Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

January 13, 2023 updated by: Norman Galbraith, Glasgow Royal Infirmary

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 Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • Recruiting
        • Academic Department of Surgery, Glasgow Royal Infirmary
        • Contact:
          • Norman Galbraith, MSc PhD MRCS
          • Phone Number: 07449784948
        • Principal Investigator:
          • Norman Galbraith, PhD MRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary referral centre

Description

Inclusion Criteria:

  • Advanced pelvic oncological resection defined as more than 1 pelvic organ resected

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Advanced pelvic oncological resection
Complex resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-specific survival
Time Frame: 10 years
Months
10 years
Overall survival
Time Frame: 10 years
Months
10 years
Post-operative complications
Time Frame: 10 years
Frequency
10 years
Quality of life (survey)
Time Frame: 10 years
Score
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glasgow Royal Infirmary

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2023

Primary Completion (Anticipated)

January 1, 2028

Study Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Estimate)

January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APSOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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