The Effect of Acupoint Application on Postoperative Ileus

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04008667
• Other study ID #: lxiong
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: July 2021

Study information

• Verified date: July 2019
• Source: Central South University
• Contact: xiong Li, M.D
• Phone: +86-13787782059
• Email: lixionghn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
li xiong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to defecate and tolerate for food (TF+D)	Defined as the first time that the patient could both defecate and tolerate orally taking food after surgery.	End of surgery to time to defecate and tolerate for food(from 5 to 7 days)
Secondary	time to return of bowel sounds	Defined as the first time hear the bowel sound after surgery.	End of surgery to the first bowel sound (from 1 to 5 days)
Secondary	time to report of first flatus	Defined as the first time flatus happens.	End of surgery to the first flatus (from 1 to 5 days)
Secondary	time to report of first defecation	Defined as the first time defecation happens.	End of surgery to the first defecation. (from 1 to 7 days)
Secondary	length of postoperative hospitalization	Defined as the length hospitalization after surgery	End of surgery to hospital discharge. (from 5 to 7 days)