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Reconstruction in Extended MArgin Cancer Surgery

Study acronym: REMACS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 31, 2025 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment target: 100 to 236 Study sites: 2 to 18 · Completion date: Sep 1, 2027 to Jan 1, 2028 · Secondary endpoints: 8 to 10 · 2 morev8 Show 5 more changesShow less
    • Study sites: 2 to 18
    • Completion date: Sep 1, 2027 to Jan 1, 2028
    • Secondary endpoints: 8 to 10
    • Study description expanded, about 204 words
    • Collaborators: 9 to 17

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria shortened, about 12 wordsv7 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Oct 1, 2024 to Sep 1, 2026 Completion date: Oct 1, 2025 to Sep 1, 2027 · Secondary endpoints: details revised at 1 of 8 entries · Study description shortened, about 40 words · 1 morev6 Show 4 more changesShow less
    • Completion date: Oct 1, 2025 to Sep 1, 2027
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description shortened, about 40 words
    • Collaborators: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  4. Collaborators: 1 to 8v5 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Oct 1, 2023 to Oct 1, 2024 Completion date: Oct 1, 2024 to Oct 1, 2025 · Secondary endpoints: 9 to 8 · Study description shortened, about 17 words · 1 morev4 Show 4 more changesShow less
    • Completion date: Oct 1, 2024 to Oct 1, 2025
    • Secondary endpoints: 9 to 8
    • Study description shortened, about 17 words
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2022 to May 17, 2022 · Site details revised at 2 of 2 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2022 to May 17, 2022
    • Site details revised at 2 of 2 sites
  2. Secondary endpoints: details revised at 3 of 9 entries Study description expanded, about 19 wordsv2 Show 1 more changeShow less
    • Study description expanded, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05219058
Lead Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators: Salisbury NHS Foundation Trust, University of Southampton, Dorset County Hospital NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Mid Yorkshire Teaching NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospitals Dorset NHS Foundation Trust, Somerset NHS Foundation Trust, Swansea Bay University Health Board, Portsmouth Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, Sussex Partnership NHS Foundation Trust, London North West Healthcare NHS Trust, Manchester University NHS Foundation Trust, NHS Greater Glasgow and Clyde, The Christie NHS Foundation Trust
Conditions Surgery--Complications, Pelvic Cancer, Abdominal Cancer, Quality of Life
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov