Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal Cancer (APER)
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|ClinicalTrials.gov Identifier: NCT01296984|
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : November 19, 2014
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||1319 participants|
|Observational Model:||Case Control|
|Official Title:||A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer|
|Study Start Date :||February 2011|
|Primary Completion Date :||March 2014|
|Study Completion Date :||June 2014|
The perineal part of the APR is done with the intent to create a cylindrically shaped specimen thus removing part of or the entire levator muscle with the specimen.
The perineal part of the APR is performed with the intent to remove the tumour with CRM free of tumour and the levator left in place.
- 3-year local recurrence [ Time Frame: 3 years postoperatively ]Local recurrence of rectal cancer 3 years after APR
- Postoperative complications [ Time Frame: 30 days ]postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis
- Reoperation, readmittance and mortality [ Time Frame: 12 months ]Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery
- Late morbidity [ Time Frame: 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
- Quality of Life [ Time Frame: 24-48 months postoperatively ]Patient experienced health and QoL 24-48 months postoperatively
- Health economy [ Time Frame: 24-48 months postoperatively ]Health economy analysis of resource consumption
- Stoma function [ Time Frame: 24-36 months postop ]Assessment of stoma function related both to construction and surgical technique and patient position
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296984
|SSORG, Sahlgrenska Universitetssjukhuset, Område 2|
|Gothenburg, Västra Götalandsregionen, Sweden, 416 85|