Clinical trial NCT01296984: Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal Cancer
Official title: A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal cancer
APR
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Foundation
First posted: 2011-02-16
Enrollment: 1319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All swedish patients registerd in the swedish rectalcancer registry undergoing APR 2007-2009

Brief summary: The aim of the project is to evaluate the oncological and functional outcome of the more extensive perineal dissection - i.e the extra levator resection - in abdominoperineal resections in patients with rectal cancer.

Hypothesis: Extra levator perineal resection reduces local recurrence three year postoperatively compared to traditional abdominoperineal resection and improves QoL 2-4 years postoperatively.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer operated with APR 2007-2009

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: 3-year local recurrence
timeFrame: 3 years postoperatively
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days
measure: Reoperation, readmittance and mortality
timeFrame: 12 months
measure: Late morbidity
timeFrame: 24-48 months postoperatively
measure: Quality of Life
timeFrame: 24-48 months postoperatively
measure: Health economy
timeFrame: 24-48 months postoperatively
measure: Stoma function
timeFrame: 24-36 months postop
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: SSORG, Sahlgrenska Universitetssjukhuset, Område 2
state: Västra Götalandsregionen
Study officials:
References:
citation: Gonzalez E, Holm K, Wennstrom B, Haglind E, Angenete E. Self-reported wellbeing and body image after abdominoperineal excision for rectal cancer. Int J Colorectal Dis. 2016 Oct;31(10):1711-7. doi: 10.1007/s00384-016-2628-0. Epub 2016 Aug 10.
citation: Asplund D, Prytz M, Bock D, Haglind E, Angenete E. Persistent perineal morbidity is common following abdominoperineal excision for rectal cancer. Int J Colorectal Dis. 2015 Nov;30(11):1563-70. doi: 10.1007/s00384-015-2328-1. Epub 2015 Aug 6.
citation: Prytz M, Angenete E, Haglind E. Abdominoperineal extralevator resection. Dan Med J. 2012 Sep;59(9):A4366.