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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Västra Götalandsregionen
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Gothenburg, Västra Götalandsregionen, 스웨덴, 416 85
- SSORG, Sahlgrenska Universitetssjukhuset, Område 2
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Rectal cancer operated with APR 2007-2009
Exclusion Criteria:
- No informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-year local recurrence
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative complications
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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