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.
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Västra Götalandsregionen
-
Gothenburg, Västra Götalandsregionen, Sverige, 416 85
- SSORG, Sahlgrenska Universitetssjukhuset, Område 2
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Rectal cancer operated with APR 2007-2009
Exclusion Criteria:
- No informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
3-year local recurrence
Tidsramme: 3 years postoperatively
|
Local recurrence of rectal cancer 3 years after APR
|
3 years postoperatively
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative complications
Tidsramme: 30 days
|
postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis
|
30 days
|
|
Reoperation, readmittance and mortality
Tidsramme: 12 months
|
Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery
|
12 months
|
|
Late morbidity
Tidsramme: 24-48 months postoperatively
|
Late morbidity and functional disorders: prolonged wound healing, late infections, limping, pain, sitting problems, urinary incontinence, erectile dysfunction, stoma related dysfunction
|
24-48 months postoperatively
|
|
Quality of Life
Tidsramme: 24-48 months postoperatively
|
Patient experienced health and QoL 24-48 months postoperatively
|
24-48 months postoperatively
|
|
Health economy
Tidsramme: 24-48 months postoperatively
|
Health economy analysis of resource consumption
|
24-48 months postoperatively
|
|
Stoma function
Tidsramme: 24-36 months postop
|
Assessment of stoma function related both to construction and surgical technique and patient position
|
24-36 months postop
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SSORG APER
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .