The Effect of Acupoint Application on Postoperative Ileus

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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Ileus
• Intervention / Treatment: Other: Acupoint application; Other: Fake acupoint application

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 Type: Interventional
• Enrollment (Anticipated): 540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xiong Li, M.D; Phone Number: +86-13787782059; Email: lixionghn@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410016
      • The Second Xiangya Hospital of Central South University
      • Contact: Xiong Li, M.D; Email: lixionghn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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.
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
length of postoperative hospitalization	Defined as the length hospitalization after surgery	End of surgery to hospital discharge. (from 5 to 7 days)

Collaborators and Investigators

• Sponsor: li xiong

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: ERAS; Chinese medicine; Postoperative ileus; acupoint
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: lxiong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No