The Effect of Acupoint Application on Postoperative Ileus
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2019 |
| First Submitted: | 06/28/2019 |
| Estimated Enrollment Submitted: | 07/01/2019 |
| First Posted: | 07/04/2019 |
| Last Update Submitted: | 07/01/2019 |
| Last Update Posted: | 07/04/2019 |
| Actual Study Start Date: | 06/30/2019 |
| Estimated Primary Completion Date: | 06/30/2021 |
| Estimated Study Completion Date: | 06/30/2021 |
Condition or disease
Intervention/treatment
Other: Intervention arm
Other: Placebo arm
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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. | Other: Intervention arm 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 Comparator: 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. | Other: Placebo arm 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. |
| No Intervention: 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. |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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) |
Outcome
Primary Outcome Measures
1. 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)]
Secondary Outcome Measures
1. time to return of bowel sounds [End of surgery to the first bowel sound (from 1 to 5 days)]
2. time to report of first flatus [End of surgery to the first flatus (from 1 to 5 days)]
3. time to report of first defecation [End of surgery to the first defecation. (from 1 to 7 days)]
4. length of postoperative hospitalization [End of surgery to hospital discharge. (from 5 to 7 days)]
