NCT04402333

Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival

MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Royal Surrey County Hospital NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Ovarian Neoplasm
• Ovarian Neoplasm Epithelial
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
PROCEDURE	Robotic Interval Debulking Surgery	Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.

Timeline

• Start date: 2020-06-26
• Primary completion: 2021-10-03
• Completion: 2021-10-03
• First posted: 2020-05-26
• Last updated: 2020-09-02

Locations

1 site across 1 country: United Kingdom