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To investigate the effect and mechanism of auricular acupoint stimulation in improving postoperative gastrointestinal function based on LHA-DVC-gastrointestinal axis

Registration number：

ITMCTR2025000564

Date of Last Refreshed on：

2025-03-20

Date of Registration：

2025-03-20

Registration Status：

Prospective registration

Public title：

To investigate the effect and mechanism of auricular acupoint stimulation in improving postoperative gastrointestinal function based on LHA-DVC-gastrointestinal axis

English Acronym：

Scientific title：

To investigate the effect and mechanism of auricular acupoint stimulation in improving postoperative gastrointestinal function based on LHA-DVC-gastrointestinal axis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Wang Fen

Study leader：

Tian Weiqian

Applicant telephone：

+86 150 0515 2864

Study leader's telephone：

+86 139 1476 4426

Applicant Fax：

Study leader's fax：

Applicant E-mail：

docwangfen@126.com

Study leader's E-mail：

twq1972@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

Study leader's address：

155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Affiliated Hospital of Nanjing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2025NL-040-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine

Date of approved by ethic committee：

2025/2/10 0:00:00

Contact Name of the ethic committee：

Wang Mao

Contact Address of the ethic committee：

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Contact phone of the ethic committee：

+86 25 8656 0515

Contact email of the ethic committee：

llwyhbgs@qq.com

Primary sponsor：

Affiliated Hospital of Nanjing University of Chinese Medicine

Primary sponsor's address：

155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

Secondary sponsor：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution
hospital：

Affiliated Hospital of Nanjing University of Chinese Medicine

Address：

155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

Source(s) of funding：

Jiangsu Provincial Health Commission

Target disease：

Postoperative gastrointestinal dysfunction

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To explore the effect of auricular acupuncture in postoperative gastrointestinal dysfunction and gastrointestinal transit function.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Patients undergoing gastrointestinal tumor resection under general anesthesia; 2. Meet the American Society of Anesthesiologists (ASA) grade II to III; 3. Age 40-88 years old; 4. Voluntarily participate in this study and sign the informed consent.

Exclusion criteria：

1. Patients with contraindications of auricular intradermal needling such as redness ulceration inflammation or metal allergy in the corresponding part of the skin; 2. complicated with other important organic diseases; 3. Emergency surgery and secondary surgery; 4. Postoperative infection anastomotic leakage and other complications; 5. Patients with water and electrolyte metabolism disorders and severe anemia before operation; 6. Those who have cognitive impairment and cannot communicate normally.

Study execute time：

From 2025-04-01

To      2026-02-10

Recruiting time：

From 2025-04-01

To      2026-02-10

Interventions：

40

Group：

auricular acupuncture

Sample size：

Intervention：

The patient was treated with ear acupuncture intervention for 3 days after surgery.

Intervention code：

40

Group：

sham auricular acupuncture

Sample size：

Intervention：

The patient's ear point was affixed with the same appearance as the acupuncture group but without needles for 3 days after surgery

Intervention code：

Total sample size ： 80

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution/hospital：

Affiliated Hospital of Nanjing University of Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Time of first postoperative defecation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The postoperative peripheral serum levels of brain-gut peptide, gastrin (GAS), motilin (MTL), and orexin A detected by ELISA.

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative bowel sound recovery time

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Gastrointestinal quality of life index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative hospital stay: Time from operation to discharge was recorded

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of postoperative abdominal distension

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of postoperative nausea and vomiting

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Time of first postoperative fart

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Peripheral Venous Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

40
Min age years
88
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Independent researchers used computer Excel software to generate a random number table, and the patients were randomly divided into the press test group and the control group in a 1:1 ratio.

Blinding：

None

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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