MIRRORS-FROZEN - a Pilot Randomised Controlled Trial (RCT) Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 2. Randomization acceptability
研究概览
简要总结
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.
详细描述
Open surgical staging is the current standard practice in managing women with complex adnexal masses suspicious of cancer. The diagnostic dilemma of early-stage ovarian cancer often leads to overtreatment by laparotomy in a number of patients with benign or borderline pathology.
MIRRORS-FROZEN (pilot) is a feasibility study that aims to establish whether the MIRRORS-FROZEN protocol can operate successfully and whether patients are willing to be recruited and randomized to either of the trial arms. The pilot trial also examines the feasibility and appropriateness of collecting a number of surgical, oncological, and patient-reported outcomes. The aim is to provide proof of concept that a larger, adequately powered multi-centre RCT is feasible.
Patients referred to the MDT with complex adnexal pelvic mass(es) or cyst(s) will be identified through the MDT meeting and screened against the eligibility criteria. Complex adnexal pelvic masses are defined as O-RADS-3 and deemed high risk of cancer as per subjective expert opinion, or O-RADS-4, O-RADS-5, and masses with an IOTA ADNEX score of ≥ 10%. As per standard practice, all patients referred with suspicious pelvic mass(es) will undergo a staging CT scan, serving as the primary screening tool to determine suitability for MIRRORS-FROZEN (pilot). In situations where MRI has been performed as staging imaging, the diameter of the cyst(s) or mass(es) will be used. The largest diameter of the cyst(s) or mass(es) should be ≤ 8 cm. In cases of bilateral masses or cysts, the larger cyst will be used to determine suitability for inclusion in the trial.
Potential participants will then be contacted by the trial coordinator or an appropriately trained member of the trial team to introduce the trial and provide the participant information leaflet and study consent form, along with the contact details of the trial team, at least 24 hours before the standard preoperative clinic appointment. Those who express interest in participating will undergo a comprehensive consent process conducted by an adequately trained member of the trial team. Following the consent process, baseline data collection will take place along with the baseline trial questionnaires.
All eligible participants who have consented to participate in the trial will be randomized using an online randomization service, Sealed Envelope™. Randomization will be at a ratio of 2:1 (MIRRORS-Frozen vs. standard treatment), using a simple randomization algorithm carried out by the trial coordinator/PI or a designated member of the trial team. After randomization and theatre allocation, participants will be contacted by a member of the trial team to inform participants of their allocation. No blinding or masking of allocation will occur, as both the participant and surgeon need to be aware of the allocation. The trial coordinator/PI and statistician will not be blinded to the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1: MIRRORS-FROZEN Protocol.
Initial 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.
干预措施: MIRRORS-FROZEN Protocol. (Procedure)
Arm 2 : Standard open surgery.
A midline abdominal incision will be made from the outset, with intraoperative frozen section assessment to determine the extent of the surgery.
干预措施: Standard open surgery (Procedure)
结局指标
主要结局
2. Randomization acceptability
时间窗: Through study completion, an average of 24-26 months
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
时间窗: Through study completion, an average of 24-26 months
Defined as the percentage of received responses out of the total number of responses sent at each assessment point defined by the trial protocol.
1. Recruitment Rate
时间窗: Through study completion, an average of 24-26 months
Defined as the percentage of patients who consent to participate out of the total number of patients offered inclusion in the study.
次要结局
- Rate of intra-operative cyst rupture with spillage within the peritoneal cavity(Through study completion, an average of 24-26 months)
- Rate of Conversion to open surgery(Through study completion, an average of 24-26 months)
- Blood Loss(Through study completion, an average of 24-26 months)
- Number of units of blood transfused(Through study completion, an average of 24-26 months)
- Intraoperative complications(Through study completion, an average of 24-26 months)
- Perioperative complications(Through study completion, an average of 24-26 months)
- Length of hospital stay(Through study completion, an average of 24-26 months)
- Days of ITU admission(Through study completion, an average of 24-26 months)
- Days to chemotherapy if indicated(Through study completion, an average of 24-26 months)
- Readmission rates(Through out the study and up to six weeks post- surgery)
- Cost of MIRRORS-FROZEN protocol vs standard open surgery.(Through out the study and up to six weeks post- surgery)
- Pain assessment(Through out the study and up to six weeks post- surgery)
- Quality of Life following surgery (generic)(Through out the study and up to six weeks post- surgery)
- Quality of Life following Surgery (cancer specific)(Through out the study and up to six weeks post- surgery)
- Mental wellbeing(Through out the study and up to six weeks post- surgery)
研究者
Radwa Hablase
Principal Investigator
Royal Surrey County Hospital NHS Foundation Trust