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NCT05696002 Clinical Trial

Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Rectal Cancer Clinical Trial

Official title:
Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05696002
Other study ID # APSOD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 14, 2023
Est. completion date January 1, 2030

Study information
Verified date January 2023
Source Glasgow Royal Infirmary
Contact Norman Galbraith, PhD MRCS
Phone 07449784948
Email norman.galbraith@glasgow.ac.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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..

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 1, 2030
Est. primary completion date January 1, 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Advanced pelvic oncological resection defined as more than 1 pelvic organ resected Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Academic Department of Surgery, Glasgow Royal Infirmary Glasgow

Sponsors (1)
Lead Sponsor Collaborator
Glasgow Royal Infirmary

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cancer-specific survival Months 10 years
Primary Overall survival Months 10 years
Primary Post-operative complications Frequency 10 years
Primary Quality of life (survey) Score 10 years
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