- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03070626
Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance due to surgical stress.
The aim of this study is to investigate whether preoperative oral carbohydrate loading can contribute to lower incidence of postoperative discomfort and to reduce complications in elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).
연구 개요
상세 설명
Fasting from 6-12hours before elective surgery is still standard of care in many departements, including our departement in Oslo University Hospital.
Surgery is a trauma that triggers a catabolic stress response with high emissions of hormones and immune activation. These activations can affect brain, heart, muscles and liver. The metabolic changes may in addition influence development of pain, tissue damage, ileus, tachycardia and other hemodynamic disturbances. Preoperative fasting has shown an increase of surgical stress and to impact catabolic processes which secondarily may lead to insulin resistance and hyperglycemia in non-diabetic patients. Insulin resistance and hyperglycaemia are known to increase the incidence of postoperative infections. Previous studies have also shown that prolonged fasting increases the incidence of gastrointestinal problems. A 12 hour fast before surgery has shown delayed recovery.
Studies have shown that patients undergoing lung cancer surgery suffer from multiple symptoms and experience discomfort in the postoperative phase. Symptoms include dyspnea, fatigue, pain, weakness, cough, dry mouth, nervousness, difficulty sleeping, stomach-/intestinal-problems and lack of appetite. Carbohydrate-rich supplements have shown a positive effect on other perioperative symptoms and measures, but is to our knowledge currently not investigated in lung cancer surgery.
Therefore, there is a need to explore the possible advantages of preoperative oral carbohydrate loading in lung cancer surgery.
The primary aim of this study is to investigate whether preoperative carbohydrate loading with PreOp® provides less postoperative discomfort in the early postoperative phase measured by Quality of Recovery-40 (QoR-40), a validated and widely used measure of quality of recovery.
The secondary aim is to investigate if preoperative loading with carbohydrates affect the incidence of postoperative complications such as stomach-/intestinal problems and heart rhythm disorder, in addition to contribute to faster mobilization and to reduce hospital length of stay.
This study may provide important data regarding the lung cancer patients perioperative symptoms, complications and well-being when using a carbohydrate-rich supplement as intervention to standard of care.
In this study, the intervention group will be given 800ml of a oral carbohydrate supplement, PreOp®, the night before surgery and 400ml of the same supplement, PreOp®, 2-4 hours prior to surgery. The control group will be fasted from 24h, the night before surgery, in accordance to the departements standard of care.
Both groups, the interventional and the control group, will follow the department's perioperative course with regard to anesthetic and surgical procedures.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oslo, 노르웨이, 0450
- 모병
- Oslo University Hospital
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연락하다:
- Per Reidar Woldbaek, MD, PhD
- 전화번호: +4798895427
- 이메일: uxpewo@ous-hf.no
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연락하다:
- Astrid Krohn-Hansen, RN
- 전화번호: +4792270669
- 이메일: astkro@ous-hf.no
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
adult patients undergoing elective video-assisted thoracoscopic surgery due to lung neoplasms.
- ability to understand and speak Norwegian
Exclusion Criteria:
- impaired gastric emptying
- diabetes
- ongoing treatment for pain
- ongoing infection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Interventional group
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
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No preoperative drink.
다른 이름들:
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간섭 없음: Control group
Standard of care: Fasting from 24hours (midnight), night before surgery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
기간: First postoperative day
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Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
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First postoperative day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gastrointestinal discomfort postoperatively.
기간: First seven postoperative days.
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Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.
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First seven postoperative days.
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Heart rhythm disturbances postoperatively.
기간: First seven postoperative days.
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Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.
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First seven postoperative days.
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Time to mobilization.
기간: First seven postoperative days.
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Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.
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First seven postoperative days.
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Length of stay
기간: First seven postoperative days.
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Length of hospital stay to discharge for index admission.
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First seven postoperative days.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
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PreOp®에 대한 임상 시험
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University of NottinghamEnhanced Recovery After Surgery Group (part of ESPEN)완전한
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Pomeranian Medical University Szczecin알려지지 않은