Comparing open and robotic surgery for women with complex pelvic masses
Official 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.
Run by Royal Surrey County Hospital NHS Foundation Trust · NCT06638593 · Data updated 2026-11-12
This study is testing whether open surgery or robotic surgery is better for women with suspicious pelvic masses that are 8 cm or smaller.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Royal Surrey County Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (Guildford) |
| Status | Recruiting |
| Started | September 23, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06638593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 100 with complex adnexal masses measuring 8 cm or less and no evidence of malignant disease outside the adnexae.
✕Probably not a fit
Patients with adnexal masses larger than 8 cm or those with advanced-stage disease (stage III or IV) will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study, MIRRORS-FROZEN, aims to evaluate the feasibility of a new protocol for managing complex adnexal masses in women, specifically comparing open surgery to robotic surgery. Patients with masses that are 8 cm or smaller and deemed suspicious for cancer will be recruited and randomized to one of the two surgical approaches. The study will also assess various surgical, oncological, and patient-reported outcomes to determine the viability of conducting a larger multi-center randomized controlled trial in the future. The goal is to improve surgical management and reduce overtreatment in cases where masses are benign or borderline.
Why it matters
Potential benefit: If successful, this study could lead to more accurate surgical management of adnexal masses, potentially reducing unnecessary surgeries for benign conditions.
How similar studies have gone: While this approach is novel in its specific comparison of robotic versus open surgery for this indication, similar studies have shown promise in improving surgical outcomes for adnexal masses.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Complex adnexal Pelvic mass/es ≤8 cm with no malignant disease outside the adnexae on CT or MRI. * Women aged ≥18 \& ≤100 years old. * Patients who had given their signed and written informed consent Exclusion Criteria: * Adnexal pelvic mass \> 8 cm. * Radiological or histological or cytological evidence of stage III or IV disease. * Lack of capacity to understand and give informed consent. * Patients not suitable for laparoscopic surgery, such as but not limited to those with severe aortic stenosis. * Any patient randomized to either of the study arms and found to have disease which appears greater than stage 1 will be withdrawn from the trial and treated according to the national guidelines
Where it's running
-
The Royal Surrey County Hospital NHS Foundation Trust.
Guildford, United Kingdom Recruiting
Study contacts
- Study coordinator: Radwa Hablase, MBBCh MRCOG PGCert
- Email: r.hablase@nhs.net
- Phone: +441483688660
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.