Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery
NCT06128785 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2023-11-13
Summary
The goal of this clinical trial is to verify the efficacy of electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery. The main questions it aims to answer are:
* Whether electroacupuncture can accelerate the recovery of gastrointestinal function in patients after colorectal cancer surgery.
* Whether electroacupuncture intervention is safe for postoperative colorectal cancer patients.
Participants will be randomized into 3 groups:
The conventional control group will receive postoperative rehydration and nutritional support, correction of acid-base imbalance and electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatments.
In the electroacupuncture group, acupuncture will be performed within 6 hours after surgery on the basis of the conventional control group. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). Both after obtaining Qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation, the current frequency is continuous wave 5 Hz, the intensity of stimulation was as the patient tolerated, each time lasting 30 min. Acupuncture stimulation was given every 12 h. The course of treatment was terminated postoperatively until the fourth postoperative day (d0-d4) or until the patient showed the first postoperative anal exhaust or continued until the fourth day.
The sham acupuncture group will based on the conventional control group, using a blunt-tipped needle tip that do not pierce the adhesive pad.
Conditions
- Colorectal Cancer
- Gastrointestinal Dysfunction
Interventions
- DEVICE
-
Electroacupuncture group
Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation was given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal exhaust or until the fourth day.
- OTHER
-
Sham EA group
Sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output.
Sponsors & Collaborators
-
ShuGuang Hospital
collaborator OTHER -
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Shanghai Baoshan hospital of Integrated Traditional Chinese and Western Medicine
collaborator UNKNOWN -
Shanghai Yueyang Integrated Medicine Hospital
lead OTHER
Principal Investigators
-
Jia Zhou, M.D. · Shanghai Yueyang Integrated Medicine Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-06
- Primary Completion
- 2025-01-30
- Completion
- 2025-01-30
Countries
- China
Study Locations
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