Actively Recruiting
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
Eligibility Criteria
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)
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
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Your Study Journey
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
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
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
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
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
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
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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