A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery
1 other identifier
observational
1,000
1 country
1
Brief Summary
Minimally-invasive surgery (MIS) techniques have revolutionised the approach to rectal cancer surgery. With increasing experience, surgeons have began to utilise these platforms increasingly in the context of pelvic exenteration (PE). This observational retrospective review plans to assess the volume of PE being performed on a global basis and to assess the comparative outcomes associated with each technique in order to assess the optimal approach to radical pelvic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedOctober 20, 2021
October 1, 2021
4 months
June 24, 2021
October 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Resection status
Completeness of the surgical resection (R0, R1 or R2)
July 2016 - July 2021
Secondary Outcomes (7)
Blood loss
July 2016 - July 2021
Operation time
July 2016 - July 2021
Conversion rate
July 2016 - July 2021
Morbidity
July 2016 - July 2021
Length of stay
July 2016 - July 2021
- +2 more secondary outcomes
Study Arms (3)
Open
Patients who underwent an open approach to pelvic exenteration
Laparoscopic
Patients who underwent a laparoscopic approach to pelvic exenteration
Robotic
Patients who underwent a robotically-assisted pelvic exenteration
Eligibility Criteria
Patients over 18 years of age who are undergoing surgery for histologically-confirmed locally advanced or recurrent rectal cancer.
You may qualify if:
- Histologically proven locally advanced or recurrent RECTAL cancer
- Aged over 18 years
- Undergoing a multi-visceral extended pelvic resection
- Procedure took place within the specified timeframe (July 2016 - July 2021)
You may not qualify if:
- Extra-pelvic/ non-resectable metastatic or peritoneal disease
- Palliative pelvic exenteration
- Insufficient patient follow-up data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Vincent's Hospital
Dublin, D4, Ireland
Study Officials
- STUDY CHAIR
Desmond Winter, MD
St. Vincent's Healthcare Group
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Desmond C Winter
Study Record Dates
First Submitted
June 24, 2021
First Posted
July 2, 2021
Study Start
August 1, 2021
Primary Completion
December 1, 2021
Study Completion
February 1, 2022
Last Updated
October 20, 2021
Record last verified: 2021-10