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

Qualifiers

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 design

Treatments tested in this trial

  • Biological mesh reconstruction
  • Myocutaneous flap reconstruction
  • Primary closure reconstruction

Treatment groups

236 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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