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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Västra Götalandsregionen
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Gothenburg, Västra Götalandsregionen, Sverige, 416 85
- SSORG, Sahlgrenska Universitetssjukhuset, Område 2
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Rectal cancer operated with APR 2007-2009
Exclusion Criteria:
- No informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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3-year local recurrence
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SSORG APER
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