The Effect of Acupoint Application on Postoperative Ileus

li xiong

Status: Unknown

Conditions: Postoperative Ileus

Treatments: Other: Acupoint application; Other: Fake acupoint application

Study type: Interventional

Funder types: Other

Identifiers

NCT04008667

lxiong

Details and patient eligibility

About

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

Full 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.

Enrollment: 540 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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540 participants in 3 patient groups, including a placebo group

Intervention arm

Experimental group

Description:

Receiving the acupoint application and optimal supports. 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. All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc.

Treatment:

Other: Acupoint application

Placebo arm

Placebo Comparator group

Description:

Receiving the fake acupoint application and optimal supports. The fake acupoint is 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. All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc.

Treatment:

Other: Fake acupoint application

Control arm

No Intervention group

Description:

Receiving the optimal supports. All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc.