The Effect of Acupoint Application on Postoperative Ileus

NCT ID: NCT04008667

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2021-07-31

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.

Conditions

Postoperative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention arm

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.

Group Type: EXPERIMENTAL

Acupoint application

Intervention Type: OTHER

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.

Placebo arm

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.

Group Type: PLACEBO_COMPARATOR

Fake acupoint application

Intervention Type: OTHER

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.

Control arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupoint application

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.

Intervention Type: OTHER

Fake 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.

Intervention Type: OTHER

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.

• 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

li xiong

OTHER

Sponsor Role: lead

Responsible Party

li xiong

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Central Contacts

xiong Li, M.D

Role: CONTACT

lixionghn@163.com

+86-13787782059

Facility Contacts

Xiong Li, M.D

Role: primary

lixionghn@163.com

Other Identifiers

lxiong

Identifier Type: -

Identifier Source: org_study_id