon a 3D view that they can magnify up to 10 to 12 times.
Below the screen are the controls. The surgeon uses these master controls to move the instruments on the patient unit.
This turns any movements the surgeon makes into much smaller movements of the machine. It also reduces any shaking, allowing the surgeon to make very tiny, accurate movements. Cutting and putting in stitches is easier with the robotic assistance.
Having a few small cuts is less painful, improves recovery after surgery and reduces the length of stay in hospital. It also can reduce the risks and possible complications of surgery.
Researchers think that robotic surgery might be better than open surgery to remove ovarian cancer. But they aren’t sure. To find out they need to compare them in a large .
Before they can do a randomised trial, they need to find out if women are willing to take part and whether the robotic surgery is acceptable. This is a feasibility study.
The aims of this feasibility study are to find out the:
- number of women willing to take part
- effect of robotic surgery on their
quality of life - number of robotic surgeries that are completed as open surgery
- number of women who complete the study questionnaires
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 ovarian cancer that has spread into the tummy (abdomen), to the lymph nodes or to another part of the body (stage 3c or stage 4)
- have an area of cancer between the hip bones (pelvis) that is 8cm or less across
- can have surgery to remove as much cancer as possible
- are having chemotherapy before surgery
- can understand and complete the study questionnaires
- are at least 18 years old
Who can’t take part
You cannot join this study if you need to have open surgery for another reason such as liver surgery. Your doctor will know if this applies to you.
Trial design
This is a feasibility study. The team need 20 women to have the robotic surgery.
You have a before your operation.
At the start of your operation you have a laparoscopy. Your surgeon puts a thin tube with a light and camera (laparoscope) through a small cut in your abdomen. This is to see how much cancer there is. The surgeon then makes the decision whether you can have the robotic surgery or need to have the open surgery to remove the cancer.
During the robotic surgery if the surgeon can’t remove all the cancer they will continue with open surgery if it is safe to do so. They might also need to do open surgery if there are complications when doing the robotic surgery.
The team look at your medical notes to find out the details of your surgery, chemotherapy and any further treatment.
You fill in a questionnaire before surgery:
- after surgery
- 3 weeks after surgery
- 3 months after surgery
The questions ask about your quality of life and experience of surgery.
The team also interview you after surgery to find out more about your experience of surgery. The team record this to analyse later. They keep all your details and answers confidential.
Indocyanine Green (ICG) dye study
Indocyanine green is a dye doctors use to assess the lymph nodes. You have it as a .
In this study the team want to use the dye to look at the pattern of blood vessels in the sheet of tissue that covers the abdomen. This is called the peritoneum. They want to see what the pattern of blood vessels is like where the cancers are.
After the injection of the dye the team will look at your abdomen and pelvic area under normal light to see where the cancer is. They then use an infrared light. This makes the dye glow and they can see the blood vessel pattern around the cancers.
After your operation they will look and record if any of the cancer areas removed glowed under the infrared light.
You don’t have to take part in this dye study if you don’t want to. You can still take part in the main study.
Tissue samples
The researchers will use the tissue samples from your surgery to compare the difference between cancers removed by robotic surgery and open surgery. They will also look at how well chemotherapy works for using these samples.
Hospital visits
There are no extra hospital visits if you take part in this study.
Side effects
All surgery has risks and can have complications. The risks and possible complications of this type of surgery include:
- risk of infection in the urine, wound or chest
- injury to the bowel, bladder or ureters
- problems with breathing and the heart
After surgery for advanced ovarian cancer whether it is open surgery or robotic surgery you might need to have an opening (stoma) from your bowel to the outside on your abdomen. Over the stoma is a bag to collect your poo. This may be temporary or permanent.
Your doctor or a member of the study team will talk to you about the possible risks and complications before you agree to take part.
We have information about surgery to remove ovarian cancer.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Mr Simon A. Butler-Manuel
Supported by
GRACE Charity (Gynae-oncology Research and Clinical Excellence)
Royal Surrey NHS Foundation Trust
Freephone 0808 800 4040
Last review date
CRUK internal database number:
17303
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
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