Status:
UNKNOWN
Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
Lead Sponsor:
Royal Surrey County Hospital NHS Foundation Trust
Conditions:
Ovarian Cancer
Ovarian Neoplasm
Eligibility:
FEMALE
18+ years
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 esta...
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 Hypothes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 3 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04402333
Start Date
June 26 2020
End Date
October 3 2021
Last Update
September 2 2020
Active Locations (1)
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1
Royal Surrey NHS Foundation Trust
Guildford, Surrey, United Kingdom, GU2 7XX