Reconstruction in Extended MArgin Cancer Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Southampton NHS Foundation Trust
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients aged 18 or older
Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database)
Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study)
Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study)
Disqualifiers
Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery
Patients that undergo surgery by an intersphincteric abdominoperineal resection approach
Patients that are unable to complete the questionnaire over the telephone or online with a researcher
Patients unable or unwilling to provide informed consent
Trial population
Surgical patients undergoing abdominoperineal excision or pelvic exenteration for malignancies at thirteen hospitals in England.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biological mesh reconstruction
Procedure/SurgeryPatients receiving biological mesh of any kind or position as part of their reconstruction during surgery.
Myocutaneous flap reconstruction
Procedure/SurgeryPatients receiving a myocutaneous flap of any kind as part of their reconstruction during surgery.
Primary closure reconstruction
Procedure/SurgeryPatients receiving primary closure only using any suture material or technique as part of their reconstruction during surgery.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: Patients undergoing abdominoperineal excision3 interventions
Group B: Patient undergoing infralevator pelvic exenteration3 interventions
Trial outcomes
Primary outcomes
1
Work package 1
Morbidity for patients undergoing perineal reconstruction following abdominoperineal excision or pelvic exenteration, established by documenting empty pelvis syndrome complications and overall Clavien Dindo scores
Time frame
Data collection from prospectively maintained databases over 10 years2
Work package 2
Establishing quality of life in patients undergoing perineal reconstruction with for abdominoperineal excision and pelvic exenteration using The Global European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores. Note Global EORTC QLQ-C30 Score ranges from 0 - 100, with a higher score indicating a higher quality of life.
Time frame
12 months3
Work package 3
Undertake qualitative analysis from patients' accounts of their experiences in semi-structured interview, in order to complete a more complex evaluation of quality of life after pelvic exenteration and abdominoperineal resection.
Time frame
3 and 12 months post surgerySecondary outcomes
1
Work package 1
Patient overall and disease-free survival relating to perineal reconstruction.
Time frame
Retrospective data collection over 10 years2
Work package 1
Overall costs of perineal reconstructions and the complications that occurred as a result.
Time frame
Retrospective data collection over 10 years3
Work package 2
Longitudinal quality of life data (via The Global European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)) in patients undergoing abdominoperineal excision or pelvic exenteration, including disease specific quality of life modules, at 3-months, 6-months and 12-months post-surgery. Note that EORTC QLQ-C30 includes scores across functional scales and symptom scales / items, all scores are from 0 to 100, a higher score indicating a higher response level.
Time frame
12 months4
Work package 2
EQ-5D-5L(https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-5l/) will be measured before surgery and at 3,6,12-months after surgery. This is a validated, NICE recommended measure of QoL encompassing 5 domains: mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Southampton NHS Foundation Trust
Lead sponsor
Salisbury NHS Foundation Trust
Collaborator
University of Southampton
Collaborator
Dorset County Hospital NHS Foundation Trust
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
Mid Yorkshire Teaching NHS Trust
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
University Hospitals Dorset NHS Foundation Trust
Collaborator
Somerset NHS Foundation Trust
Collaborator
Swansea Bay University Health Board
Collaborator
Portsmouth Hospitals NHS Trust
Collaborator
Hampshire Hospitals NHS Foundation Trust
Collaborator
Royal Devon and Exeter NHS Foundation Trust
Collaborator
Sussex Partnership NHS Foundation Trust
Collaborator
London North West Healthcare NHS Trust
Collaborator
Manchester University NHS Foundation Trust
Collaborator
NHS Greater Glasgow and Clyde
Collaborator
The Christie NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov