RecruitingNCT05219058

Reconstruction in Extended MArgin Cancer Surgery

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


Sponsor

University Hospital Southampton NHS Foundation Trust

Enrollment

236 participants

Start Date

May 17, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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)

Exclusion Criteria5

  • 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
  • Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service

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Interventions

PROCEDUREBiological mesh reconstruction

Patients receiving biological mesh of any kind or position as part of their reconstruction during surgery.

PROCEDUREMyocutaneous flap reconstruction

Patients receiving a myocutaneous flap of any kind as part of their reconstruction during surgery.

PROCEDUREPrimary closure reconstruction

Patients receiving primary closure only using any suture material or technique as part of their reconstruction during surgery.


Locations(18)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Salisbury NHS Foundation Trust

Salisbury, Wiltshire, United Kingdom

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Royal Devon University Healthcare NHS Foundation Trust

Cornwell, United Kingdom

Dorset County Hospital NHS Foundation Trust

Dorchester, United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

London North West University Healthcare NHS Trust

London, United Kingdom

Manchester University NHS Foundation Trus

Manchester, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

University Hospitals Dorset NHS Foundation Trust

Poole, United Kingdom

Portsmouth Hospitals University NHS Foundation Trust

Portsmouth, United Kingdom

Swansea Bay University Health Board NHS Wales

Swansea, United Kingdom

Mid-Yorkshire Hospitals NHS Trust

Wakefield, United Kingdom

Hampshire Hospitals NHS Foundation Trust

Winchester, United Kingdom

Somerset NHS Foundation Trust

Yeovil, United Kingdom

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