- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01323166
Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques (APR)
Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life
연구 개요
상세 설명
Low rectal cancer treated by abdominoperineal resection (APR, rectal amputation)has worse prognosis than other rectal cancers, both regarding local recurrence and cancer specific survival. With a view to improve local recurrence rates a more extensive perineal operation (excision of the levator muscle) has been suggested. In our university hospital thie technique was introduced for all surgeons January 2007. A population of all patients operated from 1 January 2007 to 31 December 2009 was compared to all patients operated from 1 January 2004 to 31 December 2006 using the traditional, less extensive method, in all a six year period and 158 patients.
A specific questionnaire was developed after in depth interviews, and was face-validated by patients who had undergone an APR. This questionnaire will be sent out to all patients in our population who are still alive.
The patients will be contacted first by a letter of invitation, later called by telephone to be given more information and asked for permission to send the questionnaire.
The send out of invitation letters will start March 2011.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Gothenburg, 스웨덴, SE 416 85
- Dept. of Surgery, Sahlgrenska University Hospital/Ostra
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- rectal cancer operated by abdominoperineal resection 2004-2009
Exclusion Criteria:
- no informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Excision of the levator muscle
The abdominal part of the operation is performed as an TME and the perineal part of the operation is performed with the intent to get a cylindrical specimen thus removing part of or the entire levator muscle with the specimen
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Cylindrical perineal excision including the levator muscle
다른 이름들:
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Traditional perineal operation
The abdominal part of the operation performed as a TME.
The perineal operation performed with the intent of removing the tumour with CRM free of tumour and the levator left in place
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Cylindrical perineal excision including the levator muscle
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
기간: 2-7 years after operation
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A detailed questionnaire with 250 questions, where emphasis is on physical satisfaction and emotional status as well as bowel function, sexual function and stoma function 2-7 years after rectal amputation
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2-7 years after operation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Impact of rectal cancer surgery on household finances in a long-term perspective
기간: 2-7 years after operation
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Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.
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2-7 years after operation
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Impact of rectal cancer surgery and the level of intrusive thoughts
기간: 2-7 years after operation
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Part of the questionnaire analyses occurrence and effects of intsrusice thoughts
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2-7 years after operation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Eva Angenete, MD,PhD, Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
간행물 및 유용한 링크
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .