Comparing open and robotic surgery for women with complex pelvic masses
MIRRORS-FROZEN - a Pilot Randomised Controlled Trial (RCT) Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Royal Surrey County Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (Guildford) |
| Trial ID | NCT06638593 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guildford
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.