PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation

• ClinicalTrials.gov Identifier: NCT04822506
• Recruitment Status: Not yet recruiting
• First Posted: March 30, 2021
• Last Update Posted: March 30, 2021
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Information provided by (Responsible Party): Shanghai Yueyang Integrated Medicine Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Procedure: Routine perioperative management and PEA; Procedure: Routine perioperative management and postEA	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Perioperative Electroacupuncture Promotes Early Gastrointestinal Function Rehabilitation After Radical Resection of Colorectal Cancer: a Pilot Trial
• Estimated Study Start Date: March 30, 2021
• Estimated Primary Completion Date: December 18, 2021
• Estimated Study Completion Date: July 30, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. time to first flatus (TFF) [ Time Frame: Day 3 ]
   time to first flatus

Secondary Outcome Measures :

1. Recovery time of postoperative bowel sounds [ Time Frame: Day 3 ]
   The enteric voice continuous auscultation recorder was used to monitor immediately after operation, and the time to the end of operation was calculated
2. Time of first postoperative defecation [ Time Frame: Day 3 ]
   Patients self-report their defecation and doctors record the time
3. Dietary recovery [ Time Frame: Day 3 ]
   First time of water intake, tolerance to liquid diet time, tolerance to solid diet time
4. Postoperative gastrointestinal dysfunction [ Time Frame: Day 3 ]
   Duration and frequency of postoperative appearance: nausea, emesis,ventosity
5. Quality of life scale 1 [ Time Frame: "Day 0"，"Day 3"，"Day 7" ]
   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);
6. Quality of life scale 2 [ Time Frame: "Day 0"，"Day 3"，"Day 7" ]
   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)
7. Postperation pain [ Time Frame: Day 3 ]
   VAS,Visual analogy score (0 to 10,higher scores mean a worse outcome)
8. Motor function [ Time Frame: Day 3 ]
   Walking independently after surgery
9. LOS(length of stay) [ Time Frame: Day 7 ]
   From admission to discharge
10. Biochemical indexes [ Time Frame: "Day 0"，"Day 3" ]
    C-reactive protein(CRP)，motilin(MTL).Gastrin(GAS),vasoactive peptide(VIP)
11. Biochemical indexes 1 [ Time Frame: "Day 0"，"Day 3" ]
    C-reactive protein(CRP, ug/L)
12. Biochemical indexes 2 [ Time Frame: "Day 0"，"Day 3" ]
    Motilin(MTL, ng/L)
13. Biochemical indexes 3 [ Time Frame: "Day 0"，"Day 3" ]
    Gastrin(GAS, ng/L)
14. Biochemical indexes 4 [ Time Frame: "Day 0"，"Day 3" ]
    vasoactive peptide(VIP, pg/L)
15. Adverse Event Assessment [ Time Frame: "Day 0"，"Day 3"，"Day 7" ]
    Any adverse events in the study

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Ke Wang, PhD; 021-65161782 ext +86; wangke8430@163.com

Contact: Xuqiang Wei, PhD; 15871123824 ext +86; wxqzdyx123@163.com

Locations

China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, China

Sponsors and Collaborators

Shanghai Yueyang Integrated Medicine Hospital

Investigators

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

More Information

• Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
• ClinicalTrials.gov Identifier: NCT04822506
• Other Study ID Numbers: 2019XZZX-ZJ0011
• First Posted: March 30, 2021
• Last Update Posted: March 30, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Through the article publication
• Supporting Materials: Study Protocol
• Time Frame: 6 month later for one year
• Access Criteria: contact with the principal investigator

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:

electroacupuncture; ERAS; Gastrointesinal function

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases