- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07781176
Different Acupoint Stimulation for Postoperative Gastrointestinal Dysfunction in Primary Liver Cancer Patients
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yan Zhu, Master of Nursing
- 전화번호: +86 18701869040
- 이메일: zhu.yan4@zs-hospital.sh.cn
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 정기 관리
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Patients receive standard postoperative routine nursing care only.
No additional acupoint-related interventions are provided throughout the study period.
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실험적: 통합 개입
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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.
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실험적: Acupoint Application
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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.
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실험적: TAES
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Time to first postoperative flatus
기간: Perioperative, from the end of surgery until the first postoperative flatus occurs
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Perioperative, from the end of surgery until the first postoperative flatus occurs
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Time to first defecation
기간: Perioperative
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Perioperative
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Incidence of postoperative gastrointestinal dysfunction
기간: Within 7 days after surgery
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Within 7 days after surgery
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence and severity of postoperative intestinal obstruction
기간: Within 14 days after surgery
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Within 14 days after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yan Zhu, Fudan University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
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