PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation

NCT ID: NCT04822506

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2023-10-31

Brief Summary

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

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"

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Routine perioperative management and PEA

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

Group Type: EXPERIMENTAL

Routine perioperative management and PEA

Intervention Type: 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 postEA

Routine perioperative management and postoperative electroacupuncture

Group Type: ACTIVE_COMPARATOR

Routine perioperative management and postEA

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Zhou, MD

Role: STUDY_DIRECTOR

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

Locations

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

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ke Wang, PhD

Role: CONTACT

wangke8430@163.com

021-65161782 ext. +86

Xuqiang Wei, PhD

Role: CONTACT

wxqzdyx123@163.com

15871123824 ext. +86

Facility Contacts

Jia Zhou, M.D.

Role: primary

pdzhoujia@163.com

Ke Wang, Ph D

Role: backup

wangke8430@163.com

Other Identifiers

2019XZZX-ZJ0011

Identifier Type: -

Identifier Source: org_study_id