Clinical trial NCT03631160: Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients
Official title: Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Cholecystectomy Patients：A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voiding Disorders
Keywords: Laparoscopic Cholecystectomy
Transcutaneous Acupoint Electrical Stimulation
Postoperative spontaneous voiding
Postoperative Dysuria
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin First Central Hospital
name: Tianjin Beichen Hospital
name: Anyang People's Hospital
First posted: 2018-08-15
Enrollment: 1948
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients undergoing elective laparoscopy cholecystectomy surgery were recruited and allocated into TEAS（transcutaneous electrical acupoint stimulation）group or control group
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The first spontaneous voiding after surgery
timeFrame: an average of 1 year
Secondary outcomes:
measure: symptoms of postoperative voiding
timeFrame: an average of 1 year
measure: postoperative catheterization rate
timeFrame: 12 months
measure: Incidence Urinary tract complications after surgery (including re-hospitalization)
timeFrame: an average of 1 year
measure: NRS pain scores
timeFrame: 12 months
measure: Anxiety and depression assessment
timeFrame: an average of 1 year
measure: The effects on postoperative sleep quality scores
timeFrame: 12 months
measure: Length of stay in hospital after surgery
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
Study officials:
affiliation: Nankai Hospital of Tianjin
name: Jianbo Yu, MD,PhD
role: STUDY_CHAIR
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