Different Acupoint Stimulation for Postoperative Gastrointestinal Dysfunction in Primary Liver Cancer Patients
21. august 2026 oppdatert av: Shanghai Zhongshan Hospital
Application of Different Acupoint Stimulation Methods in the Prevention and Management of Postoperative Gastrointestinal Dysfunction in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Brief Summary (Plain Language) The purpose of this clinical trial is to evaluate and compare the effects of four different intervention measures on preventing and managing postoperative gastrointestinal dysfunction in patients with primary liver cancer. The four measures include herbal acupoint application, transcutaneous acupoint electrical stimulation, the combination of the above two acupoint stimulation methods, and routine clinical nursing. This study aims to provide scientific evidence for the clinical application of acupoint stimulation therapies in postoperative rehabilitation of liver cancer patients.
The main research question of this study is whether acupoint stimulation interventions can effectively improve postoperative gastrointestinal recovery in primary liver cancer patients. The primary outcome measure is the time to first postoperative anal exhaust, which is a core indicator to reflect the recovery of gastrointestinal function after surgery.
By comparing the differences in gastrointestinal recovery among the four groups, this trial will clarify the optimal acupoint intervention scheme to prevent and relieve postoperative gastrointestinal dysfunction in primary liver cancer patients, so as to improve patients' postoperative rehabilitation quality.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
132
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yan Zhu, Master of Nursing
- Telefonnummer: +86 18701869040
- E-post: zhu.yan4@zs-hospital.sh.cn
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients diagnosed with primary liver cancer scheduled for initial partial hepatectomy or laparoscopic partial hepatectomy.
- Aged between 18 and 75 years old.
- Clear consciousness and ability to communicate in writing.
- Voluntary participation with signed informed consent.
Exclusion Criteria:
- Patients receiving concurrent chemotherapy.
- Patients with adhesive plaster allergy or allergic constitution.
- Patients with local skin damage, infection or dermatitis at acupoint sites.
- Patients with cognitive dysfunction.
- Patients complicated with preoperative gastrointestinal dysfunction or with a history of gastrointestinal surgery.
- Patients undergoing associating liver partition and portal vein ligation for staged hepatectomy (ALPPS).
- Patients transferred to the intensive care unit (ICU) after surgery.
- Patients with implanted cardiac pacemakers.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Rutinemessig pleie
|
Patients receive standard postoperative routine nursing care only.
No additional acupoint-related interventions are provided throughout the study period.
|
|
Eksperimentell: Kombinert intervensjon
|
Initiated after stable vital signs on the surgery day.
Receive transcutaneous acupoint electrical stimulation first, then herbal acupoint application.
The specific operation standards are the same as the above two groups, performed once daily until the first anal exhaust.
|
|
Eksperimentell: Acupoint Application
|
Intervention starts after the patient returns to the ward with stable vital signs on the surgery day.
Herbal patches composed of Natrii Sulfas, Radix et Rhizoma Rhei, Fructus Aurantii Immaturus and Cortex Magnoliae Officinalis are applied to bilateral Zusanli (ST36), Shangjuxu (ST37) and Hegu (LI4).
Each application lasts 6 hours, once a day until the first anal exhaust.
Relevant observations are recorded during the process.
|
|
Eksperimentell: TAES
|
Treatment begins on the surgery day when vital signs stabilize after returning to the ward.
Electrodes are placed on bilateral Zusanli (ST36), Shangjuxu (ST37) and Hegu (LI4) for transcutaneous acupoint electrical stimulation with 2/100 Hz dense-disperse waves.
Current ranges from 1 mA up to patient's maximum tolerance (no more than 10 mA), 30 minutes per session once daily.
Treatment data is recorded accordingly.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to first postoperative flatus
Tidsramme: Perioperative, from the end of surgery until the first postoperative flatus occurs
|
Perioperative, from the end of surgery until the first postoperative flatus occurs
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to first defecation
Tidsramme: Perioperative
|
Perioperative
|
|
Incidence of postoperative gastrointestinal dysfunction
Tidsramme: Within 7 days after surgery
|
Within 7 days after surgery
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence and severity of postoperative intestinal obstruction
Tidsramme: Within 14 days after surgery
|
Within 14 days after surgery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Yan Zhu, Fudan University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Jiang T, Li J, Meng L, Wang J, Zhang H, Liu M. Effects of transcutaneous electrical acupoint stimulation on gastrointestinal dysfunction after gastrointestinal surgery: A meta-analysis. Complement Ther Med. 2023 May;73:102938. doi: 10.1016/j.ctim.2023.102938. Epub 2023 Feb 25.
- Wang MX. Effect of acupoint application during Chen period on gastrointestinal function recovery in patients with primary liver cancer after laparoscopic surgery[D]. Guangzhou University of Chinese Medicine, 2023.
- Shi XL, Li H, Bian LF, et al. Summary of best evidence for prevention and management of postoperative gastrointestinal dysfunction in patients with liver cancer. Journal of Enhanced Recovery After Surgery, 2024, 7 (4): 145-151.
- Li S, Liu KX, Deng XM, et al. Expert consensus on prevention and treatment of postoperative gastrointestinal dysfunction. International Journal of Anesthesiology and Resuscitation, 2021, 42 (11): 1133-1142.
- Expert Committee for the Guidelines for Diagnosis and Treatment of Primary Liver Cancer, Zhou J. Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition). Chinese Journal of Clinical Medicine, 2024, 31(2): 277-334.
- Cheng XN, Zhang X, Ji J, Zhou J. [Acupoints selection rules of acupuncture and moxibustion for promoting gastrointestinal function recovery after intestinal cancer surgery based on complex network analysis]. Zhen Ci Yan Jiu. 2024 Oct 25;49(10):1107-1120. doi: 10.13702/j.1000-0607.20230829. Chinese.
- Arfa S, Turco C, Lakkis Z, Bourgeois S, Fouet I, Evrard P, Sennegon E, Roucoux A, Paquette B, Devaux B, Rietsch-Koenig A, Heyd B, Doussot A. Delayed return of gastrointestinal function after hepatectomy in an ERAS program: incidence and risk factors. HPB (Oxford). 2022 Sep;24(9):1560-1568. doi: 10.1016/j.hpb.2022.03.014. Epub 2022 Apr 5.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
31. juli 2027
Studiet fullført (Antatt)
31. august 2027
Datoer for studieregistrering
Først innsendt
19. august 2026
Først innsendt som oppfylte QC-kriteriene
21. august 2026
Først lagt ut (Faktiske)
24. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B2026-222R
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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