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Reconstruction in Extended MArgin Cancer Surgery
Sponsor: University Hospital Southampton NHS Foundation Trust
Summary
Advanced pelvic cancers are uncommon, with treatment being challenging. Around 4000 patients every year need treatment in the UK. Cancers can involve multiple organs and often need radiotherapy and chemotherapy before surgery. Surgery usually requires removal of multiple pelvic organs, including muscles, bone, and skin around the anus (the perineum). This can lead to complications relating to both the empty pelvis syndrome and closure of the perineal defect. Reconstruction is challenging, with frequently occurring complications, reducing speed of recovery and quality of life. This study investigates complication frequency, quality of life and expenses following different reconstruction techniques. The investigators hope to improve patient and doctor decision-making in this area and find the best methods of reconstruction to improve outcomes. REMACS has three work packages: 1. Maintenance of a database of patients undergoing colorectal surgery at Southampton and Salisbury Hospitals, including those undergoing extra-levator abdominoperineal excision and pelvic exenteration. This includes all routinely collected clinical data, imaging, health resource use, and patient reported outcome measures. 2. A collaborative national prospective cohort study investigating morbidity, health resource use, longitudinal quality of life outcomes (EORTC QLQ-C30 and disease-specific modules) and quality adjusted life years. The investigators will also assess financial toxicity using the comprehensive score for financial toxicity. 3. A qualitative study using semi-structured interviews to undertake a more complex evaluation of quality of life and patient experiences in patients that have recovered from their surgeries. The last two work packages have now been funded by an NIHR Research for Patient Benefit Grant
Official title: REMACS - Understanding the Impact of Perineal Reconstruction After Extended MArgin Cancer Surgery on Longer-term Quality of Life, Morbidity and Health Economic Outcomes - a Prospective Longitudinal Cohort Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
236
Start Date
2022-05-17
Completion Date
2028-01-01
Last Updated
2025-01-31
Healthy Volunteers
No
Interventions
Biological mesh reconstruction
Patients receiving biological mesh of any kind or position as part of their reconstruction during surgery.
Myocutaneous flap reconstruction
Patients receiving a myocutaneous flap of any kind as part of their reconstruction during surgery.
Primary closure reconstruction
Patients receiving primary closure only using any suture material or technique as part of their reconstruction during surgery.
Locations (18)
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Cornwell, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
London North West University Healthcare NHS Trust
London, United Kingdom
Manchester University NHS Foundation Trus
Manchester, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, United Kingdom
Portsmouth Hospitals University NHS Foundation Trust
Portsmouth, United Kingdom
Swansea Bay University Health Board NHS Wales
Swansea, United Kingdom
Mid-Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Winchester, United Kingdom
Somerset NHS Foundation Trust
Yeovil, United Kingdom