The Role of AAT After Abdominal Surgery Based on RWS

NCT06580197 | Recruiting DMC

• 1 other identifier: K6357
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acupuncture, Ear; Gastroparesis

Outcome Measures

Primary Outcomes (2)

• Clinical total effective rate

  The clinical total effective rate of ear acupuncture treatment for postoperative DGE in the abdomen, including Whipple surgery, pancreatectomy, and subtotal gastrectomy. Efficacy evaluation criteria: Measure the subjective symptom score (Gastroparesis Cardinal Symptom Index, GCSI score) of patients with gastroparesis on the third day after surgery, and calculate the clinical efficacy index of ear acupuncture treatment using the following formula (efficacy index=\[(total score of symptoms before treatment - total score of symptoms after treatment) ÷ total score of symptoms before treatment × 100%\]). Among them, significant effect: efficacy index\>75%; Effective: Efficacy index of 25% to 75%; Invalid: Efficacy index\<25%. Total effective rate=(number of significantly effective cases+number of effective cases)/total number of cases x 100%.

  On the third day after surgery

• Perioperative Anxiety Scale-7 (PAS-7)

  This scale was used to evaluate the anxiety of patients before surgery. This scale evaluates some of the patient's conditions regarding the operation, and then, based on the actual situation during the days of hospitalization, selects the appropriate option among 5 options, circling the corresponding numbers. The higher the score, the more severe the patient's preoperative anxiety level.

  24±2h after the start of AP or first visit, 12±2h before surgery, and 2 h before surgery

Secondary Outcomes (4)

• Modified Pittsburgh Sleep Quality Index (M-PSQI)

  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

  Multiple time points before and after surgery

• Patient Satisfaction with Pre-operative Preparation Assessed with the Visual Analogue Scale (VAS-Satisfaction)

  Preoperative

• Visual Analogue Scale for Pain (VAS-Pain)

  Multiple time points after surgery

Study Arms (3)

Surgical control group (Group A)

Patients who received ear acupuncture treatment (≥ 1 time) due to perioperative anxiety, pain, prevention/treatment of DGF, or other indications for ear acupuncture treatment in actual diagnosis and treatment were divided into two groups based on exposure factors. Patients who received ear acupuncture treatment were included in the surgical observation group (Group B), while other patients were included in the surgical control group (Group A). Both groups of patients were from the basic surgical ward of Peking Union Medical College Hospital and were planning to undergo abdominal surgeries such as Whipple, pancreaticoidectomy, and subtotal gastrectomy;

Surgical observation group (Group B)

Patients who received ear acupuncture treatment (≥ 1 time) due to perioperative anxiety, pain, prevention/treatment of DGF, or other indications for ear acupuncture treatment in actual diagnosis and treatment were divided into two groups based on exposure factors. Patients who received ear acupuncture treatment were included in the surgical observation group (Group B), while other patients were included in the surgical control group (Group A). Both groups of patients were from the basic surgical ward of Peking Union Medical College Hospital and were planning to undergo abdominal surgeries such as Whipple, pancreaticoidectomy, and subtotal gastrectomy;

Other: Auricular Acupoint Therapy

Healthy control group (Group C)

According to the surgical observation group (Group B), the healthy control group (Group C) consisted of healthy volunteers from the same period at the Beijing Union Medical College Hospital Health Examination Center.

Interventions

Auricular Acupoint Therapy OTHER

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 basis of ear point theory. Ear point treatment refers to the use of certain therapeutic devices on ear points to achieve the purpose of prevention and treatment of diseases by stimulating ear points, which are often carried out simultaneously in clinical practice.

Surgical observation group (Group B)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Research subjects: Surgical group: (1) Patients who were scheduled to undergo abdominal surgeries such as Whipple, pancreatectomy, and subtotal gastrectomy at Peking Union Medical College Hospital from June 2024 to June 2026. Health group: (2) Patients who visited the Health Examination Center of Peking Union Medical College Hospital from June 2024 to June 2026.

You may qualify if:

• \- 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.
• \) 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)

You may not qualify if:

• \) 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.
• 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).
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• weibin Wang

  Peking Union Medical College Hospital (CAMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

qianqian Shao

CONTACT

+8616601203165; mqd2022ky@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-08

Locations

CN (1)