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 cancer diagnosis will then have more surgical steps including assessment and sampling of various areas inside the abdomen (known as staging surgery) to see how far the cancer has spread.
Recovery after open surgery can be long and painful, with a slow return to normal daily activities. The trial investigators know from practice that robotic surgery has replaced open surgery for most benign adnexal diseases and other types of women's cancers, such as womb cancer. Recovery is quicker, with less pain and blood loss, allowing for a faster return to daily activities.
This study, MIRRORS-FROZEN (pilot), compares robotic versus the standard open surgery in managing women with complex adnexal masses of eight centimetres or less. The hope is to decrease the need for open surgery in patients with benign or borderline disease and to assess if robotic surgery has similar, worse, or better outcomes for patients with cancer.
MIRRORS-FROZEN is funded by Intuitive Foundation and GRACE Charity. The investigators will establish the feasibility of conducting a large multicentre randomized controlled trial in the future comparing certain cancer outcomes between robotic and open surgery.
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
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.
Parallel
MIRRORS-FROZEN Protocol.
Procedure/SurgeryInitial laparoscopic phase and thorough inspection of the abdomino-pelvic cavity to determine the feasibility of proceeding robotically, followed by robotic excision of the mass(es) and its retrieval in a bag if deemed suitable to proceed robotically. The mass or cyst will be sent for frozen section to determine the extent of the surgery. The surgery will continue robotically, with conversion to laparotomy considered at any point at the discretion of the individual surgeon.
Standard open surgery
Procedure/SurgeryA midline abdominal incision will be made from the outset, with intraoperative frozen section assessment to determine the extent of the surgery.
1. Recruitment Rate
Defined as the percentage of patients who consent to participate out of the total number of patients offered inclusion in the study.
2. Randomization acceptability
Defined as the percentage of participants who withdrew consent specifically due to randomization allocation, out of the total number of participants who initially consented.
3. Response rate to the trial questionnaires
Defined as the percentage of received responses out of the total number of responses sent at each assessment point defined by the trial protocol.
Rate of intra-operative cyst rupture with spillage within the peritoneal cavity
Defined as the percentage of cysts that rupture during surgery out of the total number of operations performed, both overall and within each treatment arm. At the beginning of surgery, the integrity of the cyst wall will be documented in both trial arms, accompanied by taking illustrative images. Before sending the cyst for frozen section analysis, a photographic image will be captured to confirm its wall status. Additionally, histological gross inspections conducted before frozen section analysis will be incorporated into both the frozen section results and the final histology report
Rate of Conversion to open surgery
The percentage of patients converted to open surgery after being deemed suitable for Robotic Surgery following the initial diagnostic laparoscopy, out of the total number of surgeries that begin as robotic procedures. ( only for MIRRORS-FROZEN arm).
Blood Loss
Blood Loss during surgery in millilitres - documented at the completion of the surgery in both arms - expressed as median and range.
Number of units of blood transfused
Number of units of blood transfused ( intraoperatively \& post operative) - documented on discharge for both trial arms - Expressed as median and range.
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