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

Rectal Cancer Clinical Trial

— APR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323166
• Other study ID #: QoL after APR at SU
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: September 3, 2015
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: September 2015
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria:

• no informed consent

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• Excision of the levator muscle
Cylindrical perineal excision including the levator muscle

Locations

Country	Name	City	State
Sweden	Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Swedish Cancer Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure	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	Yes
Secondary	Impact of rectal cancer surgery on household finances in a long-term perspective	Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.	2-7 years after operation	No
Secondary	Impact of rectal cancer surgery and the level of intrusive thoughts	Part of the questionnaire analyses occurrence and effects of intsrusice thoughts	2-7 years after operation	Yes

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