Actively Recruiting
Reconstruction in Extended MArgin Cancer Surgery
Led by University Hospital Southampton NHS Foundation Trust · Updated on 2025-01-31
236
Participants Needed
18
Research Sites
293 weeks
Total Duration
On this page
Sponsors
U
University Hospital Southampton NHS Foundation Trust
Lead Sponsor
S
Salisbury NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Reconstruction in Extended MArgin Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 or older
- Patients who have had pelvic exenteration or abdominoperineal excision at participating sites with complete data
- Patients scheduled for pelvic exenteration or abdominoperineal excision at participating sites
- Patients who have already had pelvic exenteration or abdominoperineal resection and can speak English
You will not qualify if you...
- Patients eligible but unfit, who decline, or are not offered abdominoperineal excision or pelvic exenteration surgery
- Patients undergoing intersphincteric abdominoperineal resection surgery
- Patients unable to complete questionnaires over the telephone or online with a researcher
- Patients unable or unwilling to provide informed consent
- Patients who are prisoners or offenders supervised by probation services
AI-Screening
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Trial Site Locations
Total: 18 locations
1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
2
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, United Kingdom, SP2 8BJ
Actively Recruiting
3
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
Actively Recruiting
4
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
Not Yet Recruiting
5
Royal Devon University Healthcare NHS Foundation Trust
Cornwell, United Kingdom
Not Yet Recruiting
6
Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom
Actively Recruiting
7
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Not Yet Recruiting
8
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Actively Recruiting
9
London North West University Healthcare NHS Trust
London, United Kingdom
Not Yet Recruiting
10
Manchester University NHS Foundation Trus
Manchester, United Kingdom
Not Yet Recruiting
11
The Christie NHS Foundation Trust
Manchester, United Kingdom
Not Yet Recruiting
12
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Actively Recruiting
13
University Hospitals Dorset NHS Foundation Trust
Poole, United Kingdom
Actively Recruiting
14
Portsmouth Hospitals University NHS Foundation Trust
Portsmouth, United Kingdom
Actively Recruiting
15
Swansea Bay University Health Board NHS Wales
Swansea, United Kingdom
Not Yet Recruiting
16
Mid-Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom
Actively Recruiting
17
Hampshire Hospitals NHS Foundation Trust
Winchester, United Kingdom
Actively Recruiting
18
Somerset NHS Foundation Trust
Yeovil, United Kingdom
Actively Recruiting
Research Team
C
Charles West, MBBS BSc
CONTACT
M
Malcolm West, MD FRCS PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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