The Role of AAT on DGE After Abdominal Surgery Based on RWS

Recruiting

• Conditions: Acupuncture, Ear; Gastroparesis
• Interventions: Other: Auricular Acupoint Therapy

• Registration Number: NCT06580197
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Study Start: 2024-12-01
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 159

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:

1. Age range: 40-70 years old (40 ≤ y ≤ 70), gender is not limited.
2. No history of abdominal surgery or tumor, and no significant abnormalities were found through abdominal imaging examination.
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. Symptoms of digestive discomfort such as diarrhea, constipation, and vomiting have been present for the past 30 days.
2. The patient has conditions such as damage, redness, bleeding, and infection in both ears that affect the assessment of ear acupoint information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical observation group (Group B)	Auricular Acupoint Therapy	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;

Primary Outcome Measures

Name	Time	Method
Clinical total effective rate	On the third day after surgery	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%.

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, Beijing, China