Reconstruction in Extended MArgin Cancer Surgery

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

NCT Number	NCT05219058
Lead Sponsor	University Hospital Southampton NHS Foundation Trust Collaborators: Salisbury NHS Foundation Trust, University of Southampton, Dorset County Hospital NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Mid Yorkshire Teaching NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospitals Dorset NHS Foundation Trust, Somerset NHS Foundation Trust, Swansea Bay University Health Board, Portsmouth Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, Sussex Partnership NHS Foundation Trust, London North West Healthcare NHS Trust, Manchester University NHS Foundation Trust, NHS Greater Glasgow and Clyde, The Christie NHS Foundation Trust
Conditions	Surgery--Complications, Pelvic Cancer, Abdominal Cancer, Quality of Life
Enrollment	236 participants
Start Date	2022-05-17
Primary Completion	2026-09-01 (estimated)
Study Completion	2028-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-01-31