- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02084524
ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery. (ANC1)
Malnutrition priori a major abdominal surgery is frequent and increases morbidity and mortality. The management of malnutrition has an impact in reducing postoperative complications. However malnutrition is rarely detected and Guidelines infrequently followed.
Recovery time and nutritional evaluation in elderly patients are major criteria in their postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its treatment. It is therefore unsurprising that many validated tools for nutrition risk screening and nutrition assessment exist for the clinician to use in assisting with the accurate identification, referral and treatment of patients who are malnourished or at risk of malnutrition.
And nutritional management must be adapted and based on this evaluation and evolution of the general status (Guidelines Grade A).
A geriatric evaluation based on a screening of preoperative malnutrition should allow a better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN) guidelines.
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pierre Benite, 프랑스, 69495
- 모병
- Professeur Marc BONNEFOY
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연락하다:
- Laurent VILLENEUVE
- 전화번호: 04 788 645 36
- 이메일: laurent.villeneuve@chu-lyon.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged ≥ 70 years
- Colorectal or tumor resection with/without synchronous metastases
Exclusion Criteria:
- Emergency resection of colorectal tumor
- Unresectable colorectal tumor with/without synchronous metastases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Nutritional evaluation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perioperative nutritional management
기간: During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days
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Rate of nutritional support implemented in accordance with current European guidelines (ESPEN)
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During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Malnutrition screening
기간: During preoperative seven days
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Rate of malnutrition screening procedure
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During preoperative seven days
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Rate of preoperative nutritional management by immunonutrition implemented
기간: During preoperative seven days
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Nutritional management by immunonutrition implemented is based on a complete nutritional evaluation
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During preoperative seven days
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Rate of malnourished patients
기간: During preoperative seven days
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Rate of malnourished patients is defined by the ESPEN criteria
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During preoperative seven days
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Rate of patients with cachexia
기간: Seventh day preoperative
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Rate of patients with cachexia is defined by the French National Authority for Health (HAS) criteria
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Seventh day preoperative
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Postoperative complications
기간: Postoperative follow-up until discharge from hospital, up to 30 days
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Rate and type of postoperative complications (Grade I, II et IIIa of Dindo classification)
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Postoperative follow-up until discharge from hospital, up to 30 days
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Rate of postoperative nutritional management implemented
기간: Postoperative follow-up until discharge from hospital, up to 30 days
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Nutritional management implemented is based on the ESPEN guidelines
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Postoperative follow-up until discharge from hospital, up to 30 days
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Evolution of the activities of daily living
기간: During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days
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Variations of Activities of daily living (ADL) and Instrumental activities of daily living (IADL) scores
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During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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. .