Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-30 @ 3:50 AM
Study NCT ID:
NCT01323166
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2011-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques
Sponsor:
Sahlgrenska University Hospital
Organization:
Study Overview
Official Title:
Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APR
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: