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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01323166
Acronym
APR
Enrollment
75
Registered
2011-03-25
Start date
2011-03-31
Completion date
2011-10-31
Last updated
2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal cancer

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREExcision of the levator muscle

Cylindrical perineal excision including the levator muscle

Sponsors

Swedish Cancer Foundation
CollaboratorOTHER
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion criteria

* no informed consent

Design outcomes

Primary

MeasureTime frameDescription
Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure2-7 years after operationA 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

Secondary

MeasureTime frameDescription
Impact of rectal cancer surgery on household finances in a long-term perspective2-7 years after operationPart of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.
Impact of rectal cancer surgery and the level of intrusive thoughts2-7 years after operationPart of the questionnaire analyses occurrence and effects of intsrusice thoughts

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026