PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation

NCT04822506 | Unknown DMC

• 1 other identifier: 2019XZZX-ZJ0011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

electroacupuncture; ERAS; Gastrointesinal function

Outcome Measures

Primary Outcomes (1)

• time to first flatus (TFF)

  time to first flatus

  Day 3

Secondary Outcomes (15)

• Recovery time of postoperative bowel sounds

  Day 3

• Time of first postoperative defecation

  Day 3

• Dietary recovery

  Day 3

• Postoperative gastrointestinal dysfunction

  Day 3

• Quality of life scale 1

  "Day 0"，"Day 3"，"Day 7"

Study Arms (2)

Routine perioperative management and PEA

EXPERIMENTAL

Routine perioperative management and perioperative electroacupuncture (preoperative, intraoperative, postoperative)；

Procedure: Routine perioperative management and PEA

Routine perioperative management and postEA

ACTIVE COMPARATOR

Routine perioperative management and postoperative electroacupuncture

Procedure: Routine perioperative management and postEA

Interventions

Routine perioperative management and PEA PROCEDURE

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)

Routine perioperative management and PEA

Routine perioperative management and postEA PROCEDURE

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)

Routine perioperative management and postEA

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

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

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jia Zhou, MD

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

  STUDY DIRECTOR

Central Study Contacts

Ke Wang, PhD

CONTACT

021-65161782; wangke8430@163.com

Xuqiang Wei, PhD

CONTACT

15871123824; wxqzdyx123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 30, 2021
• Study Start: July 31, 2021
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 month later for one year
• Access Criteria: contact with the principal investigator

Locations

CN (1)