- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06549829
원발성 간세포암종의 수술 전후 중재에 대한 영양 최적화 사전 재활의 효과
영양 최적화된 재활이 원발성 간세포암종의 수술 전후 결과에 미치는 영향: 무작위 대조 시험
This study aimed to evaluate whether nutritional optimization-led triple prehabilitation could improve perioperative nutritional status, promote postoperative recovery, and reduce postoperative complications in patients with primary liver cancer undergoing surgery. After screening according to the inclusion and exclusion criteria, eligible patients were randomized into experimental and control groups. Both groups received exercise and psychological interventions; for nutritional intervention, the experimental group received an ordinary diet plus oral nutritional supplementation, whereas the control group received an ordinary diet alone. Routine clinical blood tests were performed at the time of enrollment and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.
연구 개요
상태
상세 설명
Study subgroups: experimental group (nutritional optimization-led triple prehabilitation), control group (conventional triple prehabilitation) , with a 1:2 allocation ratio between experimental and control groups.
Intervention measures The nutritional status of each participant will be assessed in collaboration with a clinical nutritionist to develop an individualized nutritional plan. The experimental group will receive oral nutritional supplementation (ONS; Ensure) in addition to their usual diet, whereas the control group will receive their usual diet alone.
Resting energy expenditure (REE) will be estimated using the revised Harris-Benedict equations:
Men: REE (kcal/day) = 88.362 + 13.397W + 4.799H - 5.677A Women: REE (kcal/day) = 447.593 + 9.247W + 3.098H - 4.330A where W is body weight (kg), H is height (cm), and A is age (years). The estimated daily energy requirement will be calculated as REE * 1.3 (activity factor) * 1.2 (stress factor). Assuming a usual dietary energy intake of approximately 1,600 kcal/day, the additional energy to be supplied by ONS will be calculated by subtracting 1,600 kcal from the estimated daily energy requirement. Ensure powder provides 4.50 kcal/g; therefore, the required daily amount of powder will be calculated by dividing the additional energy requirement by 4.50 kcal/g.
The calculated daily amount of Ensure powder will be divided into three doses, each dissolved in 200 mL of warm water and taken orally between meals. Adherence will be monitored by the nursing team and clinical nutritionist, who will record actual supplement intake. The intervention will begin at enrollment and continue until the day before surgery.
Other interventions:
A personalized exercise program will be developed with the rehabilitation physician, and both groups will undergo exercise to increase lung capacity and cardiorespiratory tolerance: respiratory exercise will be included - patients will be guided to learn to cough and cough up sputum with deep breaths before the operation, and a respiratory trainer will be used for bedside training.
Exercise planning: in addition to respiratory training, patients will perform aerobic exercise (jogging or walking) and resistance exercise (dumbbells or resistance bands), with intensity and frequency individualized according to baseline fitness.
The experimental and control groups will undergo psychiatric intervention: patients will be psychologically evaluated with the Hospital Anxiety and Depression Scale (HADS), together with the Fatigue Assessment Scale (FAS). Those with elevated anxiety or depression (HADS ≥ 11) will receive psychological counseling 3-5 times during the preoperative week and medication when necessary, and will be guided to listen to soothing music for at least 15 minutes before bedtime daily.
The patients will undergo routine clinical blood tests at the time of enrollment and the 1st, 3rd and 5th days after the operation.
Follow-up The patients will be followed up by telephone or outpatient clinic at 1 month after the operation; the patients' clinical data will be recorded.
The relevant clinical data during the process will be recorded.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Jiangxi
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Shangrao, Jiangxi, 중국, 334000
- ShangRao People's Hospital
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310009
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Huzhou, Zhejiang, 중국, 313000
- Huzhou Central Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Patients diagnosed with primary liver cancer.
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Patients between the ages of 18 and 80.
- Patients who are feasible for surgical treatment after clinical evaluation.
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Exclusion Criteria:
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Patients with liver metastases or combined with other tumors.
- Patients with allergy to the ingredients of nutritional preparations. ③Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.
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 |
|---|---|
|
실험적: Nutritional optimization-led triple prehabilitation Intervention
Nutritional optimization-led triple prehabilitation |
The nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan. The experimental group used ordinary dietary supplementation + oral nutritional supplementation, and the control group used ordinary dietary supplementation. The target energy was calculated as resting energy expenditure (REE, revised Harris-Benedict [Shizgal-Rosa] equation) × 1.3 (activity factor) × 1.2 (stress factor), and the oral nutritional supplement dose was (target energy - 1,600 kcal) ÷ 4.50 kcal/g. Exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance. Specialized psychological interventions. |
|
다른: Conventional triple prehabilitation Intervention
Conventional triple prehabilitation |
Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in serum prealbumin concentration from baseline to postoperative day 1
기간: From baseline to postoperative day 1
|
peripheral blood |
From baseline to postoperative day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6-minute walk distance (meters)
기간: One week after surgery
|
walk test for six minutes(6MWT) |
One week after surgery
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|
Postoperative serum prealbumin Concentration
기간: One day after surgery
|
peripheral blood |
One day after surgery
|
|
Postoperative Serum Albumin Concentration
기간: One day after surgery
|
peripheral blood |
One day after surgery
|
|
Postoperative Serum Retinol-Binding Protein Concentration
기간: One day after surgery
|
peripheral blood |
One day after surgery
|
공동 작업자 및 조사자
수사관
- 연구 의자: Yuan Ding, Second Affiliated Hospital, Zhejiang University, School of Medicine
간행물 및 유용한 링크
일반 간행물
- Noba L, Rodgers S, Chandler C, Balfour A, Hariharan D, Yip VS. Enhanced Recovery After Surgery (ERAS) Reduces Hospital Costs and Improve Clinical Outcomes in Liver Surgery: a Systematic Review and Meta-Analysis. J Gastrointest Surg. 2020 Apr;24(4):918-932. doi: 10.1007/s11605-019-04499-0. Epub 2020 Jan 3.
- Lin Y, Zheng L, Fang K, Zheng Y, Wu J, Zheng M. Proportion of liver cancer cases and deaths attributable to potentially modifiable risk factors in China. Int J Epidemiol. 2023 Dec 25;52(6):1805-1814. doi: 10.1093/ije/dyad100.
- Zhou YM, Zhang XF, Li B, Sui CJ, Yang JM. Postoperative complications affect early recurrence of hepatocellular carcinoma after curative resection. BMC Cancer. 2015 Oct 14;15:689. doi: 10.1186/s12885-015-1720-0.
- Forsmo HM, Pfeffer F, Rasdal A, Sintonen H, Korner H, Erichsen C. Pre- and postoperative stoma education and guidance within an enhanced recovery after surgery (ERAS) programme reduces length of hospital stay in colorectal surgery. Int J Surg. 2016 Dec;36(Pt A):121-126. doi: 10.1016/j.ijsu.2016.10.031. Epub 2016 Oct 22.
- Davis JF, van Rooijen SJ, Grimmett C, West MA, Campbell AM, Awasthi R, Slooter GD, Grocott MP, Carli F, Jack S. From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. Curr Anesthesiol Rep. 2022;12(1):129-137. doi: 10.1007/s40140-022-00516-2. Epub 2022 Feb 18.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
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