NCT05219058

Brief 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. 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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
May 2022Jan 2028

First Submitted

Initial submission to the registry

January 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 31, 2025

Status Verified

July 1, 2024

Enrollment Period

4.3 years

First QC Date

January 20, 2022

Last Update Submit

January 29, 2025

Conditions

Surgery--ComplicationsPelvic CancerAbdominal CancerQuality of Life

Outcome Measures

Primary Outcomes (3)

  • 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

    Data collection from prospectively maintained databases over 10 years

  • 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.

    12 months

  • 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.

    3 and 12 months post surgery

Secondary Outcomes (10)

  • Work package 1

    Retrospective data collection over 10 years

  • Work package 1

    Retrospective data collection over 10 years

  • Work package 2

    12 months

  • Work package 2

    12 months

  • Work package 2

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Patients undergoing abdominoperineal excision

Abdominoperineal excision alone consists of removing only the rectum and anus

Procedure: Biological mesh reconstructionProcedure: Myocutaneous flap reconstructionProcedure: Primary closure reconstruction

Patient undergoing infralevator pelvic exenteration

Anterior pelvic exenteration includes resection of the structures of the anterior pelvis, namely the bladder, urethra and inner reproductive organs. Posterior pelvic exenteration comprises resection of the structures of the posterior pelvic cavity with reproductive organs and rectum, with or without the anal canal. Lateral compartment excision describes the resection of pelvic sidewall structures, such as the iliac vessels, piriformis and obturator internus muscles, and ischium, along with sacrotuberous and sacrospinous ligaments. Total pelvic exenteration entails removal of the bladder, urethra, inner reproductive organs, rectum, and anus with their muscles and ligaments. An infralevator pelvic exenteration includes the removal of the anus with their muscles and ligaments.

Procedure: Biological mesh reconstructionProcedure: Myocutaneous flap reconstructionProcedure: Primary closure reconstruction

Interventions

Biological mesh reconstructionPROCEDURE

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

Patient undergoing infralevator pelvic exenterationPatients undergoing abdominoperineal excision
Myocutaneous flap reconstructionPROCEDURE

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

Patient undergoing infralevator pelvic exenterationPatients undergoing abdominoperineal excision
Primary closure reconstructionPROCEDURE

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

Patient undergoing infralevator pelvic exenterationPatients undergoing abdominoperineal excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients undergoing abdominoperineal excision or pelvic exenteration for malignancies at thirteen hospitals in England.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Salisbury NHS Foundation Trust

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

RECRUITING

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

RECRUITING

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

NOT YET RECRUITING

Royal Devon University Healthcare NHS Foundation Trust

Cornwell, United Kingdom

NOT YET RECRUITING

Dorset County Hospital NHS Foundation Trust

Dorchester, United Kingdom

RECRUITING

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

NOT YET RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

RECRUITING

London North West University Healthcare NHS Trust

London, United Kingdom

NOT YET RECRUITING

Manchester University NHS Foundation Trus

Manchester, United Kingdom

NOT YET RECRUITING

The Christie NHS Foundation Trust

Manchester, United Kingdom

NOT YET RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

RECRUITING

University Hospitals Dorset NHS Foundation Trust

Poole, United Kingdom

RECRUITING

Portsmouth Hospitals University NHS Foundation Trust

Portsmouth, United Kingdom

RECRUITING

Swansea Bay University Health Board NHS Wales

Swansea, United Kingdom

NOT YET RECRUITING

Mid-Yorkshire Hospitals NHS Trust

Wakefield, United Kingdom

RECRUITING

Hampshire Hospitals NHS Foundation Trust

Winchester, United Kingdom

RECRUITING

Somerset NHS Foundation Trust

Yeovil, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Kashuf Khan, MBBS MRCS

    University Hospitals Southampton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles West, MBBS BSc

CONTACT

+442381208632charles.west4@nhs.net

Malcolm West, MD FRCS PhD

CONTACT

malcolm.west@uhs.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 1, 2022

Study Start

May 17, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

January 31, 2025

Record last verified: 2024-07

Locations

GB(18)