Clinical trial NCT04008667: The Effect of Acupoint Application on Postoperative Ileus
Official title: The Effect of Acupoint Application on Postoperative Ileus: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Ileus
Keywords: Postoperative ileus
acupoint
ERAS
Chinese medicine
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 540
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: time to defecate and tolerate for food (TF+D)
timeFrame: End of surgery to time to defecate and tolerate for food(from 5 to 7 days)
Secondary outcomes:
measure: time to return of bowel sounds
timeFrame: End of surgery to the first bowel sound (from 1 to 5 days)
measure: time to report of first flatus
timeFrame: End of surgery to the first flatus (from 1 to 5 days)
measure: time to report of first defecation
timeFrame: End of surgery to the first defecation. (from 1 to 7 days)
measure: length of postoperative hospitalization
timeFrame: End of surgery to hospital discharge. (from 5 to 7 days)
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: