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The Effect of Acupoint Application on Postoperative Ileus

The Effect of Acupoint Application on Postoperative Ileus: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04008667
Enrollment
540
Registered
2019-07-05
Start date
2019-07-31
Completion date
2021-07-31
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Keywords

Postoperative ileus, acupoint, ERAS, Chinese medicine

Brief summary

This study aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.

Detailed description

Postoperative ileus (POI) is a common disorder of gastrointestinal motility characterized by abdominal distension, nausea, vomiting and delayed passage of flatus or stool, which develops after every abdominal surgical procedure. POI increases risk of developing postoperative complications, decreases the bed turnover rate and prolongs the average duration of hospitalization, increasing the expense of both patients and hospitals. Although the Pathophysiological mechanism of POI remains unclear, recent researches suggests the inflammatory responses after surgery might be responsible for the gastrointestinal motility disorder. Acupoint application is a traditional chinese intervention which has been used in treating gastrointestinal motility disorder resulted from other causes. In this study, we aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.

Interventions

Acupoint application: The patients start using the acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.

OTHERFake acupoint application

Fake acupoint application: The patients start using the fake acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.

Sponsors

li xiong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Intervention arm:receiving acupoint application and regular therapy; Placebo arm: receiving fake acupoint application and regular therapy; control arm: receiving regular therapy.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 1\. Patients are scheduled to undergo elective abdominal surgery; * 2\. Patients age between 20 to 80 years old; * 3\. Umbilical skin condition is good; * 4\. Written informed consent provided to participate in the study.

Exclusion criteria

* 1.Patients don't match the inclusion criteria; * 2\. Patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ; * 3.Patients with mental disorder; * 4\. Patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc; * 5\. Patients received ostomy operation, such as jejunostomy; * 6.Patients who have history of abdominal surgery or history of bowel obstruction; * 7\. Patients who receive other treatments to improve the gastrointestinal mobility or/and to relieve POI related symptoms , such as gastrointestinal prokinetic drugs, enema, etc. * 8\. Patients who are allergic to the acupoint applicaton; * 9.Patients who are unsuitable for study inclusion as determined by the investigator. (eg: patients with severe operation related complications)

Design outcomes

Primary

MeasureTime frameDescription
time to defecate and tolerate for food (TF+D)End of surgery to time to defecate and tolerate for food(from 5 to 7 days)Defined as the first time that the patient could both defecate and tolerate orally taking food after surgery.

Secondary

MeasureTime frameDescription
time to return of bowel soundsEnd of surgery to the first bowel sound (from 1 to 5 days)Defined as the first time hear the bowel sound after surgery.
time to report of first flatusEnd of surgery to the first flatus (from 1 to 5 days)Defined as the first time flatus happens.
time to report of first defecationEnd of surgery to the first defecation. (from 1 to 7 days)Defined as the first time defecation happens.
length of postoperative hospitalizationEnd of surgery to hospital discharge. (from 5 to 7 days)Defined as the length hospitalization after surgery

Countries

China

Contacts

Primary Contactxiong Li, M.D
lixionghn@163.com+86-13787782059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026