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

Not Applicable

Completed

• Conditions: Voiding Disorders
• Interventions: Device: TAES treatmen; Device: Sham TAES treatmen

• Registration Number: NCT03631160
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-15
• Study Start: 2018-08-20
• Primary Completion: 2020-06-21
• Study Completion: 2020-08-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1948

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAES treatment	TAES treatmen	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.
Sham TAES treatment	Sham TAES treatmen	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.

Primary Outcome Measures

Name	Time	Method
The first spontaneous voiding after surgery	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

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

Trial Locations

Locations (1)

Tianjin Nankai Hospital; 🇨🇳 Tianjin, Tianjin, China