Clinical trial NCT04822506: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: electroacupuncture
ERAS
Gastrointesinal function
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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"

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.

Primary outcomes:
measure: time to first flatus (TFF)
timeFrame: Day 3
Secondary outcomes:
measure: Recovery time of postoperative bowel sounds
timeFrame: Day 3
measure: Time of first postoperative defecation
timeFrame: Day 3
measure: Dietary recovery
timeFrame: Day 3
measure: Postoperative gastrointestinal dysfunction
timeFrame: Day 3
measure: Quality of life scale 1
timeFrame: "Day 0"，"Day 3"，"Day 7"
measure: Quality of life scale 2
timeFrame: "Day 0"，"Day 3"，"Day 7"
measure: Postperation pain
timeFrame: Day 3
measure: Motor function
timeFrame: Day 3
measure: LOS(length of stay)
timeFrame: Day 7
measure: Biochemical indexes
timeFrame: "Day 0"，"Day 3"
measure: Biochemical indexes 1
timeFrame: "Day 0"，"Day 3"
measure: Biochemical indexes 2
timeFrame: "Day 0"，"Day 3"
measure: Biochemical indexes 3
timeFrame: "Day 0"，"Day 3"
measure: Biochemical indexes 4
timeFrame: "Day 0"，"Day 3"
measure: Adverse Event Assessment
timeFrame: "Day 0"，"Day 3"，"Day 7"
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM
name: Jia Zhou, MD
role: STUDY_DIRECTOR
References: