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RecruitingNCT05696002Updated Jan 25, 2023

Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

An observational study in Rectal Cancer, Pelvic Cancer and Gynecologic Cancer, sponsored by Glasgow Royal Infirmary. Recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by Glasgow Royal Infirmary · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Sex
All
01

Study 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.

Read the 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..

02

Conditions studied

  • Rectal Cancer
  • Pelvic Cancer
  • Gynecologic Cancer
  • Colon Cancer

Keywords

  • Pelvic exenteration
  • Abdominoperineal resection
  • Reconstructive flap
  • Rectal cancer
03

In context

Rectal Neoplasms

2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.

This study's planned enrollment of 300 is above the median of 161 across 498 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Glasgow Royal Infirmary is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Tertiary referral centre

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Advanced pelvic oncological resection

    Complex resection

06

What researchers measure

Primary outcomes

  1. Cancer-specific survival

    Months

    Time frame: 10 years

  2. Overall survival

    Months

    Time frame: 10 years

  3. Post-operative complications

    Frequency

    Time frame: 10 years

  4. Quality of life (survey)

    Score

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Academic Department of Surgery, Glasgow Royal Infirmary
    Glasgow, United Kingdom
    Recruiting
    • Norman Galbraith, MSc PhD MRCS · Contact07449784948
    • Norman Galbraith, PhD MRCS · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Jan 2028, 59 months after the start.

Of 213 non-industry observational studies under Rectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 59 months is above that.

Counting every sponsor, half of 228 studies reached it within 45 months; a quarter within 24 and three quarters within 116.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2023
First posted
Jan 25, 2023
StartActual
Jan 14, 2023
Primary completionEst.
Jan 1, 2028
CompletionEst.
Jan 1, 2030
Last update
Jan 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05696002
Lead sponsor
Glasgow Royal Infirmary
Responsible party
Norman Galbraith (NES/CSO Clinical Lecturer in Surgery, Glasgow Royal Infirmary) — Principal investigator
First posted
Jan 25, 2023
Start date
Jan 14, 2023
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Jan 25, 2023

Study contacts

Norman Galbraith, PhD MRCS
Contact
norman.galbraith@glasgow.ac.uk
07449784948
Colin Steele, PhD FRCS
Contact
colin.steele@glasgow.ac.uk
07449784948
Colin Steele, PhD FRCS
study director · Glasgow Royal Infirmary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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