Rectal Cancer
Conditions
Keywords
Rectal cancer, APR
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.
Interventions
None listed
Sponsors
Swedish Cancer Foundation
Sahlgrenska University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rectal cancer operated with APR 2007-2009
Exclusion criteria
* No informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year local recurrence | 3 years postoperatively | Local recurrence of rectal cancer 3 years after APR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation, readmittance and mortality | 12 months | Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery |
| Late morbidity | 24-48 months postoperatively | Late morbidity and functional disorders: prolonged wound healing, late infections, limping, pain, sitting problems, urinary incontinence, erectile dysfunction, stoma related dysfunction |
| Postoperative complications | 30 days | postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis |
| Health economy | 24-48 months postoperatively | Health economy analysis of resource consumption |
| Stoma function | 24-36 months postop | Assessment of stoma function related both to construction and surgical technique and patient position |
| Quality of Life | 24-48 months postoperatively | Patient experienced health and QoL 24-48 months postoperatively |
Countries
Sweden
Outcome results
None listed