PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Routine perioperative management and PEA
Routine perioperative management and postEA
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring electroacupuncture, ERAS, Gastrointesinal function
Eligibility Criteria
Inclusion Criteria:
- Patients who meet the diagnostic criteria of colorectal cancer and need elective radical resection of colorectal cancer;
- 18≤ 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;
Exclusion Criteria:
- 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.
Sites / Locations
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Routine perioperative management and PEA
Routine perioperative management and postEA
Arm Description
Routine perioperative management and perioperative electroacupuncture (preoperative, intraoperative, postoperative);
Routine perioperative management and postoperative electroacupuncture
Outcomes
Primary Outcome Measures
time to first flatus (TFF)
time to first flatus
Secondary Outcome Measures
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
Time of first postoperative defecation
Patients self-report their defecation and doctors record the time
Dietary recovery
First time of water intake, tolerance to liquid diet time, tolerance to solid diet time
Postoperative gastrointestinal dysfunction
Duration and frequency of postoperative appearance: nausea, emesis,ventosity
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);
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)
Postperation pain
VAS,Visual analogy score (0 to 10,higher scores mean a worse outcome)
Motor function
Walking independently after surgery
LOS(length of stay)
From admission to discharge
Biochemical indexes
C-reactive protein(CRP),motilin(MTL).Gastrin(GAS),vasoactive peptide(VIP)
Biochemical indexes 1
C-reactive protein(CRP, ug/L)
Biochemical indexes 2
Motilin(MTL, ng/L)
Biochemical indexes 3
Gastrin(GAS, ng/L)
Biochemical indexes 4
vasoactive peptide(VIP, pg/L)
Adverse Event Assessment
Any adverse events in the study
Full Information
NCT ID
NCT04822506
First Posted
February 23, 2021
Last Updated
January 8, 2023
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04822506
Brief Title
PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation
Official Title
Perioperative Electroacupuncture Promotes Early Gastrointestinal Function Rehabilitation After Radical Resection of Colorectal Cancer: a Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yueyang Integrated Medicine Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
electroacupuncture, ERAS, Gastrointesinal function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine perioperative management and PEA
Arm Type
Experimental
Arm Description
Routine perioperative management and perioperative electroacupuncture (preoperative, intraoperative, postoperative);
Arm Title
Routine perioperative management and postEA
Arm Type
Active Comparator
Arm Description
Routine perioperative management and postoperative electroacupuncture
Intervention Type
Procedure
Intervention Name(s)
Routine perioperative management and PEA
Intervention Description
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
Intervention Name(s)
Routine perioperative management and postEA
Intervention Description
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)
Primary Outcome Measure Information:
Title
time to first flatus (TFF)
Description
time to first flatus
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Recovery time of postoperative bowel sounds
Description
The enteric voice continuous auscultation recorder was used to monitor immediately after operation, and the time to the end of operation was calculated
Time Frame
Day 3
Title
Time of first postoperative defecation
Description
Patients self-report their defecation and doctors record the time
Time Frame
Day 3
Title
Dietary recovery
Description
First time of water intake, tolerance to liquid diet time, tolerance to solid diet time
Time Frame
Day 3
Title
Postoperative gastrointestinal dysfunction
Description
Duration and frequency of postoperative appearance: nausea, emesis,ventosity
Time Frame
Day 3
Title
Quality of life scale 1
Description
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);
Time Frame
"Day 0","Day 3","Day 7"
Title
Quality of life scale 2
Description
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)
Time Frame
"Day 0","Day 3","Day 7"
Title
Postperation pain
Description
VAS,Visual analogy score (0 to 10,higher scores mean a worse outcome)
Time Frame
Day 3
Title
Motor function
Description
Walking independently after surgery
Time Frame
Day 3
Title
LOS(length of stay)
Description
From admission to discharge
Time Frame
Day 7
Title
Biochemical indexes
Description
C-reactive protein(CRP),motilin(MTL).Gastrin(GAS),vasoactive peptide(VIP)
Time Frame
"Day 0","Day 3"
Title
Biochemical indexes 1
Description
C-reactive protein(CRP, ug/L)
Time Frame
"Day 0","Day 3"
Title
Biochemical indexes 2
Description
Motilin(MTL, ng/L)
Time Frame
"Day 0","Day 3"
Title
Biochemical indexes 3
Description
Gastrin(GAS, ng/L)
Time Frame
"Day 0","Day 3"
Title
Biochemical indexes 4
Description
vasoactive peptide(VIP, pg/L)
Time Frame
"Day 0","Day 3"
Title
Adverse Event Assessment
Description
Any adverse events in the study
Time Frame
"Day 0","Day 3","Day 7"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who meet the diagnostic criteria of colorectal cancer and need elective radical resection of colorectal cancer;
18≤ 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;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke Wang, PhD
Phone
021-65161782
Ext
+86
Email
wangke8430@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuqiang Wei, PhD
Phone
15871123824
Ext
+86
Email
wxqzdyx123@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Zhou, MD
Organizational Affiliation
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM
Official's Role
Study Director
Facility Information:
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Zhou, M.D.
Email
pdzhoujia@163.com
First Name & Middle Initial & Last Name & Degree
Ke Wang, Ph D
Email
wangke8430@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Through the article publication
IPD Sharing Time Frame
6 month later for one year
IPD Sharing Access Criteria
contact with the principal investigator
Learn more about this trial
PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation
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