Actively Recruiting

All Genders
ID05696002

Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Led by Glasgow Royal Infirmary · Updated on 2023-01-25

300

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to observe and report outcomes for patients undergoing advanced pelvic oncological surgery for malignancies such as rectal, pelvic, gynecologic, and colon cancers. The study includes complex surgeries like multi-visceral resections, beyond total mesorectal excision, sacrectomy, flap reconstruction, and urinary reconstruction. Its purpose is to understand major complications, the natural course of these surgical patients, and to identify areas for future interventional studies. The study is observational and includes patients undergoing advanced pelvic oncological resections involving more than one pelvic organ. There are no experimental treatments or interventions administered; instead, it collects data on patients who have had these complex surgeries. The study is conducted at Glasgow Royal Infirmary and includes both retrospective and prospective data collection. Participants will be followed for up to 10 years to assess cancer-specific survival, overall survival, postoperative complications, and quality of life through surveys. The study involves collecting medical records and patient-reported outcomes to monitor these long-term results. This extensive follow-up aims to provide detailed information about the outcomes and complications after advanced pelvic cancer surgeries.

CONDITIONS

Brief Title

Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing advanced pelvic oncological resection involving more than one pelvic organ
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay duration as per clinical care

Participants undergo advanced pelvic oncological resection including complex multi-organ surgery and immediate post-operative care.

Visits as required during hospital stay

Post-operative Follow-up

Duration - Up to 10 years

Participants are followed long-term to monitor cancer-specific survival, overall survival, post-operative complications, and quality of life.

Follow-up visits scheduled according to clinical care up to 10 years

Trial Site Locations

Total: 1 location

1

Academic Department of Surgery, Glasgow Royal Infirmary

Glasgow, United Kingdom

Actively Recruiting

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Research Team

N

Norman Galbraith, PhD MRCS

C

Colin Steele, PhD FRCS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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