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

Study Overview
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Brief Summary
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Title: Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative spontaneous voiding for Laparoscopic Cholecystectomy patients：A Randomized Clinical Trial Research center: Multicenter Design of the research: A randomized, double-blind and parallel controlled study Object of the research: Patients （40≤age<75 years）planing to elective laparoscopic cholecystectomy under general anesthesia without preoperative placement of catheter. Sample size of the research: A total of 1,200 patients,600 cases in each group 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. Aim of the research: Evaluate the effect of TAES on the postoperative spontaneous voiding in patients for Laparoscopic Cholecystectomy (LC ). 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. The estimated duration of the study：2 years.

Detailed Description
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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.

Official Title
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Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Cholecystectomy Patients：A Randomized Clinical Trial

Conditions
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Voiding Disorders

Intervention / Treatment
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* Device: TAES treatmen
* Device: Sham TAES treatmen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years old and < 75 years old, gender and nationality are not limited; Patients undergoing elective laparoscopic cholecystectomy under general anesthesia agree to participate in this study and sign the informed consent; Exclusion Criteria: Refused to participate in this study; laparotomy or preventive indwelling catheter; There are obvious symptoms of urinary difficulty caused by various causes recently; Patients who are have treatment taboo with skin injury or insensitivity to acupoint stimulation. 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); There are other circumstances where it is not appropriate to participate in this study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients undergoing elective laparoscopy cholecystectomy surgery were recruited and allocated into TEAS（transcutaneous electrical acupoint stimulation）group or control group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAES treatment<br>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<br>* 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.<br>|
| Sham Comparator: Sham TAES treatment<br>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<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The first spontaneous voiding after surgery | Record the time from the end of the procedure to the patient's first spontaneous postoperatively, and record the amount of urine and discomfort | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms of postoperative voiding | The number of urination, total urine output and possible urinary discomfort symptoms during the perioperative period | an average of 1 year | 
| postoperative catheterization rate | The incidence of catheterization in patients who were unable to urinate for a long time after surgery | 12 months | 
| Incidence Urinary tract complications after surgery (including re-hospitalization) | Urinary retention, urinary incontinence, hematuria, urinary tract infection, etc. | an average of 1 year | 
| NRS pain scores | 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. | 12 months | 
| Anxiety and depression assessment | 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. | an average of 1 year | 
| The effects on postoperative sleep quality scores | Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep) | 12 months | 
| Length of stay in hospital after surgery | The hospitalization time from the patient's surgery to the time of discharge (excluding re-hospitalization) | an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Cholecystectomy, Transcutaneous Acupoint Electrical Stimulation, Postoperative spontaneous voiding, Postoperative Dysuria