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
More than half of patients who have extensive surgery for advanced pelvic cancer develop a debilitating complication called Empty Pelvis Syndrome, where the empty cavity left behind becomes prone to infections, bowel blockages, and wound breakdown. This study follows 236 patients across 10 NHS centres for 12 months after their surgery, comparing two reconstruction techniques—using either a flap of the patient’s own muscle and skin or a biological mesh—to see which one better prevents these complications and improves quality of life. The researchers will also track NHS costs and patients’ out-of-pocket expenses, and interview 20 patients about their experiences and any hidden treatment side effects. If successful, the results will give surgeons and patients concrete data to weigh the trade-offs between reconstruction options during shared decision-making. This could reduce patient regret, improve recovery, and help the NHS allocate resources more efficiently. The findings may also influence international surgical guidelines and commissioning of cancer services, ultimately raising awareness of the long-term consequences of aggressive pelvic cancer treatment.
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Research Question What is the quality of life (QoL), complication rate and patient and NHS costs following extended margin cancer surgery (EMCS) and perineal reconstruction for advanced pelvic cancer? Background Advanced and recurrent pelvic cancers pose significant public health challenges due to their invasive nature, affecting vital pelvic structures like the pelvic floor, other organs, and the perineum. Treatment involves chemoradiotherapy followed by EMCS, to achieve cancer cure. EMCS results in an empty pelvis prone to major complications like collections, abscesses, bowel obstruction, fistulae, and perineal wound breakdown. Known as the Empty Pelvis Syndrome (EPS), this affects >50% of patients. EPS leads to poor QoL, reduced return-to-function and significant financial burden to patients and the NHS. Perineal reconstruction using myocutaneous flaps or biological meshes may mitigate these complications, but their longer-term clinical outcomes and effectiveness are not well-documented. This study addresses key unmet needs and aligns with strategic NHS priorities. Aim To assess the effects of EMCS on 12-month QoL, complications and health economic utilisation comparing perineal reconstruction groups. Objectives Provide real-world data on 12-month QoL and complications to aid shared decision-making consultations regarding reconstructive techniques post-ECMS. Inform clinical practice and patient expectations, improving communication and reducing regret throughout the initial stages of cancer survivorship. Evaluate economic impacts on patients and the NHS, optimising resource utilisation. Uncover hidden treatment toxicities post-ECMS. Methods Design: Multi-centre observational cohort study. Participants: 236 patients undergoing EMCS with either myocutaneous flap or biological mesh perineal reconstruction from 10 NHS cancer centres, ensuring diverse representation. Data Collection: Work Package(WP) 1: Patients will complete QoL (EORTC-QLQ-C30, EQ-5D-5L, LRRC-QoL) and Decision-Regret questionnaires pre-surgery and 3, 6, 12-months post-surgery. Patient economic impact (COST, patient employment, heath resource utilisation), quality-adjusted life years, incremental cost-effectiveness ratios(EQ-5D-5L) and NHS economic impact will be recorded over 12-months after surgery. Complications, pathology outcomes, survival, and cancer recurrence will also be recorded. WP 2: 20 purposefully selected patients, ensuring different ethnic representations, will be interviewed at 3 and 12-months post-surgery. Patient experiences including decision-making, complications, regret, and hidden cancer treatment toxicities will be explored. Analyses: WP1: EORTC-QLQ-C30 global health scores at 12-months will be compared between groups(primary outcome). Descriptive statistics, causal inference techniques, and regression modelling will be used. Propensity score weighting will estimate causal effects. Cost-utility economic analyses will compare reconstructive techniques. WP2: Longitudinal interview analyses will use constant comparative methods. Timelines The study will last 31 months, with 17 months for recruitment, 12 months follow-up, and 4 months data cleaning/analyses/reporting. Impact and Dissemination This study will benefit patients internationally by providing real-world outcomes to improve shared decision-making consultations, informing patient expectations and clinical outcomes for QoL, complications and cost after EMCS and perineal reconstruction. Results will be disseminated to researchers, healthcare professionals, patients, carers, charities and policymakers through online platforms, media, scientific conferences and journals. This will raise awareness of late effects of cancer treatment, influence international guidelines and cancer commissioning. Funding applications to charity partners and the NIHR will be submitted to develop a patient decision aid and conduct
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