Ovarian Cancer Clinical Trial
Official title:
MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
MIRRORS "Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer,
Recovery & Survival" is a new United Kingdom based prospective feasibility study the purpose
of which is to establish the feasibility of launching a British multicentre randomised
control trial of Robotic interval debulking surgery for ovarian cancer (including cancer of
the fallopian tube & peritoneum) in the future. This initial feasibility study will focus on
the ability to recruit patients, acceptability, quality of life, the rate at which it is
possible to remove all visible tumour and the rate of conversion to open surgery. Ultimately
the investigators would like to determine whether, in selected patients, robotic surgery
offers improved quality of life and recovery with equivalent overall and progression free
survival.
Robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those
with large pelvic masses or extensive disease around the upper part of the abdomen, however,
it has the potential to provide significant recovery and quality of life benefits to a
selected group of patients.
MIRRORS - ICG "Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in
patients with advanced ovarian cancers" is a ancillary study within MIRRORS. Using ICG dye,
the investigators aim to observe whether there are any changes in the blood vessel pattern
associated with the tumour deposits the investigators remove that makes them distinctive. The
ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in
this ancillary research is not required for participation in the trial.
Hypothesis: in selected cases of ovarian cancer, following neoadjuvant chemotherapy,
minimally invasive robotic surgery provides maximal debulking surgery and improved patient
outcomes.
Null Hypothesis: Robotic surgery is not suitable for the treatment of ovarian cancer
following neoadjuvant chemotherapy. It is not possible to achieve maximal debulking surgery
and patient outcomes are not improved.
To assess the feasibility of obtaining consent from women and acceptability of Robotic
interval debulking surgery for advanced ovarian cancer. Women deemed suitable for interval
debulking surgery will be identified through the Gynaecological Oncology multidisciplinary
team meeting. The aim is to recruit women over a period of 1 year aiming for a total of 20
women who undergo Minimally Invasive Robotic Interval debulking surgery for advanced ovarian
cancer. The main outcomes are feasibility of the recruitment process and acceptability of the
questionnaires and numeric rating pain scale (NRS11) as assessed by completion rate and
patient interviews.
In order to be able to offer MIRRORS to as many patients as possible the investigators have
kept the inclusion criteria wide, not restricting by Body Mass Index (BMI), patient
comorbidities or Ca125 level.
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