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
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Low rectal cancer treated surgically by abdominoperineal resection (APR) has worse outcome than other rectal cancers operated with low anterior resection. In order to improve the outcome in the APR group a more extensive surgical procedure - the extra levator APR - has been suggested. This study aims to investigate both the oncological and the functional outcome of this method as compared to the traditional APR.
Method: All Swedish patients undergoing abdominoperineal resection for rectal cancer 2007-2009 will be analysed regarding operative technique (traditional or extra levator resection). Data on all patients regarding pre op TNM classification, pathological report and local recurrence will be collected from the Swedish Rectal Cancer registry. A validated QoL form will be sent to each patient to further investigate the functional outcome, health economy and Quality of Life 2-4 years postoperatively.
Data will be analysed regarding 3 year recurrence rate (primary endpoint) as well as functional result and QoL (secondary endpoints) in the two different groups - i.e traditional and extra levator APR.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Västra Götalandsregionen
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Gothenburg, Västra Götalandsregionen, Zweden, 416 85
- SSORG, Sahlgrenska Universitetssjukhuset, Område 2
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Rectal cancer operated with APR 2007-2009
Exclusion Criteria:
- No informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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3-year local recurrence
Tijdsspanne: 3 years postoperatively
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Local recurrence of rectal cancer 3 years after APR
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3 years postoperatively
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Postoperative complications
Tijdsspanne: 30 days
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postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis
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30 days
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Reoperation, readmittance and mortality
Tijdsspanne: 12 months
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Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery
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12 months
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Late morbidity
Tijdsspanne: 24-48 months postoperatively
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Late morbidity and functional disorders: prolonged wound healing, late infections, limping, pain, sitting problems, urinary incontinence, erectile dysfunction, stoma related dysfunction
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24-48 months postoperatively
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Quality of Life
Tijdsspanne: 24-48 months postoperatively
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Patient experienced health and QoL 24-48 months postoperatively
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24-48 months postoperatively
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Health economy
Tijdsspanne: 24-48 months postoperatively
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Health economy analysis of resource consumption
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24-48 months postoperatively
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Stoma function
Tijdsspanne: 24-36 months postop
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Assessment of stoma function related both to construction and surgical technique and patient position
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24-36 months postop
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Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Algemene publicaties
- 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.
- Asplund 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.
- Prytz M, Angenete E, Haglind E. Abdominoperineal extralevator resection. Dan Med J. 2012 Sep;59(9):A4366.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SSORG APER
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