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

NCT03631160 | Completed

• 1 other identifier: TianjinNH Clinic
• Study Type: interventional
• Target: 1,948
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Voiding Disorders

Keywords

Laparoscopic Cholecystectomy; Transcutaneous Acupoint Electrical Stimulation; Postoperative spontaneous voiding; Postoperative Dysuria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• symptoms of postoperative voiding

  an average of 1 year

• postoperative catheterization rate

  12 months

• Incidence Urinary tract complications after surgery (including re-hospitalization)

  an average of 1 year

• NRS pain scores

  12 months

• Anxiety and depression assessment

  an average of 1 year

Study Arms (2)

TAES treatment

EXPERIMENTAL

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

Sham TAES treatment

SHAM COMPARATOR

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

Interventions

TAES treatmen DEVICE

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.

TAES treatment

Sham TAES treatmen DEVICE

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 .

Sham TAES treatment

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead
• Tianjin First Central Hospital: collaborator
• Tianjin Beichen Hospital: collaborator
• Anyang People's Hospital: collaborator

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (9)

• Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.

  PMID: 28655016 BACKGROUND

• Arvidsdotter T, Marklund B, Taft C. Six-month effects of integrative treatment, therapeutic acupuncture and conventional treatment in alleviating psychological distress in primary care patients--follow up from an open, pragmatic randomized controlled trial. BMC Complement Altern Med. 2014 Jun 30;14:210. doi: 10.1186/1472-6882-14-210.

  PMID: 24980440 BACKGROUND

• Chao AS, Chao A, Wang TH, Chang YC, Peng HH, Chang SD, Chao A, Chang CJ, Lai CH, Wong AMK. Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor: a randomized double-blind placebo-controlled trial. Pain. 2007 Feb;127(3):214-220. doi: 10.1016/j.pain.2006.08.016. Epub 2006 Oct 6.

  PMID: 17030438 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Lee SJ, Hyung WJ, Koo BN, Lee JY, Jun NH, Kim SC, Kim JW, Liu J, Kim KJ. Laparoscopy-assisted subtotal gastrectomy under thoracic epidural-general anesthesia leading to the effects on postoperative micturition. Surg Endosc. 2008 Mar;22(3):724-30. doi: 10.1007/s00464-007-9475-6.

  PMID: 17661136 BACKGROUND

• Partelli S, Barugola G, Sartori A, Crippa S, Falconi M, Ruffo G. Single-incision laparoscopic cholecystectomy versus traditional laparoscopic cholecystectomy performed by a single surgeon: findings of a randomized trial. Surg Today. 2016 Mar;46(3):313-8. doi: 10.1007/s00595-015-1182-7. Epub 2015 Jun 3.

  PMID: 26036221 RESULT

• Hata T, Noda T, Shimizu J, Hatano H, Dono K. Omitting perioperative urinary catheterization in laparoscopic cholecystectomy: a single-institution experience. Surg Today. 2017 Aug;47(8):928-933. doi: 10.1007/s00595-016-1454-x. Epub 2016 Dec 9.

  PMID: 27943036 RESULT

• Hawkes N. Cochrane reviews evidence on surgery for stress incontinence after controversy in Scotland. BMJ. 2015 Jul 2;351:h3578. doi: 10.1136/bmj.h3578. No abstract available.

  PMID: 26139091 RESULT

• Zhang YF, Li XY, Liu XY, Zhang Y, Gong LR, Shi J, Du SH, He SM, Li C, Li YT, Li N, Liu SS, Wu Y, Xie ZL, Pei ZC, Yu JB. Transcutaneous Electrical Acupoints Stimulation Improves Spontaneous Voiding Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial. World J Surg. 2023 May;47(5):1153-1162. doi: 10.1007/s00268-023-06924-7. Epub 2023 Feb 6.

  PMID: 36745198 DERIVED

Study Officials

• Jianbo Yu, MD,PhD

  Nankai Hospital of Tianjin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Model Details: patients undergoing elective laparoscopy cholecystectomy surgery were recruited and allocated into TEAS（transcutaneous electrical acupoint stimulation）group or control group

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 15, 2018
• Study Start: August 20, 2018
• Primary Completion: June 21, 2020
• Study Completion: August 24, 2020
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)