Investigating reconstruction methods after pelvic cancer surgery
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
Run by University Hospital Southampton NHS Foundation Trust · NCT05219058 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 236 (estimated) |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 18 sites (Southampton, Hampshire and 17 other locations) |
| Status | Recruiting |
| Started | May 17, 2022 |
| Main results expected | September 1, 2026 |
| Study ends | January 1, 2028 |
| Registry record updated | January 31, 2025 |
| Trial ID | NCT05219058 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older who have undergone pelvic exenteration or abdominoperineal excision at participating hospitals.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar studies have explored surgical outcomes in pelvic cancer, this specific approach to evaluating reconstruction techniques is relatively novel.
Who can join: the full rules
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 it's running
-
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 -
Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom Recruiting -
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom Recruiting -
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom Recruiting
Show 12 more locations
-
University Hospitals Dorset NHS Foundation Trust
Poole, United Kingdom Recruiting -
Portsmouth Hospitals University NHS Foundation Trust
Portsmouth, United Kingdom 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 -
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 -
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom Not yet 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 -
Swansea Bay University Health Board NHS Wales
Swansea, United Kingdom Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Assessing energy dynamics and postoperative outcomes in cancer surgery
This study is testing a new way to check how well patients with esophageal and lung cancer can handle surgery by measuring their energy levels before the operation to see if it affects their recovery afterwards.
-
Next Generation Delivery System (NGDS) for SBRT in thorax and upper abdomen
A study tests a new machine to deliver SBRT more quickly and comfortably for adults with thoracic or upper abdominal cancers.
-
Does preoperative physical activity help predict perioperative problems after non-cardiac surgery?
This study tests whether self-reported physical activity before surgery adds to existing risk factors in predicting complications and death after elective non-cardiac surgery.
-
Breath-hold technique to improve radiation accuracy for abdominal cancers
This study tests whether using inhale and exhale breath holds during SBRT can better target abdominal tumors while protecting nearby organs.
-
Complications after ankle arthroscopy
The team will follow adults who've had ankle arthroscopy to see what complications they experience in the year after surgery.
-
Heated versus aerosolized chemotherapy delivered into the abdomen for cancer that has spread to the peritoneum
This study will test whether heated (HIPEC) or aerosolized (PIPAC) mitomycin-based chemotherapy given into the abdomen works better and is safer for adults whose cancer has spread to the peritoneum.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.