Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle
21 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
72
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Guangdong
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Guangzhou, Guangdong, Chine
- Guangzhou University of Chinese Medicine
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- 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;
- Underwent elective knee surgery under general anesthesia;
- Had normal bowel habits prior to hospital admission;
- Were aged 18-80 years;
- Had no severe systemic comorbidities or organic gastrointestinal disorders;
- 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:
- 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;
- 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);
- Patients with primary immunodeficiency disorders, active systemic infections, or uncontrolled autoimmune diseases;
- Patients with recent abdominal trauma, acute surgical abdomen, or documented hypersensitivity to any intervention-related medications or materials;
- Presence of active dermatological conditions-including macules, papules, erythema, urticaria, abrasions, lacerations, or ulcerations-at the intended site of Fu's subcutaneous needle insertion;
- Patients exhibiting severe needle phobia, persistent vertigo, or cognitive/psychological impairment that precludes reliable adherence to treatment protocols or informed consent procedures;
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Conventional treatment group
|
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.
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Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The first postoperative exhaust and defecation time
Délai: 6 hours/12 hours/36 hours/72 hours
|
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
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Recovery time of bowel sounds
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gastrointestinal Symptom Rating Scale, GSRS
Délai: 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.
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hour 6/hour 12/hour 36
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Five-point Likert scale for abdominal distension
Délai: hour 6/hour 12/hour 36
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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
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hour 6/hour 12/hour 36
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Collaborateurs et enquêteurs
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Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 mars 2026
Achèvement primaire (Estimé)
27 mars 2027
Achèvement de l'étude (Estimé)
27 mars 2027
Dates d'inscription aux études
Première soumission
29 avril 2026
Première soumission répondant aux critères de contrôle qualité
21 mai 2026
Première publication (Réel)
26 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- YF2026-112-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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