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effekten af ​​ernæringsoptimeret præhabilitering på perioperativ intervention i primært hepatocellulært karcinom

Ernæringsoptimeret præhabiliterings indvirkning på perioperative resultater i primært hepatocellulært karcinom: et randomiseret kontrolleret forsøg

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

132

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Jiangxi
      • Shangrao, Jiangxi, Kina, 334000
        • ShangRao People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310009
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Huzhou, Zhejiang, Kina, 313000
        • Huzhou Central Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with primary liver cancer.

    • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in serum prealbumin concentration from baseline to postoperative day 1
Tidsramme: From baseline to postoperative day 1

peripheral blood

From baseline to postoperative day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6-minute walk distance (meters)
Tidsramme: One week after surgery

walk test for six minutes(6MWT)

One week after surgery
Postoperative serum prealbumin Concentration
Tidsramme: One day after surgery

peripheral blood

One day after surgery
Postoperative Serum Albumin Concentration
Tidsramme: One day after surgery

peripheral blood

One day after surgery
Postoperative Serum Retinol-Binding Protein Concentration
Tidsramme: One day after surgery

peripheral blood

One day after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Yuan Ding, Second Affiliated Hospital, Zhejiang University, School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. maj 2024

Primær færdiggørelse (Faktiske)

1. september 2026

Studieafslutning (Faktiske)

29. september 2026

Datoer for studieregistrering

Først indsendt

13. maj 2024

Først indsendt, der opfyldte QC-kriterier

8. august 2024

Først opslået (Faktiske)

12. august 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2026

Sidst verificeret

1. oktober 2026

Mere information

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