- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07607249
Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국
- Guangzhou University of Chinese Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Conventional treatment group
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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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The first postoperative exhaust and defecation time
기간: 6 hours/12 hours/36 hours/72 hours
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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
기간: 6 hours /12 hours /36 hours /72 hours
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gastrointestinal Symptom Rating Scale, GSRS
기간: hour 6/hour 12/hour 36
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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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- YF2026-112-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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