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The Effect of Acupoint Application on Postoperative Ileus

Primary Purpose

Postoperative Ileus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupoint application
Fake acupoint application
Sponsored by
li xiong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring Postoperative ileus, acupoint, ERAS, Chinese medicine

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Second Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Intervention arm

Placebo arm

Control arm

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

time to return of bowel sounds
Defined as the first time hear the bowel sound after surgery.
time to report of first flatus
Defined as the first time flatus happens.
time to report of first defecation
Defined as the first time defecation happens.
length of postoperative hospitalization
Defined as the length hospitalization after surgery

Full Information

First Posted
June 29, 2019
Last Updated
July 2, 2019
Sponsor
li xiong
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1. Study Identification

Unique Protocol Identification Number
NCT04008667
Brief Title
The Effect of Acupoint Application on Postoperative Ileus
Official Title
The Effect of Acupoint Application on Postoperative Ileus: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
li xiong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Postoperative ileus, acupoint, ERAS, Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention arm：receiving acupoint application and regular therapy; Placebo arm: receiving fake acupoint application and regular therapy; control arm: receiving regular therapy.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupoint application
Intervention Description
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
Intervention Name(s)
Fake acupoint application
Intervention Description
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.
Primary Outcome Measure Information:
Title
time to defecate and tolerate for food (TF+D)
Description
Defined as the first time that the patient could both defecate and tolerate orally taking food after surgery.
Time Frame
End of surgery to time to defecate and tolerate for food(from 5 to 7 days)
Secondary Outcome Measure Information:
Title
time to return of bowel sounds
Description
Defined as the first time hear the bowel sound after surgery.
Time Frame
End of surgery to the first bowel sound (from 1 to 5 days)
Title
time to report of first flatus
Description
Defined as the first time flatus happens.
Time Frame
End of surgery to the first flatus (from 1 to 5 days)
Title
time to report of first defecation
Description
Defined as the first time defecation happens.
Time Frame
End of surgery to the first defecation. (from 1 to 7 days)
Title
length of postoperative hospitalization
Description
Defined as the length hospitalization after surgery
Time Frame
End of surgery to hospital discharge. (from 5 to 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiong Li, M.D
Phone
+86-13787782059
Email
lixionghn@163.com
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410016
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiong Li, M.D
Email
lixionghn@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Acupoint Application on Postoperative Ileus

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