Brief Title
Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
Official Title
MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
Brief Summary
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.
Detailed Description
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.
Study Type
Observational
Primary Outcome
Recruitment
Secondary Outcome
Quality of Life following Surgery
Condition
Ovarian Cancer
Intervention
Robotic Interval Debulking Surgery
Study Arms / Comparison Groups
Robotic interval debulking surgery
Description: Surgery will commence with an initial assessment with a camera inserted though the belly button. This visual assessment will be used to determine whether it is feasible to proceed with surgery robotically or whether full debulking surgery to zero macroscopic residual disease would be best carried out through an open surgical approach. If an open surgical approach is considered the optimum treatment for the patient and they have consented for this, then this will be done. If there is disease that cannot be removed Robotically after starting by this route, but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so. If there are any complications, we may also need to convert to open surgery. The aim of the surgery whether by robotic or open is to remove all visible disease safely.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
40
Start Date
June 26, 2020
Completion Date
October 3, 2021
Primary Completion Date
October 3, 2021
Eligibility Criteria
Inclusion Criteria:
Adult women ≥18 years with Stage IIIc -IVb Ovarian cancer (including fallopian tube and
peritoneal cancer) undergoing Neo-adjuvant Chemotherapy.
Considered suitable for Interval debulking surgery
≤8cm pelvic mass
MIRRORS ICG Inclusion Criteria - Same as above
Exclusion Criteria:
Pelvic mass >8cm, open surgical approach considered necessary following MDT review. Lacking
capacity to the extent they are unable to understand or complete trial documentation /
questionnaires.
MIRRORS ICG Exclusion criteria will be:
Severe renal insufficiency estimated Glomerular filtration rate (GFR)< 55ml/min, known
allergy to iodine or Indocyanine green (ICG) and hyperthyroidism.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Simon Butler-Manuel, MD, 07958143884, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04402333
Organization ID
MIRRORS
Responsible Party
Sponsor
Study Sponsor
Royal Surrey County Hospital NHS Foundation Trust
Study Sponsor
Simon Butler-Manuel, MD, Principal Investigator, Royal Surrey NHS Foundation Trust
Verification Date
August 2020