Acupuncture, EarNCT06580197
The Role of AAT After Abdominal Surgery Based on RWS
An observational study of Acupuncture, Ear and Gastroparesis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture, Ear, Gastroparesis
- What is being tested?
- Auricular Acupoint Therapy
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
- 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).
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Beijing Municipality, 100005
qindong Mi, 8616601203165, 785809127@qq.com
About this study
Official title: Application of Auricular Acupuncture Therapy Based on Real-World Studies After Abdominal Surgery
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
- Being tested
- Auricular Acupoint Therapy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupoint TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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)
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
Measured: 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
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.
Measured: Multiple time points before and after surgery
Patient Satisfaction with Pre-operative Preparation Assessed with the Visual Analogue Scale (VAS-Satisfaction)
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).
Measured: Preoperative
Visual Analogue Scale for Pain (VAS-Pain)
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.
Measured: Multiple time points after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Dec 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture, EarStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- weibin Wang, Principal investigator, Peking Union Medical College Hospital (CAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580197
- Sponsor's protocol ID
- K6357
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Auricular Acupuncture Therapy Based on Real-World Studies After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06580197
- Acronym / sponsor ID
- K6357
- Conditions
- Acupuncture, Ear, Gastroparesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Other: Auricular Acupoint TherapyPatients 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; |
| 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
- 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).
Key exclusion criteria (3 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Acupoint TherapyEar 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. | Other | Surgical observation group (Group B) |
Primary outcome
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%.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
weibin Wang principal investigator
Peking Union Medical College Hospital (CAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acupuncture, Ear and Gastroparesis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qianqian Shao (+8616601203165, mqd2022ky@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical total effective rate (time frame: On the third day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.