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NCT Number: NCT06580197

The Role of AAT After Abdominal Surgery Based on RWS

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking union medical college hospital

Beijing, Beijing Municipality, 100005, China

Location status: Recruiting

Location contact

qindong Mi

CONTACT

[email protected]

8616601203165

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical total effective rate

    Time frame: 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%.

  2. 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

    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.

Secondary outcomes

  1. 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

    To accommodate the short treatment duration and unique ward environment of hospitalized patients, this study modified the Pittsburgh Sleep Quality Index (PSQI) to develop an adapted version (M-PSQI) for short-term sleep assessment. The scale consists of 24 items (19 self-rated + 5 caregiver-rated), with scoring based on the 19 self-rated items, which assess the following dimensions:

    • Sleep Process Metrics: Sleep latency, total sleep duration, wake time
    • Sleep Disturbance Manifestations: Difficulty falling asleep, nocturnal awakening frequency, environmental/physiological sleep disruptions
    • Subjective Sleep Quality: Patients' overall evaluation of sleep quality
    • Medication Use: Frequency of sedative-hypnotic drug use
    • Daytime Functional Impairment: Difficulty maintaining wakefulness, reduced task performance efficiency The scale adopts a 7-factor structure, with each factor scored on a 0-3 scale. The total score ranges from 0 to 21, with higher scores indicating more severe sleep
  2. Self-Rating Anxiety Scale (SAS) Score

    Time frame: Multiple time points before and after surgery

    The Self-Rating Anxiety Scale (SAS) was used to comprehensively evaluate the baseline anxiety levels of patients undergoing total knee arthroplasty (TKA) before surgery.

    Key Features of the SAS:

    Assessment Period: The scale assesses the patient's anxiety levels over the past week.

    Scoring Method: Forward-scoring items: Responses A, B, C, and D are scored as 1, 2, 3, and 4 points, respectively. Reverse-scoring items: Responses are scored as 4, 3, 2, and 1 points, respectively. The reverse-scored items are 5, 9, 13, 17, and 19 (highlighted in bold in the table below).All other items are forward-scored.

    Score Calculation and Interpretation: The raw score is obtained by summing the scores of all 20 items. The raw score is then multiplied by 1.25 and rounded to the nearest whole number to derive the standard score. The cutoff value for anxiety is 50. Higher scores indicate more pronounced anxiety tendencies.

    50-59: Mild anxiety 60-69: Moderate anxiety 70 and above: Severe anxiety.

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

    Time frame: Preoperative

    The Visual Analogue Scale for Satisfaction (VAS-Satisfaction) is a simple, validated tool used to measure a patient's subjective satisfaction with their pre-operative preparation. It consists of a 100-mm horizontal line anchored by two extreme statements: Left anchor (0 mm): "Not satisfied at all"; Right anchor (100 mm): "Completely satisfied".

    The patient marks a point on the line corresponding to their level of satisfaction with the pre-operative process (This includes the information provided before surgery, the attitude of the medical staff, the arrangement of the preoperative process, and the overall experience of preoperative preparation). The score is quantified by measuring the distance (in mm) from the left anchor to the patient's mark, yielding a numerical value between 0 (lowest satisfaction) and 100 (highest satisfaction).

  4. Visual Analogue Scale for Pain (VAS-Pain)

    Time frame: Multiple time points after surgery

    The Visual Analogue Pain Score (VAS-Pain) is a tool used to quantify a patient's subjective pain intensity using a straight line of 100 millimeters (10 cm) with two ends representing "no pain" and "most severe pain", and the patient assesses their pain level by marking their position on the straight line.

Study contacts

Contact information is provided by the study sponsor or research team.

qianqian Shao

CONTACT

[email protected]

+8616601203165

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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