Actively Recruiting

Age: 18Years +
All Genders
ID05219058

REMACS - Impact of Perineal Reconstruction After Extended Margin Cancer Surgery on Quality of Life, Complications, and Health Costs A Prospective Longitudinal Cohort Study

Led by University Hospital Southampton NHS Foundation Trust · Updated on 2025-01-31

236

Participants Needed

18

Research Sites

69 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

Researchers are studying advanced pelvic cancers, which are rare and often require complex treatment involving radiotherapy, chemotherapy, and surgery. Surgery typically involves removing multiple pelvic organs and surrounding tissues, which can lead to complications affecting recovery and quality of life. This study aims to investigate the frequency of these complications, quality of life, and related costs following different reconstruction techniques to help improve decision-making for patients and doctors. This observational study has three parts: maintaining a database of patients undergoing colorectal surgery, conducting a national prospective cohort study to assess morbidity, quality of life, and healthcare resource use, and a qualitative study using interviews to explore patient experiences after surgery. Patients undergoing surgeries like abdominoperineal excision or pelvic exenteration will be followed, with reconstruction methods chosen by the surgeon. Data such as surgery details, complications, and resource use will be collected and analyzed. Participants will complete quality of life and financial impact questionnaires at baseline, 3, 6, and 12 months after surgery, either by telephone or email. Clinical data, imaging, and hospital resource use will also be recorded. The qualitative study will involve interviews with selected patients at 3 and 12 months post-surgery to deepen understanding of recovery and long-term outcomes. The study will analyze these data to evaluate the impact of different reconstruction methods on patient health and healthcare costs over time.

CONDITIONS

Brief 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 undergone pelvic exenteration or abdominoperineal excision at participating sites with complete data (work package 1)
  • Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2)
  • Patients who have had pelvic exenteration or abdominoperineal resection and can speak English (work package 3)
Not Eligible

You will not qualify if you...

  • Patients who are eligible but unfit, decline, or are not offered abdominoperineal excision or pelvic exenteration surgery
  • Patients who undergo surgery by an intersphincteric abdominoperineal resection approach
  • Patients unable to complete questionnaires by telephone or online with a researcher
  • Patients unable or unwilling to provide informed consent
  • Patients who are prisoners or under probation supervision

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to confirm eligibility and provide study information

Baseline Assessments

Duration - Up to 1 week before surgery

Participants complete baseline quality of life and financial questionnaires and provide clinical information before surgery.

1 visit (in-person) for questionnaire completion and clinical data collection

Surgery

Duration - Surgery day and index hospital admission

Participants undergo abdominoperineal excision or pelvic exenteration surgery with reconstruction at the surgeon's discretion.

Hospital stay including surgery and immediate recovery

Post-operative Follow-up

Duration - Up to discharge from hospital

Participants have clinical data collected on hospital stay, complications, and healthcare resource use after surgery.

Continuous monitoring during hospital stay

Follow-up Assessments

Duration - 12 months post-surgery

Participants complete quality of life, financial, and healthcare resource questionnaires at 3, 6, and 12 months after surgery, with clinical data reviewed.

1 to 3 telephone or email contacts at 3, 6, and 12 months post-surgery

Qualitative Interviews

Duration - 3 and 12 months post-surgery

A subset of participants are invited to participate in semi-structured interviews at 3 and 12 months post-surgery to discuss their experiences.

1 to 2 interviews (telephone or in-person) depending on participant availability

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

M

Malcolm West, MD FRCS PhD

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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