Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal Cancer
APER
A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer
1 other identifier
observational
1,319
1 country
1
Brief Summary
The aim of the project is to evaluate the oncological and functional outcome of the more extensive perineal dissection - i.e the extra levator resection - in abdominoperineal resections in patients with rectal cancer. Hypothesis: Extra levator perineal resection reduces local recurrence three year postoperatively compared to traditional abdominoperineal resection and improves QoL 2-4 years postoperatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Typical duration 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
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 19, 2014
November 1, 2014
3.1 years
February 15, 2011
November 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year local recurrence
Local recurrence of rectal cancer 3 years after APR
3 years postoperatively
Secondary Outcomes (6)
Postoperative complications
30 days
Reoperation, readmittance and mortality
12 months
Late morbidity
24-48 months postoperatively
Quality of Life
24-48 months postoperatively
Health economy
24-48 months postoperatively
- +1 more secondary outcomes
Study Arms (2)
Extralevator APR
The perineal part of the APR is done with the intent to create a cylindrically shaped specimen thus removing part of or the entire levator muscle with the specimen.
Traditional APR
The perineal part of the APR is performed with the intent to remove the tumour with CRM free of tumour and the levator left in place.
Eligibility Criteria
All swedish patients registerd in the swedish rectalcancer registry undergoing APR 2007-2009
You may qualify if:
- Rectal cancer operated with APR 2007-2009
You may not qualify if:
- No informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sahlgrenska University Hospitallead
- Swedish Cancer Foundationcollaborator
Study Sites (1)
SSORG, Sahlgrenska Universitetssjukhuset, Område 2
Gothenburg, Västra Götalandsregionen, 416 85, Sweden
Related Publications (3)
Gonzalez E, Holm K, Wennstrom B, Haglind E, Angenete E. Self-reported wellbeing and body image after abdominoperineal excision for rectal cancer. Int J Colorectal Dis. 2016 Oct;31(10):1711-7. doi: 10.1007/s00384-016-2628-0. Epub 2016 Aug 10.
PMID: 27506432DERIVEDAsplund D, Prytz M, Bock D, Haglind E, Angenete E. Persistent perineal morbidity is common following abdominoperineal excision for rectal cancer. Int J Colorectal Dis. 2015 Nov;30(11):1563-70. doi: 10.1007/s00384-015-2328-1. Epub 2015 Aug 6.
PMID: 26245948DERIVEDPrytz M, Angenete E, Haglind E. Abdominoperineal extralevator resection. Dan Med J. 2012 Sep;59(9):A4366.
PMID: 22951192DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 16, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2014
Study Completion
June 1, 2014
Last Updated
November 19, 2014
Record last verified: 2014-11