MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
MIRRORS "Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival" is a new United Kingdom based prospective feasibility study the purpose of which is to establish the feasibility of launching a British multicentre randomised control trial of Robotic interval debulking surgery for ovarian cancer (including cancer of the fallopian tube & peritoneum) in the future. This initial feasibility study will focus on the ability to recruit patients, acceptability, quality of life, the rate at which it is possible to remove all visible tumour and the rate of conversion to open surgery. Ultimately the investigators would like to determine whether, in selected patients, robotic surgery offers improved quality of life and recovery with equivalent overall and progression free survival.
Robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those with large pelvic masses or extensive disease around the upper part of the abdomen, however, it has the potential to provide significant recovery and quality of life benefits to a selected group of patients.
MIRRORS - ICG "Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in patients with advanced ovarian cancers" is a ancillary study within MIRRORS. Using ICG dye, the investigators aim to observe whether there are any changes in the blood vessel pattern associated with the tumour deposits the investigators remove that makes them distinctive. The ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in this ancillary research is not required for participation in the trial.
详细描述
Hypothesis
in selected cases of ovarian cancer, following neoadjuvant chemotherapy, minimally invasive robotic surgery provides maximal debulking surgery and improved patient outcomes.
Null Hypothesis: Robotic surgery is not suitable for the treatment of ovarian cancer following neoadjuvant chemotherapy. It is not possible to achieve maximal debulking surgery and patient outcomes are not improved.
To assess the feasibility of obtaining consent from women and acceptability of Robotic interval debulking surgery for advanced ovarian cancer. Women deemed suitable for interval debulking surgery will be identified through the Gynaecological Oncology multidisciplinary team meeting. The aim is to recruit women over a period of 1 year aiming for a total of 20 women who undergo Minimally Invasive Robotic Interval debulking surgery for advanced ovarian cancer. The main outcomes are feasibility of the recruitment process and acceptability of the questionnaires and numeric rating pain scale (NRS11) as assessed by completion rate and patient interviews.
In order to be able to offer MIRRORS to as many patients as possible the investigators have kept the inclusion criteria wide, not restricting by Body Mass Index (BMI), patient comorbidities or Ca125 level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women ≥18 years with Stage IIIc -IVb Ovarian cancer (including fallopian tube and peritoneal cancer) undergoing Neo-adjuvant Chemotherapy.
- •Considered suitable for Interval debulking surgery
- •≤8cm pelvic mass
- •MIRRORS ICG Inclusion Criteria - Same as above
排除标准
- •Pelvic mass >8cm, open surgical approach considered necessary following MDT review. Lacking capacity to the extent they are unable to understand or complete trial documentation / questionnaires.
- •MIRRORS ICG Exclusion criteria will be:
- •Severe renal insufficiency estimated Glomerular filtration rate (GFR)< 55ml/min, known allergy to iodine or Indocyanine green (ICG) and hyperthyroidism.
结局指标
主要结局
Recruitment
时间窗: Assessed at 1 year (recruitment period)
Number of patients consented compared to the number identified by multidisciplinary team as eligible for inclusion in the study expressed as a percentage. Success criteria: At least 20% of people eligible for the study will accept inclusion in the study.
次要结局
- Rate of Conversion to open surgery(Assessed at 1 year 3 months (once last recruited patient has undergone surgery))
- Mental wellbeing(3 months post surgery)
- Quality of Life following Surgery(3 months post surgery)
- Pain assessment(3 months post surgery)
- Surgical complications(Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) (Quarterly reports to be submitted to sponsor))
- Overall Survival(Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years)
- Cost(Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period))
- Robotic interval debulking - Maximal Macroscopic debulking rate (R=0 rate)(Assessed at 1 year 3 months (once last recruited patient has undergone surgery))
- Progression free survival(Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years)