PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822506
• Other study ID #: 2019XZZX-ZJ0011
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2023
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Ke Wang, PhD
• Phone: 021-65161782
• Email: wangke8430[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
China	Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first flatus (TFF)	time to first flatus	Day 3
Secondary	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
Secondary	Time of first postoperative defecation	Patients self-report their defecation and doctors record the time	Day 3
Secondary	Dietary recovery	First time of water intake, tolerance to liquid diet time, tolerance to solid diet time	Day 3
Secondary	Postoperative gastrointestinal dysfunction	Duration and frequency of postoperative appearance: nausea, emesis,ventosity	Day 3
Secondary	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"
Secondary	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"
Secondary	Postperation pain	VAS,Visual analogy score (0 to 10,higher scores mean a worse outcome)	Day 3
Secondary	Motor function	Walking independently after surgery	Day 3
Secondary	LOS(length of stay)	From admission to discharge	Day 7
Secondary	Biochemical indexes	C-reactive protein(CRP),motilin(MTL).Gastrin(GAS),vasoactive peptide(VIP)	"Day 0","Day 3"
Secondary	Biochemical indexes 1	C-reactive protein(CRP, ug/L)	"Day 0","Day 3"
Secondary	Biochemical indexes 2	Motilin(MTL, ng/L)	"Day 0","Day 3"
Secondary	Biochemical indexes 3	Gastrin(GAS, ng/L)	"Day 0","Day 3"
Secondary	Biochemical indexes 4	vasoactive peptide(VIP, pg/L)	"Day 0","Day 3"
Secondary	Adverse Event Assessment	Any adverse events in the study	"Day 0","Day 3","Day 7"