Reconstruction in Extended MArgin Cancer Surgery

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

Conditions

• Surgery--Complications
• Pelvic Cancer
• Abdominal Cancer
• Quality of Life

Interventions

PROCEDURE

Biological mesh reconstruction

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

PROCEDURE

Myocutaneous flap reconstruction

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

PROCEDURE

Primary closure reconstruction

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

Sponsors & Collaborators

• Salisbury NHS Foundation Trust

  collaborator OTHER_GOV

• University of Southampton

  collaborator OTHER

• Dorset County Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Mid Yorkshire Teaching NHS Trust

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• University Hospitals Dorset NHS Foundation Trust

  collaborator OTHER_GOV

• Somerset NHS Foundation Trust

  collaborator OTHER

• Swansea Bay University Health Board

  collaborator OTHER

• Portsmouth Hospitals NHS Trust

  collaborator OTHER_GOV

• Hampshire Hospitals NHS Foundation Trust

  collaborator OTHER

• Royal Devon and Exeter NHS Foundation Trust

  collaborator OTHER

• Sussex Partnership NHS Foundation Trust

  collaborator OTHER

• London North West Healthcare NHS Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• The Christie NHS Foundation Trust

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• Kashuf Khan, MBBS MRCS · University Hospitals Southampton

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-17

Primary Completion

2026-09-01

Completion

2028-01-01

Countries

• United Kingdom

Study Locations