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A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Rectal Cancer

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Trial Information

A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer


Low rectal cancer treated surgically by abdominoperineal resection (APR) has worse outcome
than other rectal cancers operated with low anterior resection. In order to improve the
outcome in the APR group a more extensive surgical procedure - the extra levator APR - has
been suggested. This study aims to investigate both the oncological and the functional
outcome of this method as compared to the traditional APR.

Method: All Swedish patients undergoing abdominoperineal resection for rectal cancer
2007-2009 will be analysed regarding operative technique (traditional or extra levator
resection). Data on all patients regarding pre op TNM classification, pathological report
and local recurrence will be collected from the Swedish Rectal Cancer registry. A validated
QoL form will be sent to each patient to further investigate the functional outcome, health
economy and Quality of Life 2-4 years postoperatively.

Data will be analysed regarding 3 year recurrence rate (primary endpoint) as well as
functional result and QoL (secondary endpoints) in the two different groups - i.e
traditional and extra levator APR.


Inclusion Criteria:



- Rectal cancer operated with APR 2007-2009

Exclusion Criteria:

- No informed consent

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

3-year local recurrence

Outcome Description:

Local recurrence of rectal cancer 3 years after APR

Outcome Time Frame:

3 years postoperatively

Safety Issue:

No

Authority:

Sweden: Regional Ethical Review Board

Study ID:

SSORG APER

NCT ID:

NCT01296984

Start Date:

February 2011

Completion Date:

January 2014

Related Keywords:

  • Rectal Cancer
  • Rectal cancer
  • APR
  • Rectal Neoplasms

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