The Effect of Acupoint Application on Postoperative Ileus

Not Applicable

• Conditions: Postoperative Ileus
• Interventions: Other: Acupoint application; Other: Fake acupoint application

• Registration Number: NCT04008667
• Lead Sponsor: li xiong

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.

Study Timeline

• Study First Submitted: 2019-06-29
• Status Verified: 2019-07
• Study Start: 2019-07
• Study First Submitted QC: 2019-07-02
• Last Update Submitted: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Acupoint application	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.
Placebo arm	Fake acupoint application	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
time to report of first flatus	End of surgery to the first flatus (from 1 to 5 days)	Defined as the first time flatus happens.
time to report of first defecation	End of surgery to the first defecation. (from 1 to 7 days)	Defined as the first time defecation happens.
length of postoperative hospitalization	End of surgery to hospital discharge. (from 5 to 7 days)	Defined as the length hospitalization after surgery
time to return of bowel sounds	End of surgery to the first bowel sound (from 1 to 5 days)	Defined as the first time hear the bowel sound after surgery.

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China