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PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04822506
Enrollment
30
Registered
2021-03-30
Start date
2021-07-31
Completion date
2023-10-31
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

electroacupuncture, ERAS, Gastrointesinal function

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

Interventions

PROCEDURERoutine 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)

PROCEDURERoutine 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)

Sponsors

Shanghai Yueyang Integrated Medicine Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
time to first flatus (TFF)Day 3time to first flatus

Secondary

MeasureTime frameDescription
Biochemical indexesDay 0,Day 3C-reactive protein(CRP),motilin(MTL).Gastrin(GAS),vasoactive peptide(VIP)
Biochemical indexes 1Day 0,Day 3C-reactive protein(CRP, ug/L)
Biochemical indexes 2Day 0,Day 3Motilin(MTL, ng/L)
Postperation painDay 3VAS,Visual analogy score (0 to 10,higher scores mean a worse outcome)
Recovery time of postoperative bowel soundsDay 3The 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 defecationDay 3Patients self-report their defecation and doctors record the time
Dietary recoveryDay 3First time of water intake, tolerance to liquid diet time, tolerance to solid diet time
LOS(length of stay)Day 7From admission to discharge
Quality of life scale 1Day 0,Day 3,Day 7EORTC 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 2Day 0,Day 3,Day 7SF-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)
Motor functionDay 3Walking independently after surgery
Biochemical indexes 3Day 0,Day 3Gastrin(GAS, ng/L)
Biochemical indexes 4Day 0,Day 3vasoactive peptide(VIP, pg/L)
Adverse Event AssessmentDay 0,Day 3,Day 7Any adverse events in the study
Postoperative gastrointestinal dysfunctionDay 3Duration and frequency of postoperative appearance: nausea, emesis,ventosity

Countries

China

Contacts

Primary ContactKe Wang, PhD
wangke8430@163.com021-65161782
Backup ContactXuqiang Wei, PhD
wxqzdyx123@163.com15871123824

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026