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Recruiting NCT06580197

The Role of AAT After Abdominal Surgery Based on RWS

Observational Acupuncture, Ear Gastroparesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auricular Acupoint Therapy.
Who it may be relevant to
Registry conditions: Acupuncture, Ear, Gastroparesis. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Application of Auricular Acupuncture Therapy Based on Real-World Studies After Abdominal Surgery

Overview

Delayed gastric emptying (DGE) after surgery mainly occurs after gastrointestinal surgery A functional gastric emptying disorder, clinically characterized by weak or absent gastric peristalsis, gastric motility disorders, or gastric emptying Gastric retention, fullness, nausea and other uncomfortable symptoms caused by delay.This study is based on clinical diagnosis and treatment practice, observing, collecting, and analyzing Whipple surgery, pancreatectomy, and gastric cancer Perioperative data of subtotal resection surgery, mainly observing the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatectomy, and subtotal gastrectomy.The application effect of DGE after resection surgery, exploring the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatic body and tail resection surgery, and Diagnostic value of perioperative related diseases in abdominal surgery such as subtotal gastrectomy, and collection of health records.By comparing and analyzing the ear acupoint information of patients with abdominal tumors, we aim to explore the ear acupoints of the volunteers. The possible relationship between image and resistance specificity and common tumors in the abdominal cavity.

Interventions

  • Other Auricular Acupoint Therapy
    Ear point diagnosis and treatment is one of acupuncture and moxibustion methods, which originates from the theory of acupuncture and moxibustion meridians and is the product of the combination of modern Chinese medicine and western medicine, including two parts: auricular acupoint diagnosis and auriculotherapy. Ear point diagnosis refers to the determination of auricle positive reaction points through vision, touch, pressure and other methods to diagnose diseases in some parts of the body on the

Primary outcome measures

  • Clinical total effective rate [Time frame: On the third day after surgery]
  • Perioperative Anxiety Scale-7 (PAS-7) [Time frame: 24±2h after the start of AP or first visit, 12±2h before surgery, and 2 h before surgery]
Secondary outcome measures (4)
  • Modified Pittsburgh Sleep Quality Index (M-PSQI) [Time frame: 24±2h after the start of AP or first visit (T1), 12±2h before surgery (T2), and 72±2h post-operatively]
  • Self-Rating Anxiety Scale (SAS) Score [Time frame: Multiple time points before and after surgery]
  • Patient Satisfaction with Pre-operative Preparation Assessed with the Visual Analogue Scale (VAS-Satisfaction) [Time frame: Preoperative]
  • Visual Analogue Scale for Pain (VAS-Pain) [Time frame: Multiple time points after surgery]

Eligibility criteria

Inclusion criteria

\- 1) Age range: 40-70 years old (40 ≤ y ≤ 70), gender is not limited. 2) Accept abdominal surgeries including Whipple's surgery, pancreatectomy, and subtotal gastrectomy.

3\) The subjects/guardians are able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form (ICF)

Exclusion criteria

  • 1\) Severe postoperative complications such as heart disease, pulmonary embolism, cerebral infarction, abdominal infection, and abdominal bleeding; 2) Patients with organic changes such as adhesions and obstructions indicated by imaging examinations such as gastrointestinal imaging; 3) The patient has damage, redness, bleeding, infection, and other conditions in both ears that are not suitable for ear acupuncture treatment.

Inclusion and exclusion criteria for the health group

Inclusion criteria

  • Age range: 40-70 years old (40 ≤ y ≤ 70), gender is not limited.
  • No history of abdominal surgery or tumor, and no significant abnormalities were found through abdominal imaging examination.
  • The subjects/guardians are able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form (ICF).

Exclusion criteria

  • Symptoms of digestive discomfort such as diarrhea, constipation, and vomiting have been present for the past 30 days.
  • The patient has conditions such as damage, redness, bleeding, and infection in both ears that affect the assessment of ear acupoint information.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking union medical college hospital — Beijing

Identifiers

NCT: NCT06580197 · K6357

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗