Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle
2026年5月21日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Guangdong
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Guangzhou、Guangdong、中国
- Guangzhou University of Chinese Medicine
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：Fu's Acupuncture group
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The first postoperative exhaust and defecation time
時間枠：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
|
|
Recovery time of bowel sounds
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gastrointestinal Symptom Rating Scale, GSRS
時間枠：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
時間枠：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
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hour 6/hour 12/hour 36
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月27日
一次修了 (推定)
2027年3月27日
研究の完了 (推定)
2027年3月27日
試験登録日
最初に提出
2026年4月29日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月26日
QC基準を満たした最後の更新が送信されました
2026年5月21日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- YF2026-112-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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