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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Gothenburg, Zweden, SE 416 85
- Dept. of Surgery, Sahlgrenska University Hospital/Ostra
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- rectal cancer operated by abdominoperineal resection 2004-2009
Exclusion Criteria:
- no informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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
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Cylindrical perineal excision including the levator muscle
Andere namen:
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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
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Cylindrical perineal excision including the levator muscle
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
Tijdsspanne: 2-7 years after operation
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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
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2-7 years after operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Impact of rectal cancer surgery on household finances in a long-term perspective
Tijdsspanne: 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
Tijdsspanne: 2-7 years after operation
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Part of the questionnaire analyses occurrence and effects of intsrusice thoughts
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2-7 years after operation
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Eva Angenete, MD,PhD, Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
Publicaties en nuttige links
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
- QoL after APR at SU
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