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

RecruitingNAAges 18 Years - 100 YearsFemaleRoyal Surrey County Hospital NHS Foundation Trust
NCT06638593 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Adnexal masses are growths that can form in the ovaries or fallopian tubes for different reasons, such as hormonal changes, infection, or cancer. These masses may cause pelvic discomfort, pain, constipation, or no symptoms at all. When adnexal masses are found on scans, they are described in a certain way to indicate if they could represent early-stage cancer, and the word "complex" is used to refer to these masses. Surgery is often recommended, where the mass is removed and examined under the microscope during surgery in a process called (frozen section analysis); to determine its true nature. It is still difficult to confirm cancer before surgery, and many of these masses turn out to be benign (not cancerous) or borderline (slow-growing tumours). Currently, doctors use open surgery with a cut from at least the belly button to the pubic bone to remove these masses. Patients with a canc

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📋 Eligibility rules (as published)
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Any patient randomized to either of the study arms and found to have disease which appears greater than stage 1 will be withdrawn from the trial and treated according to the national guidelines
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What it tests

  • MIRRORS-FROZEN Protocol.
  • Standard open surgery
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Where

1 site
The Royal Surrey County Hospital NHS Foundation Trust.
Guildford, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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