Clinical trial Recruiting at 11 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment236 (estimated)
SponsorUniversity Hospital Southampton NHS Foundation Trust
Academic / other
Drugs / interventionschemotherapy
Locations18 sites (Southampton, Hampshire and 17 other locations)
StatusRecruiting
StartedMay 17, 2022
Main results expectedSeptember 1, 2026
Study endsJanuary 1, 2028
Registry record updatedJanuary 31, 2025
Trial IDNCT05219058 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.