MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.

Launched by ROYAL SURREY COUNTY HOSPITAL NHS FOUNDATION TRUST · Oct 10, 2024

Keywords

ClinConnect Summary

The MIRRORS-FROZEN trial is studying the best way to remove complex growths in the ovaries or fallopian tubes, which are known as adnexal masses, that are 8 centimeters or smaller. These masses can sometimes be benign (not cancerous) or borderline (slow-growing), but they may also indicate early-stage cancer. Currently, the standard procedure is open surgery, which involves a larger cut and can lead to longer recovery times and more pain. This trial is comparing open surgery to robotic surgery, which is less invasive and may allow for quicker recovery and less discomfort.

Women aged 18 to 100 who have complex adnexal masses of 8 cm or less and have no signs of cancer outside the ovaries may be eligible to participate in this study. Participants will have the opportunity to receive either type of surgery, and doctors will monitor their recovery and outcomes. The goal of this trial is to see if robotic surgery can provide similar or better results compared to open surgery, especially for those with cancer. The trial is currently recruiting participants and aims to set the groundwork for a larger study in the future.

Gender

FEMALE

Eligibility 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Any patient randomized to either of the study arms and found to have disease which appears greater than stage 1 will be withdrawn from the trial and treated according to the national guidelines