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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Gothenburg, Suède, SE 416 85
- Dept. of Surgery, Sahlgrenska University Hospital/Ostra
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- rectal cancer operated by abdominoperineal resection 2004-2009
Exclusion Criteria:
- no informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
Autres noms:
|
|
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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Impact of rectal cancer surgery on household finances in a long-term perspective
Délai: 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
Délai: 2-7 years after operation
|
Part of the questionnaire analyses occurrence and effects of intsrusice thoughts
|
2-7 years after operation
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Eva Angenete, MD,PhD, Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- QoL after APR at SU
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .