Reconstruction after advanced pelvic cancer surgery
| ISRCTN | ISRCTN81241096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81241096 |
| IRAS number | 282783 |
| ClinicalTrials.gov number | NCT05219058 |
| Secondary identifying numbers | CPMS 52006 |
- Submission date
- 29/01/2025
- Registration date
- 26/03/2025
- Last edited
- 01/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Advanced pelvic cancers affecting the bowel, anus, bladder, prostate and reproductive organs are challenging to treat. In the confined pelvic space, cancer easily spreads to nearby organs and muscles, sometimes invading the surrounding anal/genital skin (the perineum). The best chance of cure is radiotherapy, chemotherapy followed by major surgery. This life-changing surgery, called Extended Margin Cancer Surgery (EMCS), removes pelvic organs and the perineum leaving behind a large empty space. This can lead to complications like fluid buildup, infections, and wound breakdown, known as the empty pelvis syndrome. This syndrome affects over half of patients causing long-term health problems, poor quality of life(QoL) and placing a large financial burden on both patients and the NHS. To address these issues, surgeons perform perineal reconstruction using tissue flaps(muscle/skin taken from elsewhere in the body) or animal-derived meshes to fill the empty space and prevent complications. However, little is known about how different reconstruction methods impact QoL, complications, and costs after surgery. The aim of this study is to better understand the impact of different types of perineal reconstruction on QoL, complications and costs within the first 12 months after EMCS.
Who can participate
Patients over the age of 18 years with advanced rectal, anal, gynaecological, bladder, prostate, sarcoma, cancer invading the pelvic floor muscles, needing major surgery to remove the cancer and reconstruct the pelvic floor with either a tissue flap or a mesh.
What does the study involve
This study will recruit 236 patients from 10 NHS centres, ensuring a diverse population. Patients undergoing EMCS and flap or mesh perineal reconstruction will complete QoL questionnaires at recruitment, 3, 6 and 12 months after surgery. We will assess healthcare and patient resource use, financial burden, complications, survival, and cancer recurrence within 12- months after surgery. A selection of patients, ensuring different ages and ethnic representation, will be interviewed to explore the consequences of complications and their impact on QoL and decision-making.
Comparing QoL, complication rates and costs between the two surgical groups will provide valuable information for clinicians and patients, improving communication between patients and their clinical teams, thereby improving shared decisions and reducing regret.
What are the possible benefits and risks of participating?
The study will inform shared decision-making consultations with data captured from patients undergoing these operations as this currently does not exist. No risks for participation are identified.
Where is the study run from?
The study is coordinated from the University Hospital Southampton NHS Foundation Trust and the University of Southampton (UK)
When is the study starting and how long is it expected to run for?
December 2021 to January 2028
Who is funding the study?
National Institute for Health Research, Research for Patient Benefit (UK)
Who is the main contact?
1. A/Prof Malcolm West, M.West@soton.ac.uk
2. Prof. Alex Mirnezami
Contact information
Public, Scientific, Principal Investigator
University Hospital Southampton NHS Foundation Trust
South Academic Block
C-level, Tremona Road
Southampton
SO166YD
United Kingdom
 ORCID ID |
0000-0002-0345-5356 |
|---|---|
| malcolm.west@uhs.nhs.uk |
Study information
| Study design | Longitudinal observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | REMACS - understanding the impact of perineal reconstruction after extended margin cancer surgery on longer-term quality of life, morbidity and health economic outcomes - a prospective longitudinal cohort study |
| Study acronym | REMACS |
| Study hypothesis | Aim: To determine the effects of extended margin cancer surgery (EMCS), specifically comparing 12-month quality of life (QoL), complications and health economic utilisation between flap and mesh perineal reconstruction groups. |
| Ethics approval(s) |
Approved 10/03/2022, North East - Newcastle & North Tyneside 2 Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 22/NE/0032 |
| Condition | Advanced pelvic cancers |
| Intervention | Extended margin abdominopelvic cancer operations including abdominoperineal excision with pelvic reconstruction using biological mesh or myocutaneous flaps or primary closure. This study will recruit 236 patients from 10 NHS centres, ensuring a diverse population. Patients undergoing EMCS and flap or mesh perineal reconstruction will complete QoL questionnaires at recruitment, 3, 6 and 12 months after surgery. We will assess healthcare and patient resource use, financial burden, complications, survival, and cancer recurrence within 12- months after surgery. A selection of patients, ensuring different ages and ethnic representation, will be interviewed to explore the consequences of complications and their impact on QoL and decision-making. Comparing QoL, complication rates and costs between the two surgical groups will provide valuable information for clinicians and patients, improving communication between patients and their clinical teams, thereby improving shared decisions and reducing regret. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Quality of life is measured using the EORTC-QLQ-C30 generic global health at 12 months after surgery |
| Secondary outcome measures | 1. Quality of life is measured using the EORTC-QLQ-C30 generic and cancer-specific module at baseline before surgery and at 3, 6 and 12 months after surgery. 2. Quality of life is measured using the EQ-5D-5L at baseline before surgery and at 3, 6, and 12 months after surgery. 3. Decision-Regret will be measured using the Decision-Regret questionnaire at baseline before surgery and at 3, 6 and 12 months after surgery. 4. Specific quality of life for locally recurrent rectal cancer patients is measured using the LRRC-QoL at baseline before surgery and at 3, 6 and 12 months after surgery 5. Complications will be measured in-hospital and up to 12 months after surgery using the Clavien-Dindo score and Comprehensive Complication Index 6. Comparisons of costs and benefits, with financial toxicity measurements will be measured using the COST questionnaire at baseline before surgery and at 3, 6 and 12 months. 7. Quality-adjusted life years gained will be measured using the EQ-5D-5L at baseline before surgery and at 3, 6 and 12 months after surgery 8. Healthcare resource use data will be measured using unit costs from the National Schedule of NHS Costs will be used to cost resource use over the 12 months after surgery 9. Overall and disease-free survival will be measured at 12 months after surgery |
| Overall study start date | 01/12/2021 |
| Overall study end date | 01/01/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 236 |
| Participant inclusion criteria | 1. Male and female patients aged 18 years and over 2. Locally advanced or locally recurrent cancers arising from the rectum, uterus, ovary, cervix, anus, bladder, prostate, and sarcomas 3. Patients undergoing curative intent EMCS including infralevator pelvic exenteration(PE) or extralevator abdomino-perineal excision(ELAPE) 4. Patients undergoing perineal reconstruction with myocutaneous flap or biological mesh |
| Participant exclusion criteria | 1. Unfit, declined or not offered curative intent surgery 2. Inter-sphincteric abdominoperineal resection only 3. Patients undergoing perineal reconstruction with primary skin closure alone 4. Inability or unwillingness to provide informed consent |
| Recruitment start date | 17/05/2022 |
| Recruitment end date | 01/12/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Tonna Uchaf
Tonna
Neath
SA11 3LX
United Kingdom
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Swandean
Arundel Road
Worthing
BN13 3EP
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Sponsor information
Hospital/treatment centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| sponsor@uhs.nhs.uk | |
| Website | http://www.uhs.nhs.uk/home.aspx |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Findings will be shared with researchers, healthcare professionals, patients, carers, charities and policymakers through online platforms, media, scientific conferences and journals. PPI and charity partners will lead on dissemination. |
| IPD sharing plan | Fully anonymised data will be stored in a publicly available repository: https://register.clinicaltrials.gov/. Quality of life, heath economic and surgical outcomes data will be available. Patient-level data will not be made available but can be requested by a formal request to the study principal investigator. |
Editorial Notes
01/04/2025: Internal review.
29/01/2025: Study's existence confirmed by the HRA.
