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- Sperimentazione clinica NCT06549829
l'effetto della preabilitazione ottimizzata per la nutrizione sull'intervento perioperatorio nel carcinoma epatocellulare primario
Impatto della preabilitazione ottimizzata per la nutrizione sugli esiti perioperatori nel carcinoma epatocellulare primario: uno studio randomizzato e controllato
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Jiangxi
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Shangrao, Jiangxi, Cina, 334000
- ShangRao People's Hospital
-
-
Zhejiang
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Hangzhou, Zhejiang, Cina, 310009
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Huzhou, Zhejiang, Cina, 313000
- Huzhou Central Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
-
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.
-
Exclusion Criteria:
-
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Altro: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in serum prealbumin concentration from baseline to postoperative day 1
Lasso di tempo: From baseline to postoperative day 1
|
peripheral blood |
From baseline to postoperative day 1
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
6-minute walk distance (meters)
Lasso di tempo: One week after surgery
|
walk test for six minutes(6MWT) |
One week after surgery
|
|
Postoperative serum prealbumin Concentration
Lasso di tempo: One day after surgery
|
peripheral blood |
One day after surgery
|
|
Postoperative Serum Albumin Concentration
Lasso di tempo: One day after surgery
|
peripheral blood |
One day after surgery
|
|
Postoperative Serum Retinol-Binding Protein Concentration
Lasso di tempo: One day after surgery
|
peripheral blood |
One day after surgery
|
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Yuan Ding, Second Affiliated Hospital, Zhejiang University, School of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2024-0344
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