The Effect of Acupoint Application on Postoperative Ileus

NCT04008667 | Unknown DMC

• 1 other identifier: lxiong
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Ileus

Keywords

Postoperative ileus; acupoint; ERAS; Chinese medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• time to return of bowel sounds

  End of surgery to the first bowel sound (from 1 to 5 days)

• time to report of first flatus

  End of surgery to the first flatus (from 1 to 5 days)

• time to report of first defecation

  End of surgery to the first defecation. (from 1 to 7 days)

• length of postoperative hospitalization

  End of surgery to hospital discharge. (from 5 to 7 days)

Study Arms (3)

Intervention arm

EXPERIMENTAL

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

Placebo arm

PLACEBO COMPARATOR

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

Control arm

NO INTERVENTION

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.

Interventions

Acupoint application OTHER

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 arm

Fake acupoint application OTHER

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.

Placebo arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients are scheduled to undergo elective abdominal surgery;
• \. Patients age between 20 to 80 years old;
• \. Umbilical skin condition is good;
• \. Written informed consent provided to participate in the study.

You may not qualify if:

• \. Patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ;
• Patients with mental disorder;
• \. Patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc;
• \. Patients received ostomy operation, such as jejunostomy;
• Patients who have history of abdominal surgery or history of bowel obstruction;
• \. Patients who receive other treatments to improve the gastrointestinal mobility or/and to relieve POI related symptoms , such as gastrointestinal prokinetic drugs, enema, etc.
• \. Patients who are allergic to the acupoint applicaton;

Sponsors & Collaborators

• li xiong: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410016, China

Location

Central Study Contacts

xiong Li, M.D

CONTACT

+86-13787782059; lixionghn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Intervention arm：receiving acupoint application and regular therapy; Placebo arm: receiving fake acupoint application and regular therapy; control arm: receiving regular therapy.

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 5, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)