MIRRORS – FROZEN (Pilot) V1.2
Research type
Research Study
Full title
MIRRORS-FROZEN A pilot randomised controlled trial (RCT) comparing open Vs robotic surgery in the management of women with complex pelvic adnexal masses ≤ 8cm.
IRAS ID
336767
Contact name
Simon Butler-Manuel
Contact email
Sponsor organisation
Royal Surrey County Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Adnexal masses, arising from the ovaries or fallopian tubes, occur at any age and may result from physiological changes, endometriosis, or cancer. Complex adnexal mass or cyst is a radiological description, and although most are not cancers, they raise serious clinical concerns about early cancer. The majority are found by chance on scans done for other reasons, as they cause no or non-specific gynaecological symptoms. Women with such masses are referred to tertiary centres for evaluation by Multidisciplinary Teams (MDTs) using imaging features and blood markers. Scoring systems like IOTA ADNEX and O-RADS aid in distinguishing masses. However, accurate preoperative classification as cancerous or not can be challenging.
As a result, most patients undergo comprehensive staging surgery through a vertical midline abdominal cut. Such surgery is associated with morbidity and often prolonged recovery, especially since ovarian cancer patients are usually older and may be frail.
MIRRORS-FROZEN is a feasibility pilot randomized controlled trial investigating the role of robotic surgery in managing complex pelvic adnexal masses ≤ 8 cm. The trial combines robotic surgery with intraoperative frozen section analysis to tailor the extent of the surgery required. This approach will allow patients to reap the benefits associated with robotic surgery, including reduced blood loss, fewer complications, and faster recovery, without, it is hoped, compromising cancer treatment for those diagnosed. We aim to recruit 40 patients over two years to evaluate the feasibility of recruitment and randomization among patients, providing proof of concept that a larger, adequately powered multi-centre RCT is feasible. If non-inferiority of robotic assessment and staging surgery is confirmed, this would lead to a significant change in practice, potentially offering safer, less invasive surgery to a wider group of patients. The gynaecology oncology team at the Royal Surrey County Hospital NHS Foundation Trust will run the trial.
REC name
West of Scotland REC 4
REC reference
24/WS/0094
Date of REC Opinion
13 Aug 2024
REC opinion
Further Information Favourable Opinion