Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
MIRRORS
MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedStudy Start
First participant enrolled
June 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2021
CompletedSeptember 2, 2020
August 1, 2020
1.3 years
May 11, 2020
August 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Recruitment
Number of patients consented compared to the number identified by multidisciplinary team as eligible for inclusion in the study expressed as a percentage. Success criteria: At least 20% of people eligible for the study will accept inclusion in the study.
Assessed at 1 year (recruitment period)
Secondary Outcomes (9)
Quality of Life following Surgery
3 months post surgery
Mental wellbeing
3 months post surgery
Pain assessment
3 months post surgery
Surgical complications
Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) (Quarterly reports to be submitted to sponsor)
Rate of Conversion to open surgery
Assessed at 1 year 3 months (once last recruited patient has undergone surgery)
- +4 more secondary outcomes
Study Arms (2)
Robotic interval debulking surgery
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.
Open interval debulking surgery
Standard Care. Following initial laparoscopic assessment patients not deemed suitable for minimally invasive robotic surgery will proceed with standard open interval debulking surgery through an extended midline incision. These patients will also be followed up to assess recovery, complication rate and quality of life.
Interventions
Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.
Eligibility Criteria
Suitable participants will be identified during the Royal Surrey NHS Foundation Trust Gynaecological Oncology multidisciplinary team meeting (MDT).
You may qualify if:
- 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
You may not qualify if:
- 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.
- Severe renal insufficiency estimated Glomerular filtration rate (GFR)\< 55ml/min, known allergy to iodine or Indocyanine green (ICG) and hyperthyroidism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Surrey NHS Foundation Trust
Guildford, Surrey, GU2 7XX, United Kingdom
Biospecimen
Tumour tissue samples from patients undergoing robotic interval debulking surgery and open interval debulking surgery. Analysis will involve primarily immunohistochemistry but may include extracting Ribonucleic acid (RNA).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Butler-Manuel, MD
Royal Surrey NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2020
First Posted
May 26, 2020
Study Start
June 26, 2020
Primary Completion
October 3, 2021
Study Completion
October 3, 2021
Last Updated
September 2, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share