Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques (APR)

3. september 2015 opdateret af: Eva Angenete, Sahlgrenska University Hospital, Sweden

Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life

The purpose of the study is to compare self-reported health related quality of life after two different operating techniques for low rectal cancer operated by rectal amputation, using a specific and detailed questionnaire. The population has been operated over a 6 year period in one university hospital.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

75

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Gothenburg, Sverige, SE 416 85
        • Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

colorectal section of one university hospital

Beskrivelse

Inclusion Criteria:

  • rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria:

  • no informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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 navne:
  • Abdomino perineal resection
  • Extra levator excision
  • Perineal excision
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 navne:
  • Abdomino perineal resection
  • Extra levator excision
  • Perineal excision

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Impact of rectal cancer surgery on household finances in a long-term perspective
Tidsramme: 2-7 years after operation
Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.
2-7 years after operation
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
2-7 years after operation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Eva Angenete, MD,PhD, Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

24. marts 2011

Først indsendt, der opfyldte QC-kriterier

24. marts 2011

Først opslået (Skøn)

25. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2015

Sidst verificeret

1. september 2015

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner