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


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Not Enrolling
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Rectal Cancer

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Trial Information

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


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.


Inclusion Criteria:



- rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria:

- no informed consent

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure

Outcome Description:

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

Outcome Time Frame:

2-7 years after operation

Safety Issue:

Yes

Principal Investigator

Eva Angenete, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra

Authority:

Sweden: Regional Ethical Review Board

Study ID:

QoL after APR at SU

NCT ID:

NCT01323166

Start Date:

March 2011

Completion Date:

October 2011

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • Rectal Neoplasms

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