Investigating reconstruction methods after pelvic cancer surgery
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
This study looks at different ways to rebuild the body after pelvic cancer surgery to see how they affect recovery, quality of life, and healthcare costs for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 236 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 18 sites (Southampton, Hampshire and 17 other locations) |
| Trial ID | NCT05219058 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients undergoing pelvic cancer surgeries, specifically pelvic exenteration and abdominoperineal excision. It aims to collect and analyze data on complication rates, quality of life, and healthcare resource utilization associated with various reconstruction techniques. The study includes maintaining a comprehensive database, conducting a national collaborative study, and performing qualitative interviews to gather patient experiences. By evaluating these factors, the research seeks to enhance decision-making for patients and healthcare providers regarding reconstruction options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who have undergone pelvic exenteration or abdominoperineal excision at participating hospitals.
Not a fit: Patients who are unfit for surgery, decline the procedure, or are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing complex pelvic cancer surgeries.
How similar studies have performed: While similar studies have explored surgical outcomes in pelvic cancer, this specific approach to evaluating reconstruction techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Southampton, Hampshire and 17 other locations
- University Hospital Southampton NHS Foundation Trust — Southampton, Hampshire, United Kingdom (Recruiting)
- Salisbury NHS Foundation Trust — Salisbury, Wiltshire, United Kingdom (Recruiting)
- Hampshire Hospitals NHS Foundation Trust — Basingstoke, United Kingdom (Recruiting)
- University Hospitals Sussex NHS Foundation Trust — Brighton, United Kingdom (Not_yet_recruiting)
- Royal Devon University Healthcare NHS Foundation Trust — Cornwell, United Kingdom (Not_yet_recruiting)
- Dorset County Hospital NHS Foundation Trust — Dorchester, United Kingdom (Recruiting)
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Not_yet_recruiting)
- Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (Recruiting)
- London North West University Healthcare NHS Trust — London, United Kingdom (Not_yet_recruiting)
- Manchester University NHS Foundation Trus — Manchester, United Kingdom (Not_yet_recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Not_yet_recruiting)
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle, United Kingdom (Recruiting)
- University Hospitals Dorset NHS Foundation Trust — Poole, United Kingdom (Recruiting)
- Portsmouth Hospitals University NHS Foundation Trust — Portsmouth, United Kingdom (Recruiting)
- Swansea Bay University Health Board NHS Wales — Swansea, United Kingdom (Not_yet_recruiting)
- Mid-Yorkshire Hospitals NHS Trust — Wakefield, United Kingdom (Recruiting)
- Hampshire Hospitals NHS Foundation Trust — Winchester, United Kingdom (Recruiting)
- Somerset NHS Foundation Trust — Yeovil, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kashuf Khan, MBBS MRCS — University Hospitals Southampton
- Study coordinator: Charles West, MBBS BSc
- Email: charles.west4@nhs.net
- Phone: +442381208632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.