Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal Cancer (APER)
A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Västra Götalandsregionen
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Gothenburg、Västra Götalandsregionen、瑞典、416 85
- SSORG, Sahlgrenska Universitetssjukhuset, Område 2
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Rectal cancer operated with APR 2007-2009
Exclusion Criteria:
- No informed consent
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Extralevator APR
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.
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Traditional APR
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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3-year local recurrence
大体时间：3 years postoperatively
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Local recurrence of rectal cancer 3 years after APR
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3 years postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative complications
大体时间：30 days
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postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis
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30 days
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Reoperation, readmittance and mortality
大体时间：12 months
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Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery
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12 months
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Late morbidity
大体时间：24-48 months postoperatively
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Late morbidity and functional disorders: prolonged wound healing, late infections, limping, pain, sitting problems, urinary incontinence, erectile dysfunction, stoma related dysfunction
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24-48 months postoperatively
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Quality of Life
大体时间：24-48 months postoperatively
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Patient experienced health and QoL 24-48 months postoperatively
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24-48 months postoperatively
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Health economy
大体时间：24-48 months postoperatively
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Health economy analysis of resource consumption
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24-48 months postoperatively
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Stoma function
大体时间：24-36 months postop
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Assessment of stoma function related both to construction and surgical technique and patient position
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24-36 months postop
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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- Prytz M, Angenete E, Haglind E. Abdominoperineal extralevator resection. Dan Med J. 2012 Sep;59(9):A4366.
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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