Actively Recruiting
MIRRORS-FROZEN Pilot Trial Comparing Robotic and Open Surgery for Women with Complex Pelvic Adnexal Masses 8cm or Less
Led by Royal Surrey County Hospital NHS Foundation Trust · Updated on 2024-10-15
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Adnexal masses, which can develop in the ovaries or fallopian tubes due to various causes including hormone changes, infection, or cancer, may cause symptoms like pelvic discomfort or no symptoms at all. It is challenging to confirm cancer before surgery, and many masses turn out to be benign or slow-growing. This research compares robotic surgery to standard open surgery in women with complex adnexal masses eight centimeters or smaller, aiming to explore if robotic surgery can reduce the need for open surgery and assess outcomes for cancer patients. In this study, women with complex adnexal pelvic masses identified through imaging and expert assessment will be randomly assigned to one of two groups. One group will undergo an initial laparoscopic inspection followed by robotic removal of the mass if suitable, with frozen section analysis during surgery to guide further steps. The other group will have standard open surgery with a midline abdominal incision and similar frozen section assessment. Both groups may have further staging surgery depending on pathology results, including biopsies and removal of reproductive organs if needed. Participants will be followed for six weeks after surgery, completing questionnaires about quality of life, anxiety, depression, pain, and health economics. Data will be collected through electronic forms and emails, aligning with routine hospital visits to avoid extra appointments. The study aims to recruit 40 women over two years to assess recruitment feasibility, consent rates, questionnaire response rates, and surgical outcomes such as blood loss, complications, hospital stay, and recovery measures.
CONDITIONS
Brief Title
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Complex adnexal pelvic mass(es) 8 cm or smaller with no cancer outside the adnexae on CT or MRI
- Female, aged 18 to 100 years
- Able to provide signed written informed consent
You will not qualify if you...
- Adnexal pelvic mass larger than 8 cm
- Evidence of stage III or IV cancer by imaging or biopsy
- Unable to understand or give informed consent
- Not suitable for laparoscopic surgery, such as severe aortic stenosis
- Found to have disease beyond stage 1 after randomization and withdrawn from the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for preoperative clinic assessment and consent process
Duration - Surgical procedure day with variable length depending on surgical findings and decisions
Participants undergo either robotic surgery following the MIRRORS-FROZEN protocol or standard open surgery to remove complex pelvic adnexal masses and determine the extent of surgery based on intraoperative frozen section analysis.
1 surgical visit (in-person)
Duration - 6 weeks
Participants are monitored for recovery and surgical outcomes, including patient-reported quality of life, pain, and mental wellbeing, with data collected alongside routine hospital visits.
Visits aligned with routine hospital appointments; PROMs collected via email
Trial Site Locations
Total: 1 location
1
The Royal Surrey County Hospital NHS Foundation Trust.
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
Research Team
R
Radwa Hablase, MBBCh MRCOG PGCert
L
Laura Gordon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here