Actively Recruiting

Age: 18Years +
All Genders
NCT05219058

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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