Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases (HQOL)
Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases A Prospective Multicenter Study
연구 개요
상세 설명
Background: Hepatic resection is the only treatment with potential curative intent for patients having colorectal liver metastases. Combined with chemotherapy, the overall 5-year survival is 40-50%. The disease free 5-year survival is about 20%, and about 70% of resected patients experience recurrence from their disease. Even if surgery is superior all other treatments, most patients will finally die from their cancer. However; surgery contributes by adding years of life, and for a minority, a disease free life. There has been much effort to study predictors for outcome after surgery, but little has been focused on quality of life following this treatment.
Method: EORTC Validated questionnaire (European Organisation Research of Treatment of Cancer) version QLQ-C30 (3.0) and QLQ LMC21. The patients fill out the questionnaire before surgery as a baseline, and then after 3,6 and 12 months after surgery. The investigators also register important clinicopathological data about each patient prospectively.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Bergen, 노르웨이, N-5020
- 모병
- Departement of acute and digestive surgery, surgical clinic, Haukeland University Hospital
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연락하다:
- Arild Horn, MD, PhD
- 전화번호: +4755972797
- 이메일: arild.horn@helse-bergen.no
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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:
- Liver metastasis from colorectal cancer
- Resectability, with intension of R0 resection
- No macroscopic tumor left after surgery
- Patients with combined resectable extrahepatic tumors are also included.
- Patients must complete the questionnaire before the operation.
Exclusion Criteria:
- Drop out of questionnaire after surgery
- Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Health related quality of life after liver resection in combination with chemotherapy
기간: 12 months after surgery
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The EORTC board has made validated questionaries with manuals for measuring quality of life.
The important focus is to see if and when patients gain their HQoL as they did have before surgery.
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12 months after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Identifying possible clinical parameters influencing the HQoL after liver resection.
기간: Up to one year after surgery, maybe longer
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Examples of parameters: complications, extent of surgery, chemotherapy.
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Up to one year after surgery, maybe longer
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공동 작업자 및 조사자
수사관
- 연구 책임자: August Bakke, Professor, Director, Surgical clinic, Haukeland University Hospital, Helse-Bergen HF, N-5020 Bergen, Norway
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .