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Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Sponsor
Glasgow Royal Infirmary (Other)
Overall Status
Recruiting
CT.gov ID
NCT05696002
Collaborator
(none)
300
Enrollment
1
Location
83.6
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

    Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Advanced Pelvic Surgical Oncology Database - Prospective Observational Study
    Actual Study Start Date :
    Jan 14, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2028
    Anticipated Study Completion Date :
    Jan 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Advanced pelvic oncological resection

    Complex resection

    Outcome Measures

    Primary Outcome Measures

    1. Cancer-specific survival [10 years]

      Months

    2. Overall survival [10 years]

      Months

    3. Post-operative complications [10 years]

      Frequency

    4. Quality of life (survey) [10 years]

      Score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Advanced pelvic oncological resection defined as more than 1 pelvic organ resected
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academic Department of Surgery, Glasgow Royal Infirmary Glasgow United Kingdom

    Sponsors and Collaborators

    • Glasgow Royal Infirmary

    Investigators

    • Study Director: Colin Steele, PhD FRCS, Glasgow Royal Infirmary

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norman Galbraith, NES/CSO Clinical Lecturer in Surgery, Glasgow Royal Infirmary
    ClinicalTrials.gov Identifier:
    NCT05696002
    Other Study ID Numbers:
    • APSOD
    First Posted:
    Jan 25, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norman Galbraith, NES/CSO Clinical Lecturer in Surgery, Glasgow Royal Infirmary
    Pelvic exenteration
    Abdominoperineal resection
    Reconstructive flap
    Rectal cancer
    Additional relevant MeSH terms:
    Rectal Neoplasms
    Pelvic Neoplasms

    Study Results

    No Results Posted as of Jan 25, 2023