PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Routine perioperative management and PEA; Procedure: Routine perioperative management and postEA

• Registration Number: NCT04822506
• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital

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"

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-03-30
• Study Start: 2021-07-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-07-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine perioperative management and PEA	Routine perioperative management and PEA	Routine perioperative management and perioperative electroacupuncture (preoperative, intraoperative, postoperative)；
Routine perioperative management and postEA	Routine perioperative management and postEA	Routine perioperative management and postoperative electroacupuncture

Primary Outcome Measures

Name	Time	Method
time to first flatus (TFF)	Day 3	time to first flatus

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China