The Effect of Acupoint Application on Postoperative Ileus

Sponsor
li xiong (Other)
Overall Status
Unknown status
CT.gov ID
NCT04008667
Collaborator
(none)
540
1
3
24
22.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Acupoint application
  • Other: Fake acupoint application
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
540 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Intervention arm:receiving acupoint application and regular therapy; Placebo arm: receiving fake acupoint application and regular therapy; control arm: receiving regular therapy.Intervention arm:receiving acupoint application and regular therapy; Placebo arm: receiving fake acupoint application and regular therapy; control arm: receiving regular therapy.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Acupoint Application on Postoperative Ileus: a Randomized Controlled Trial
Anticipated Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

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.

Outcome Measures

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)]

    Defined as the first time that the patient could both defecate and tolerate orally taking food after surgery.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. length of postoperative hospitalization [End of surgery to hospital discharge. (from 5 to 7 days)]

    Defined as the length hospitalization after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Patients are scheduled to undergo elective abdominal surgery;
    1. Patients age between 20 to 80 years old;
    1. Umbilical skin condition is good;
    1. Written informed consent provided to participate in the study.
Exclusion Criteria:
  • 1.Patients don't match the inclusion criteria;

    1. Patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ;
  • 3.Patients with mental disorder;

    1. Patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc;
    1. Patients received ostomy operation, such as jejunostomy;
  • 6.Patients who have history of abdominal surgery or history of bowel obstruction;

    1. Patients who receive other treatments to improve the gastrointestinal mobility or/and to relieve POI related symptoms , such as gastrointestinal prokinetic drugs, enema, etc.
    1. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Xiangya Hospital of Central South University Changsha Hunan China 410016

Sponsors and Collaborators

  • li xiong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
li xiong, Professor, Central South University
ClinicalTrials.gov Identifier:
NCT04008667
Other Study ID Numbers:
  • lxiong
First Posted:
Jul 5, 2019
Last Update Posted:
Jul 5, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by li xiong, Professor, Central South University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2019