Status:
RECRUITING
Reconstruction in Extended MArgin Cancer Surgery
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Salisbury NHS Foundation Trust
University of Southampton
Conditions:
Surgery--Complications
Pelvic Cancer
Eligibility:
All Genders
18+ years
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 ch...
Detailed Description
This is an observational multicentre retrospective and prospective cohort study, and a qualitative study. The project will have three working packages: * Work package 1 - maintenance of a colorectal ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT05219058
Start Date
May 17 2022
End Date
January 1 2028
Last Update
January 31 2025
Active Locations (18)
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1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
2
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, United Kingdom, SP2 8BJ
3
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
4
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom