PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation

Perioperative Electroacupuncture Promotes Early Gastrointestinal Function Rehabilitation After Radical Resection of Colorectal Cancer: a Pilot Trial

To investigate whether perioperative electroacupuncture is more effective than postoperative electroacupuncture in improving gastrointestinal function after colorectal cancer operation

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Routine perioperative management and PEA; Procedure: Routine perioperative management and postEA

Detailed Description

Although there are large intestine cancer postoperative clinical research of acupuncture, but fewer sample size, whether perioperative acupuncture intervention is superior to the postoperative acupuncture intervention, remains to be seen, so investigators proposed to carry out the preliminary experiment, the data can be collected according to the different characteristics of perioperative, perioperative choose different acupoints compatibility, give full play to the needle medicine compound anesthesia in colorectal cancer surgery play a unique function of viscera protection, to explore the curative in colorectal cancer surgery perioperative intervened to promote the role of gastrointestinal function after surgery for early rehabilitation provides evidence-based medical evidence, develop and optimize the acupuncture and drugs combined anesthesia in colorectal cancer surgery perioperative application of specification, It promoted the establishment of the first treatment mode of "accelerated recovery in perioperative period of colorectal cancer operation based on combined acupuncture and drug anesthesia"

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke Wang, PhD; Phone Number: +86 021-65161782; Email: wangke8430@163.com
• Study Contact Backup: Name: Xuqiang Wei, PhD; Phone Number: +86 15871123824; Email: wxqzdyx123@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
    • Contact: Jia Zhou, M.D.; Email: pdzhoujia@163.com
    • Contact: Ke Wang, Ph D; Email: wangke8430@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who meet the diagnostic criteria of colorectal cancer and need elective radical resection of colorectal cancer;
2. 18≤ age≤79, gender is not limited;
3. Understand and agree to participate in the study and sign the informed consent;
4. No previous history of abdominal surgery and no abdominal adhesion;

Exclusion Criteria:

1. Patients with mental illness;
2. Patients requiring combined resection of other organs;
3. Participated in or is participating in other clinical researchers in the previous 3 months
4. People who have received acupuncture (including electroacupuncture) in the past;
5. Other treatment options are being used (chemotherapy, radiotherapy, etc.) Those who meet any of the above criteria will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Routine perioperative management and PEA; Routine perioperative management and perioperative electroacupuncture (preoperative, intraoperative, postoperative)；	Procedure: Routine perioperative management and PEA; Routine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Preoperation:RN 6 + RN 4 +ST30 + ST 36+ Hegu (bilateral),De qi, electroacupuncture, continuous wave, 5Hz, 30min before surgery at 19:00 PM Inoperatively: LI 4+ PC 6 + ST36 + GB 34 (bilateral) ,Deqi, electroacupuncture with density wave, 2/100Hz, 30 minutes before operation to the end of the operation Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF)
Active Comparator: Routine perioperative management and postEA; Routine perioperative management and postoperative electroacupuncture	Procedure: Routine perioperative management and postEA; Routine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first flatus (TFF)	time to first flatus	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time of postoperative bowel sounds	The enteric voice continuous auscultation recorder was used to monitor immediately after operation, and the time to the end of operation was calculated	Day 3
Time of first postoperative defecation	Patients self-report their defecation and doctors record the time	Day 3
Dietary recovery	First time of water intake, tolerance to liquid diet time, tolerance to solid diet time	Day 3
Postoperative gastrointestinal dysfunction	Duration and frequency of postoperative appearance: nausea, emesis,ventosity	Day 3
Quality of life scale 1	EORTC QLQ-C30（Version 3.0 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (standard score, SS, range from 0 to 100, higher scores mean a better outcome);	"Day 0"，"Day 3"，"Day 7"
Quality of life scale 2	SF-36(Chinese version),The Short Form (36) Health Survey,( The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability)	"Day 0"，"Day 3"，"Day 7"
Postperation pain	VAS,Visual analogy score (0 to 10,higher scores mean a worse outcome)	Day 3
Motor function	Walking independently after surgery	Day 3
LOS(length of stay)	From admission to discharge	Day 7
Biochemical indexes	C-reactive protein(CRP)，motilin(MTL).Gastrin(GAS),vasoactive peptide(VIP)	"Day 0"，"Day 3"
Biochemical indexes 1	C-reactive protein(CRP, ug/L)	"Day 0"，"Day 3"
Biochemical indexes 2	Motilin(MTL, ng/L)	"Day 0"，"Day 3"
Biochemical indexes 3	Gastrin(GAS, ng/L)	"Day 0"，"Day 3"
Biochemical indexes 4	vasoactive peptide(VIP, pg/L)	"Day 0"，"Day 3"
Adverse Event Assessment	Any adverse events in the study	"Day 0"，"Day 3"，"Day 7"

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Investigators: Study Director: Jia Zhou, MD, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: electroacupuncture; ERAS; Gastrointesinal function
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2019XZZX-ZJ0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Through the article publication
• IPD Sharing Time Frame: 6 month later for one year
• IPD Sharing Access Criteria: contact with the principal investigator
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No