- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01323166
Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques (APR)
Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Low rectal cancer treated by abdominoperineal resection (APR, rectal amputation)has worse prognosis than other rectal cancers, both regarding local recurrence and cancer specific survival. With a view to improve local recurrence rates a more extensive perineal operation (excision of the levator muscle) has been suggested. In our university hospital thie technique was introduced for all surgeons January 2007. A population of all patients operated from 1 January 2007 to 31 December 2009 was compared to all patients operated from 1 January 2004 to 31 December 2006 using the traditional, less extensive method, in all a six year period and 158 patients.
A specific questionnaire was developed after in depth interviews, and was face-validated by patients who had undergone an APR. This questionnaire will be sent out to all patients in our population who are still alive.
The patients will be contacted first by a letter of invitation, later called by telephone to be given more information and asked for permission to send the questionnaire.
The send out of invitation letters will start March 2011.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Gothenburg, Sverige, SE 416 85
- Dept. of Surgery, Sahlgrenska University Hospital/Ostra
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- rectal cancer operated by abdominoperineal resection 2004-2009
Exclusion Criteria:
- no informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Excision of the levator muscle
The abdominal part of the operation is performed as an TME and the perineal part of the operation is performed with the intent to get a cylindrical specimen thus removing part of or the entire levator muscle with the specimen
|
Cylindrical perineal excision including the levator muscle
Andre navn:
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Traditional perineal operation
The abdominal part of the operation performed as a TME.
The perineal operation performed with the intent of removing the tumour with CRM free of tumour and the levator left in place
|
Cylindrical perineal excision including the levator muscle
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
Tidsramme: 2-7 years after operation
|
A detailed questionnaire with 250 questions, where emphasis is on physical satisfaction and emotional status as well as bowel function, sexual function and stoma function 2-7 years after rectal amputation
|
2-7 years after operation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Impact of rectal cancer surgery on household finances in a long-term perspective
Tidsramme: 2-7 years after operation
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Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.
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2-7 years after operation
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Impact of rectal cancer surgery and the level of intrusive thoughts
Tidsramme: 2-7 years after operation
|
Part of the questionnaire analyses occurrence and effects of intsrusice thoughts
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2-7 years after operation
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Eva Angenete, MD,PhD, Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
Publikasjoner og nyttige lenker
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
- QoL after APR at SU
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