TEAS Enhanced Recovery After Laparoscopic Colon Surgery

NCT02921529 | Completed DMC

• 1 other identifier: XJH-A-2016-09-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to observe the effects of transcutaneous electrical acupoint stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery.

Conditions

Postoperative Recovery

Keywords

Postoperative recovery; colon surgery

Outcome Measures

Primary Outcomes (1)

• Time to meeting discharge criteria

  end of the surgery to discharge,with an average of 7 days

Secondary Outcomes (9)

• Time to first flatus

  end of the surgery to discharge,with an average of 7 days

• Time to first defecation

  end of the surgery to discharge,with an average of 7 days

• Incidence of postoperative complications

  end of the surgery to discharge,with an average of 7 days

• Time to first oral intake of water

  end of the surgery to discharge,with an average of 7 days

• visual analogue scale

  end of surgery to 24 hours, 48 hours, and 72 hours after surgery

Study Arms (2)

TEAS

EXPERIMENTAL

Patients were given 30min of TEAS(transcutaneous electrical acupoint stimulation) before anesthesia and 1,2,3 day after surgery

Other: TEAS

false stimulation

SHAM COMPARATOR

Attach electrodes without electric current

Other: false stimulation

Interventions

TEAS OTHER

Electric stimulation was given through electrode attached to specific acupoints

Also known as: Acupuncture, Electric stimulation

TEAS

false stimulation OTHER

Electrodes were attached to specific acupoints without electric current

Also known as: sham stimulation

false stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 to 75 years old；
• ASA I-III；
• Scheduled for elective laparoscopic colon surgery under general anesthesia；
• BMI between 18 and 30；
• Informed consented.

You may not qualify if:

• Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints；
• Patients with difficulty in communication；
• Emergency surgery；
• Patients who are with distant metastasis;
• Patients who are with history of myocardial infarction or cerebral infarction in the past six months；
• Patients who are with long history of taking NSAIDS，hormone or immunosuppressive agents；
• Patients who are recruited in other clinical trials in the last 3 months；
• Other situations researcher think shouldn't be included.

Sponsors & Collaborators

• Zhihong LU: lead

Study Sites (3)

First Afiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Tongji Hospital

Wuhan, Hubei, China

Location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Interventions

Acupuncture Therapy; Electric Stimulation

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Inventions were given by an investigator who is not involved in patient care. The anesthetists, surgeons,staff in the ward, the one who record the outcomes, and data analyzer were all blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 3, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (3)