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Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle

21. mai 2026 oppdatert av: Zhenyu Zhang
A randomized controlled trial was conducted to compare the clinical efficacy of Fu's subcutaneous acupuncture and western medication in the treatment of gastrointestinal dysfunction after knee surgery under general anesthesia. The difference in clinical efficacy between the Fu's subcutaneous acupuncture group and the western medication group was analyzed, and the mechanism of Fu's subcutaneous acupuncture in the treatment of gastrointestinal dysfunction after general anesthesia was further explored. It was confirmed that Fu's subcutaneous acupuncture can effectively promote postoperative gastrointestinal motility and reduce postoperative gastrointestinal discomfort. It can shorten the recovery time of gastrointestinal function, improve the quality of life of patients during the perioperative period, and explore the improvement of postoperative complications and promote the postoperative rehabilitation of patients, which is worthy of clinical application.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Postoperative gastrointestinal dysfunction refers to the symptoms such as abdominal distension, nausea and vomiting, constipation, and weakened or disappeared bowel sounds caused by preoperative anesthesia, postoperative fasting, use of analgesics, prolonged bed rest, and early drinking after surgery. It is a common complication of surgery. The use of opioid analgesics during and after general anesthesia can bind to the opioid receptors distributed in the presynaptic neurons of the intestinal muscle layer, resulting in the decrease of intestinal peristalsis waves and the cessation of motility, leading to the occurrence of postoperative gastrointestinal dysfunction, with an incidence of up to 81%. The delayed recovery of gastrointestinal function after surgery can lead to intestinal obstruction or paralysis, anastomotic leakage and other complications. It not only has adverse effects on the recovery process and quality of life, but also may increase the consumption of medical resources. Studies have shown that the incidence of Postoperative gastrointestinal dysfunction in abdominal surgery can be as high as 10% to 30%. In recent years, the incidence of Postoperative gastrointestinal dysfunction has not decreased significantly, but has increased by 10% in Japan. Patients with Postoperative gastrointestinal dysfunction have a longer hospital stay than those without POGD, and have more postoperative complications such as infection and postoperative intestinal obstruction, which brings a greater economic burden to patients and society. At present, a simple, convenient and effective method to restore gastrointestinal function is the key to reduce postoperative complications and rapid recovery to reduce the length of hospital stay, and it is also the key problem to be solved during the perioperative period.

Studietype

Intervensjonell

Registrering (Antatt)

72

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Guangzhou University of Chinese Medicine

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:

  1. Met the diagnostic criteria for postoperative gastrointestinal dysfunction as defined in the Clinical Practice Guidelines for the Prevention and Treatment of Postoperative Gastrointestinal Dysfunction Using Integrated Traditional Chinese and Western Medicine;
  2. Underwent elective knee surgery under general anesthesia;
  3. Had normal bowel habits prior to hospital admission;
  4. Were aged 18-80 years;
  5. Had no severe systemic comorbidities or organic gastrointestinal disorders;
  6. Provided written informed consent after receiving comprehensive information regarding the study's objectives, procedures, potential benefits, and associated risks.

All patients in both groups received standard postoperative symptomatic management, including routine wound dressing changes and patient-controlled analgesia.

Exclusion Criteria:

  1. Patients with chronic diarrhea or constipation attributable to organic etiologies; those with confirmed organic lesions of the large intestine (e.g., inflammatory bowel disease, diverticulosis, or neoplasms); individuals diagnosed with malignant tumors; patients who developed postoperative complications including intra-abdominal infection, abdominal hemorrhage, or cerebrovascular events requiring transfer to the intensive care unit;
  2. Patients with severe cardiac, hepatic, or renal dysfunction (e.g., NYHA Class IV heart failure, Child-Pugh Class C cirrhosis, or estimated glomerular filtration rate <30 mL/min/1.73 m²);
  3. Patients with primary immunodeficiency disorders, active systemic infections, or uncontrolled autoimmune diseases;
  4. Patients with recent abdominal trauma, acute surgical abdomen, or documented hypersensitivity to any intervention-related medications or materials;
  5. Presence of active dermatological conditions-including macules, papules, erythema, urticaria, abrasions, lacerations, or ulcerations-at the intended site of Fu's subcutaneous needle insertion;
  6. Patients exhibiting severe needle phobia, persistent vertigo, or cognitive/psychological impairment that precludes reliable adherence to treatment protocols or informed consent procedures;
  7. Patients who initiated concomitant therapies (pharmacologic or non-pharmacologic) not stipulated in the study protocol after enrollment, thereby confounding efficacy assessment; and those with incomplete baseline or follow-up data essential for primary or secondary outcome evaluation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Conventional treatment group
Legemiddel: Mosapride
On the basis of routine postoperative care, the patients in the control group were treated with mosapride citrate tablets (Runan Beite Pharmaceutical Co., LTD., Chinese Medicine approved number H19990317, standard: 5mg), 5mg/ time, 3 times /d.
Eksperimentell: Fu's Acupuncture group
Enhet: Fu's Acupuncture group
The Fu's Acupuncture group received treatment 6 hours after the operation. One treatment session was conducted. The therapeutic effects were observed at 1 hour, 12 hours, and 36 hours after the treatment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The first postoperative exhaust and defecation time
Tidsramme: 6 hours/12 hours/36 hours/72 hours
  1. Exhaust time was recorded as the interval from the end of the operation to the first exhaust.
  2. Defecation time was recorded as the interval from the end of surgery to the first defecation.

The first postoperative exhaust and defecation time were recorded at 6 hours, 12 hours, 36 hours and 72 hours after operation
6 hours/12 hours/36 hours/72 hours
Recovery time of bowel sounds
Tidsramme: 6 hours /12 hours /36 hours /72 hours

Recovery time of bowel sounds: auscultation was performed 6 hours after the operation in both groups, and the bowel sounds were recorded 6 hours /12 hours /36 hours /72 hours after the operation. During abdominal auscultation, five key auscultation areas were selected: left lower abdomen, left upper abdomen, right upper abdomen, right lower abdomen and around the umbilicus (G letter shape). At least 3 minutes of auscultation per auscultation area, bowel sounds were assessed as being in the normal range only if they were heard in two or more areas at a frequency of (3-5) beats/min. The patients in the treatment group were treated with Fu's subcutaneous needling after operation, and the bowel sounds were recorded once after each treatment. Each auscultation was recorded by a special person.

Postoperative bowel sound recovery time: the time between the end of surgery and the time when bowel sounds returned to normal.
6 hours /12 hours /36 hours /72 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gastrointestinal Symptom Rating Scale, GSRS
Tidsramme: hour 6/hour 12/hour 36
According to the Chinese version of gastrointestinal symptom rating scale, GSRS included 15 items of abdominal pain, abdominal distension, nausea, vomiting, belching, acid reflux, satiety, loss of appetite, abdominal burning, abdominal discomfort, abnormal bowel sounds, difficult exhaust, incomplete defecation, dry stool and straining defecation. The severity and frequency of GSRS were evaluated. The sum of the scores of the two dimensions of all symptoms was the GSRS score, which ranged from 0 to 60, with higher scores indicating more severe symptoms. The GSRS scores were calculated immediately, 6h, 12h and 36h after treatment.
hour 6/hour 12/hour 36
Five-point Likert scale for abdominal distension
Tidsramme: hour 6/hour 12/hour 36
The degree of abdominal distension of the two groups was recorded before treatment, 6 h, 12 h and 36 h after treatment. The abdominal distension score was formulated according to the "Practical Integrated Traditional Chinese and Western Medicine Diagnosis and Therapy" and related literature using the 5-point Likert scale.For example, score 0: no abdominal distension or discomfort throughout the day; Score 1: occasional abdominal distention and discomfort throughout the day, but did not affect rest; score 2: persistent abdominal distention and discomfort for a long time throughout the day, affecting rest but could tolerate; Score 3: abdominal distension and discomfort for a long time throughout the day, affecting rest but can be tolerated; Score 4: persistent abdominal distention and discomfort throughout the day, affecting rest and requiring medication; 5 points: persistent severe abdominal distention and discomfort throughout the day, abdominal distention, percussion drum sounds
hour 6/hour 12/hour 36

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Zhenyu Zhang

Samarbeidspartnere

Guangzhou University of Chinese Medicine

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 (Faktiske)

27. mars 2026

Primær fullføring (Antatt)

27. mars 2027

Studiet fullført (Antatt)

27. mars 2027

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YF2026-112-01

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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