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  • Status : Approved
    • First Submitted Date : 2015/05/06
    • Registered Date : 2015/05/14
    • Last Updated Date : 2015/05/14
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1. Background

Background Information
CRIS
Registration Number
KCT0001486 
Unique Protocol ID 110757-201410-HR-04 
Public/Brief Title Effects of electroacupuncture on postoperative pain and gastrointestinal motility after laparoscopic appendectomy 
Scientific Title Effects of electroacupuncture on postoperative pain and gastrointestinal motility after laparoscopic appendectomy  
Acronym AcuLap 
MFDS Regulated Study No
IND/IDE Protocol
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 110757-201410-HR-04-04 
Approval Date 2014-10-15 
Institutional Review Board  
Name Dongguk University Gyeongju Hospital Institutional Review Board 
Address  
Telephone  
Data Monitoring Committee  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Gangmi Kim 
Title M.D. 
Telephone  
Affiliation Dongguk University Gyeongju Hospital 
Address  
Contact Person for Public Queries
Name Gangmi Kim 
Title M.D. 
Telephone  
Affiliation Dongguk University Gyeongju Hospital 
Address  
Contact Person for Updating Information
Name Gangmi Kim 
Title M.D. 
Telephone  
Affiliation Dongguk University Gyeongju Hospital 
Address  

4. Status

Status Information
Study Site Single
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2015-05-18 , Anticipated
Target Number of Participant 87
Primary Completion Date 2016-05-17 , Anticipated
Study Completion Date 2016-05-17 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Dongguk University Gyeongju Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2015-05-18 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Daegu-Gyeongbuk Surgical Society  
Organization Type Others  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Dongguk University Gyeongju Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Purpose <br />: To evaluate the effect of electroacupuncture on postoperative pain relief and bowel motility recovery in patients with appendicitis after laparoscopic appendectomy. <br /> <br />Background <br />: With advances in surgery, Enhanced Recovery After Surgery (ERAS) program enables faster recovery after surgery. The theoretical background of ERAS program is that minimizing pain and stress in patients undergoing surgery prevents organ dysfunction and complications and consequently enhances faster recovery. The clinical significance of ERAS program has been proven via many clinical studies. Early enteral feeding with fast bowel motility recovery, and resultant fast recovery and shortened hospital stay are advantages of ERAS program. <br />The five key elements of ERAS program are 1) patient information; 2) preservation of gastrointestinal function; 3) minimization of organ dysfunction; 4) active pain control; and 5) promotion of patient autonomy of which we focused on clinical factors 2), 3), and 4). Literature review revealed that electroacupuncture might have positive effects on postoperative bowel motility recovery and pain control. <br />Accordingly, we assumed that electroacupuncture, which is not included in existing ERAS program, could accelerate recovery after surgery by means of postoperative pain control and faster bowel motility recovery. This study aims to evaluate the effect of electroacupuncture in patients with appendicitis after laparoscopic appendectomy. <br /> <br />Materials & Methods: <br />Inclusion criteria are 1) patients diagnosed as appendicitis; 2) female or male patients over 20 years old; and 3) patients undergoing laparoscopic appendectomy. <br /> <br />Study design is a prospective randomized controlled trial with three-arm, parallel-group. <br />1) Arm 1 = electroacupuncture group <br />2) Arm 2 = sham acupuncture group <br />3) Arm 3 = control group <br />Patients after laparoscopic appendectomy are devided as three groups: 1) electroacupuncture; 2) sham acupuncture; and 3) no acupuncture. Postoperative pain score and bowel motility recovery are evaluated in each groups. <br /> <br />Interventions: <br />1) Intervention 1 = electroacupuncture <br />Materials: Stainless-steel needle and PG-306 electroacupuncture device <br />Methods: At least two hours after operation, electroacupuncture for 30 minutes, twice a day (a.m. & p.m.). Maximum 6 times of acupuncture during hospitalization. <br />Acupuncture site (location): LI4(Hapgok, Hegu), PC6(Naegwan, Neiguan), KI6(Johae, Zhaohai), and LR3(Taechung, Taichong). <br />2) Intervention 2 = sham acupuncture <br />Materials: Park Sham Device (PSD) <br />Methods & acupuncture location: same as electroacupuncture group <br />3) Control group = No postoperative acupuncture <br /> <br />Outcomes <br />1) Primary outcome – Time of first passing flatus after operation <br />2) Secondary outcomes – Postoperative pain score, bowel sound per minute, postoperative nausea and/or vomiting, time to tolerable water drinking and solid diet after operation, postoperative analgesics, postoperative complications, readmission rate due to postoperative complications, time to mobilization(self walking) and self support to preoperative level, postoperative quality of life questionnaire, postoperative hospital stay, total cost during hospital stay after operation, protocol failure rate <br />  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Phase2 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type /Procedure/Surgery  
Intervention Description Prospective randomized controlled trial with three-arm, parallel-group. <br /> <br />1. Intervention 1 = electroacupuncture <br />Materials: Stainless-steel needle and PG-306 electroacupuncture device <br />Methods: At least two hours after operation, electroacupuncture for 30 minutes, twice a day (a.m. & p.m.). Maximum 6 times of acupuncture during hospitalization. <br />Acupuncture site (location): LI4(Hapgok, Hegu), PC6(Naegwan, Neiguan), KI6(Johae, Zhaohai), and LR3(Taechung, Taichong). <br /> <br />2. Intervention 2 = sham acupuncture <br />Materials: Park Sham Device (PSD) <br />Methods & acupuncture location: same as electroacupuncture group <br /> <br />3. Control group = No postoperative acupuncture <br /> <br />4. Blinding for electroacupuncture vs. sham acupuncture <br />1) Electroacupuncture : <br />Acupuncture with stainless-steel needle (0.25X40mm, DONGBANG Acupuncture Inc., Korea) and electrostimulation with PG-306 electroacupuncture device (Tokyo, Japan). <br />2) Sham acupuncture: <br />Acupuncture with Park Sham Device (PSD). <br />PSD is composed of guide tube and Park tube through which needle is inserted. Sham needle has a blunt end which cannot penetrate skin. However, needle is inserted into the tube and it appears to be shortened so it looks like penetrating skin. <br />3) Real electroacupuncture set and sham acupuncture set (PSD) are identical in shape. Patients are unable to distinguish between real electroacupuncture and sham acupuncture because they have same shape and same sound (fake electrostimulation sound). <br /> <br />5. Blinding for allocation: <br />True electroacupuncture vs. sham acupuncture : blinded <br />Intervention group (true & sham acupuncture) vs. control group : open  
Number of Arms
Arm 1 Arm Label Electroacupuncture group 
Target Number of Participant 29 
Arm Type Experimental 
Arm Description Materials: Stainless-steel needle and PG-306 electroacupuncture device Methods: At least two hours after operation, electroacupuncture for 30 minutes, twice a day (a.m. & p.m.). Maximum 6 times of acupuncture during hospitalization. Acupuncture site (location): LI4(Hapgok, Hegu), PC6(Naegwan, Neiguan), KI6(Johae, Zhaohai), and LR3(Taechung, Taichong).  
Arm 2 Arm Label Sham acupunture group 
Target Number of Participant 29 
Arm Type Sham comparator 
Arm Description Materials: Park Sham Device (PSD) Methods & acupuncture location: same as electroacupuncture group 
Arm 3 Arm Label Control group 
Target Number of Participant 29 
Arm Type No intervention 
Arm Description No postoperative acupuncture. Postoperative care is provided as in laparoscopic appendectomy. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the digestive system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ No Limit
Description 1. Patients diagnosed as appendicitis <br />2. Female or male patients over 20 years old <br />3. Patients undergoing laparoscopic appendectomy  
Exclusion Criteria 1. Patients who need simultaneous combined surgery (including ileocecectomy) <br />2. Patients diagnosed with combined other diseases as well as appendicitis, preoperatively or intrapoperatively (e.g. colonic diverticulitis, inflammator bowel disease, pelvic inflammatory disease, etc.) <br />3. Patients who need postoperative fasting according to preoperative evaluation or intraoperative findings (e.g. panperitonitis with intraperitoneal abscess) <br />4. Patients under treatment for acute disease other than appendicitis <br />5. Patients converted to open surgery <br />6. Patients with cardiac pacemaker <br />7. Patients with allergy to or phobia of acupuncture needle or electrostimulation <br />8. Patients with history of syncope or seizure <br />9. Pregnant women or lactating women <br />10. Patients with history of abdominal surgery <br />11. Patients with American Society of Anesthesiologists'(ASA) physical status classification IV <br />12. Patients who do not consent to clinical trial <br />13. Patients incapable of reading, understanding, and signing a written consent form (e.g. mentally retarded, blinded, illiterate, foreigners, etc.) <br />14. Inmates of a prison or institution/hospital  
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Time of first passing flatus after operation 
Timepoint After operation 
Secondary Outcome(s) 1 
Outcome Postoperative pain score 
Timepoint After operation, three times a day 
Secondary Outcome(s) 2 
Outcome Bowel sound per minute 
Timepoint After operation, three times a day 
Secondary Outcome(s) 3 
Outcome Postoperative nausea and/or vomiting 
Timepoint After operation, daily 
Secondary Outcome(s) 4 
Outcome Time to tolerable water drinking and solid diet after operation 
Timepoint After operation 
Secondary Outcome(s) 5 
Outcome Postoperative analgesics 
Timepoint After operation, daily 
Secondary Outcome(s) 6 
Outcome Postoperative complications 
Timepoint After operation, daily 
Secondary Outcome(s) 7 
Outcome Readmission rate due to postoperative complications 
Timepoint After discharge, within 30 days 
Secondary Outcome(s) 8 
Outcome Time to mobilization(self walking) and self support to preoperative level 
Timepoint After operation, daily 
Secondary Outcome(s) 9 
Outcome Postoperative quality of life questionnaire 
Timepoint First OPD follow up day after discharge 
Secondary Outcome(s) 10 
Outcome Postoperative hospital stay 
Timepoint At discharge 
Secondary Outcome(s) 11 
Outcome Total cost during hospital stay after operation 
Timepoint After discharge 
Secondary Outcome(s) 12 
Outcome Protocol failure rate 
Timepoint During hospital stay 

11. Study Results and Publication

Study Results and Publication Information
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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