Clinical trial NCT01323166: Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques
Official title: Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: rectal cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Foundation
First posted: 2011-03-25
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colorectal section of one university hospital

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.

Eligibility criteria: Inclusion Criteria:

* rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
timeFrame: 2-7 years after operation
Secondary outcomes:
measure: Impact of rectal cancer surgery on household finances in a long-term perspective
timeFrame: 2-7 years after operation
measure: Impact of rectal cancer surgery and the level of intrusive thoughts
timeFrame: 2-7 years after operation
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
affiliation: Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
name: Eva Angenete, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Angenete E, Asplund D, Andersson J, Haglind E. Self reported experience of sexual function and quality after abdominoperineal excision in a prospective cohort. Int J Surg. 2014 Nov;12(11):1221-7. doi: 10.1016/j.ijsu.2014.10.003. Epub 2014 Oct 12.