None listed
Conditions
Brief summary
This study aims to assess the current use of robotic surgery for patients with locally advanced and recurrent pelvic cancer. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with locally advanced or recurrent pelvic cancer that requires extended resection (surgery to remove the lesions) and you are being treated at a centre where a robotic approach for surgery may be offered. Patients will be eligible regardless of whether they do or do not undergo surgery with a robotic approach. Study details This is an observational study, the decision to enrol in this study will not impact upon whether participants are, or are not offered surgery using a robotic approach. Participants who choose to enrol in this study will be asked to consent to their medical data being collected from their records, and will also be asked to complete a series of questionnaires about their quality of life and recovery post-surgery. It is anticipated that these questionnaires will be completed online usually and will take up to 30 minutes. Participants will be asked to complete these questionnaires at 4 timepoints, up to 1 year after their surgery. It is hoped this research will enable researchers to learn about the current use or robotic-assisted surgery, share their findings on techniques and help find out important information to plan and run a future trial to test the benefit of a robotic approach.
Interventions
This IDEAL 2B observational study will assess the current use of robotic assisted extended resection for locally advanced and recurrent pelvic malignancies. Patients being considered for a robotic approach with locally advanced or recurrent pelvic malignancy will be included in the study. This study is observational and so it will not change which treatment the patient receives.
INDICATION: Locally advanced or recurrent pelvic cancer requiring extended resection
PRIMARY OBJECTIVES:
To dete
This IDEAL 2B observational study will assess the current use of robotic assisted extended resection for locally advanced and recurrent pelvic malignancies. Patients being considered for a robotic approach with locally advanced or recurrent pelvic malignancy will be included in the study. This study is observational and so it will not change which treatment the patient receives. INDICATION: Locally advanced or recurrent pelvic cancer requiring extended resection PRIMARY OBJECTIVES: To determine the current case volume and current patient selection criteria of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres. SECONDARY OBJECTIVES: 1. To obtain pilot outcome data including clinical, pathological and patient reported outcome measures (PROMS). 2. To assess feasibility and plan a future prospective phase III randomised controlled trial of robotic versus non robotic extended resection in locally advanced or recurrent pelvic cancer. TRIAL DESIGN: Observational IDEAL 2B prospective study OBSERVATIONAL STUDY ARMS: Cases: Robotic extended resection for locally advanced or recurrent pelvic malignancy Controls: Non-robotic extended resection for locally advanced or recurrent pelvic malignancy For participants there will be no change to their treatment. Their data will be collected from medical records. They will be invited to participate in PROMS questionnaires at: 1. 7 days post operatively 2. 3 months 3. 6 months 4. One year Measures used will take approximately 30 minutes at each time point: Generic Measures: • EORTC QLQC30- This is a questionnaire specifically designed to assess the QOL of cancer patients. • QOR15- Quality of Recovery - This assesses patient quality of recovery after anaesthesia and surgery. • EQ5D – European Quality of Life-5 Dimensions Questionnaire – This questionnaire will enable health economic analysis Pain Scores • Verbal Numeric Rating Scale (VNRS) – to assess pain score at day 3 and day 7 post operatively and then at the same time points as the other PROMS. All participants being considered for a robotic approach with locally advanced or recurrent pelvic malignancy will be included in the study, and will be observed for up to 12 months post-enrolment. They will be consented to be contacted in the future and invited to participate in longer term follow up studies.
Sponsors
Satish Warrier
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with locally advanced or recurrent pelvic malignancy requiring extended resection 2. Patients in expert centres where a robotic approach is offered to selected cases with locally advanced or recurrent pelvic malignancy
Exclusion criteria
Patients who do not proceed to surgery.
Outcome results
None listed