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Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631160
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Tianjin First Central Hospital
Tianjin Beichen Hospital
Anyang People's Hospital
Information provided by (Responsible Party):
Jianbo Yu, Tianjin Nankai Hospital

Brief Summary:
  1. Title: Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative spontaneous voiding for Laparoscopic Cholecystectomy patients:A Randomized Clinical Trial
  2. Research center: Multicenter
  3. Design of the research: A randomized, double-blind and parallel controlled study
  4. Object of the research: Patients (40≤age<75 years)planing to elective laparoscopic cholecystectomy under general anesthesia without preoperative placement of catheter.
  5. Sample size of the research: A total of 1,200 patients,600 cases in each group
  6. Interventions: The acupuncture points for Transcutaneous Acupoint Electrical Stimulation(TAES) are Zhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6) and Ciliao ( BL32) points . In treatment group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at bilateral of SP6 and BL 32 points during the operation,and treated with a similar method at CV6 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. Each devic is connected and maintained after "Deqi". Participants in the control group received nonacupoints (located 1 inch beside acupoints) and avoided manual stimulation and no "Deqi" without actual current output.
  7. Aim of the research: Evaluate the effect of TAES on the postoperative spontaneous voiding in patients for Laparoscopic Cholecystectomy (LC ).
  8. Outcome:Primary outcomes: The time of the first spontaneous voiding after surgery .

    Secondary outcomes: symptoms of postoperative voiding, the incidence of Postoperative dysuria,postoperative catheterization rate, catheterization time, incidence of related complications,as well as the effects on postoperative NRS pain and sleep quality scores etc.

  9. The estimated duration of the study:2 years.

Condition or disease Intervention/treatment Phase
Voiding Disorders Device: TAES treatmen Device: Sham TAES treatmen Not Applicable

Detailed Description:
This study is a large sample, randomized, double-blinded, placebo-controlled and long-term follow-up design. In this study, bilateralZhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6) and Ciliao ( BL32) points were selected for perioperative TAES treatment, accompanied with evaluating the postoperative spontaneous voiding, the incidence of Postoperative dysuria,postoperative catheterization rate, as well as the effects on postoperative NRS pain and sleep quality scores . To clarify the effect of TAES on the postoperative spontaneous voiding in patients for laparoscopic surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1948 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients undergoing elective laparoscopy cholecystectomy surgery were recruited and allocated into TEAS(transcutaneous electrical acupoint stimulation)group or control group
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Subjects who have signed informed consent were assigned to either TEAS group or control group on the basis of digital random numbers generated by SPSS.23.0 software. The acupuncturist(Z.-Y.) was informed of the randomization allocation each subject by a concealed envelope, just before the onset of TEAS. And during the treatment, the screen of all acupuncture treatment instruments was covered from to ensure the anesthesiologist and surgeon blinded. The acupuncturist, statistician, and data collectors work independently and only perform assigned tasks, besides after the agreement is initiated, all researchers will not have any private communication with the study.
Primary Purpose: Treatment
Official Title: Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Cholecystectomy Patients:A Randomized Clinical Trial
Actual Study Start Date : August 20, 2018
Actual Primary Completion Date : June 17, 2020
Estimated Study Completion Date : November 22, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAES treatment
Patients in the treatment group receive Transcutaneous Acupoint Electrical Stimulation (TAES) at Zhongji ( CV3),Guanyuan ( CV4), bilaterally Sanyinjiao ( SP6) and bilaterally Ciliao ( BL32) points by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained until the end of treatment.
Device: TAES treatmen
In the acupoints group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at SP6 and BL 32 points during the operation in the operating room ,and at CV3 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. After "Deqi", electroacupuncture stimulation apparatus is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 milliamp (mA) (gradually increase to the patient's maximum tolerance) and maintained until the end of treatment.

Sham Comparator: Sham TAES treatment
Participants in the control group receive shallow TAES at SP6, BL32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the acuponit is shamed without manual stimulation and "Deqi" and the stimulation apparatus is inefficiency without actual current output.
Device: Sham TAES treatmen
Participants in the acupoints group receive shallow acupointing at SP6, BL 32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm).Specifically, the acupoint is shamed without manual stimulation and "Deqi" and the stimulation apparatus is inefficiency without actual current output .




Primary Outcome Measures :
  1. The first spontaneous voiding after surgery [ Time Frame: an average of 1 year ]
    Record the time from the end of the procedure to the patient's first spontaneous postoperatively, and record the amount of urine and discomfort


Secondary Outcome Measures :
  1. symptoms of postoperative voiding [ Time Frame: an average of 1 year ]
    The number of urination, total urine output and possible urinary discomfort symptoms during the perioperative period

  2. postoperative catheterization rate [ Time Frame: 12 months ]
    The incidence of catheterization in patients who were unable to urinate for a long time after surgery

  3. Incidence Urinary tract complications after surgery (including re-hospitalization) [ Time Frame: an average of 1 year ]
    Urinary retention, urinary incontinence, hematuria, urinary tract infection, etc.

  4. NRS pain scores [ Time Frame: 12 months ]
    NRS method is used to evaluate the pain scores of patients (0 points to complete Painless, 10 points to the maximum pain that can be tolerated) The NRS method was used to evaluate the pain scores of patients at resting state and activity (cough) 6-8 hours after operation.

  5. Anxiety and depression assessment [ Time Frame: an average of 1 year ]
    Using Hospital Anxiety and Depression Scale (HADS) to evaluate perioperative anxiety and depression of patients.HADS includes two scales of anxiety and depression, of which 0-7 is negative, 8-10 is mild, 11-14 is moderate, and 15-21 is severe.

  6. The effects on postoperative sleep quality scores [ Time Frame: 12 months ]
    Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep)

  7. Length of stay in hospital after surgery [ Time Frame: an average of 1 year ]
    The hospitalization time from the patient's surgery to the time of discharge (excluding re-hospitalization)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 40 years old and < 75 years old, gender and nationality are not limited;
  2. Patients undergoing elective laparoscopic cholecystectomy under general anesthesia
  3. agree to participate in this study and sign the informed consent;

Exclusion Criteria:

  1. Refused to participate in this study;
  2. laparotomy or preventive indwelling catheter;
  3. There are obvious symptoms of urinary difficulty caused by various causes recently;
  4. Patients who are have treatment taboo with skin injury or insensitivity to acupoint stimulation.
  5. Critical condition (preoperative ASA grade ≥ IV grade); severe renal impairment (need to undergo renal replacement therapy); severe liver and kidney dysfunction (Child-Pugh grade C);
  6. There are other circumstances where it is not appropriate to participate in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631160


Locations
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China, Tianjin
Tianjin Nankai Hospital
Tianjin, Tianjin, China, 300000
Sponsors and Collaborators
Tianjin Nankai Hospital
Tianjin First Central Hospital
Tianjin Beichen Hospital
Anyang People's Hospital
Investigators
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Study Chair: Jianbo Yu, MD,PhD Nankai Hospital of Tianjin
Publications of Results:
Other Publications:
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Responsible Party: Jianbo Yu, Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor, Tianjin Nankai Hospital
ClinicalTrials.gov Identifier: NCT03631160    
Other Study ID Numbers: TianjinNH Clinic
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All of the individual participant data collected during the trial,after deidentification will be shared.And anyone who wishes to acess the date will be available for any purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianbo Yu, Tianjin Nankai Hospital:
Laparoscopic Cholecystectomy
Transcutaneous Acupoint Electrical Stimulation
Postoperative spontaneous voiding
Postoperative Dysuria