NCT05219058 Reconstruction in Extended MArgin Cancer Surgery
| NCT ID | NCT05219058 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Condition | Surgery--Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 236 participants |
| Start Date | 2022-05-17 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 236 participants in total. It began in 2022-05-17 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Male and female patients aged 18 or older * Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database) * Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study) * Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study) Exclusion Criteria: * Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery * Patients that undergo surgery by an intersphincteric abdominoperineal resection approach * Patients that are unable to complete the questionnaire over the telephone or online with a researcher * Patients unable or unwilling to provide informed consent * Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service
Contact & Investigator
Kashuf Khan, MBBS MRCS
PRINCIPAL INVESTIGATOR
University Hospitals Southampton
Frequently Asked Questions
Who can join the NCT05219058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery--Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05219058 currently recruiting?
Yes, NCT05219058 is actively recruiting participants. Contact the research team at charles.west4@nhs.net for enrollment information.
Where is the NCT05219058 trial being conducted?
This trial is being conducted at Southampton, United Kingdom, Salisbury, United Kingdom, Basingstoke, United Kingdom, Brighton, United Kingdom and 11 additional locations.
Who is sponsoring the NCT05219058 clinical trial?
NCT05219058 is sponsored by University Hospital Southampton NHS Foundation Trust. The principal investigator is Kashuf Khan, MBBS MRCS at University Hospitals Southampton. The trial plans to enroll 236 participants.