Trial Title:
Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery
NCT ID:
NCT06128785
Condition:
Colorectal Cancer
Gastrointestinal Dysfunction
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal Cancer
Gastrointestinal Dysfunction
Enhanced Recovery After Surgery
Electroacupuncture
Randomized Controlled Trial
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Needles: Huatuo brand disposable acupuncture needles φ0.25×40mm (1.5 inch); needles are
purchased from Suzhou Medical Supplies Factory Co.
Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), lasting
30 min each time.
Postoperative electroacupuncture stimulation method: all acupoints will be taken by
tonifying method after obtaining qi, and unilaterally connected to the 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 will be 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
discharge or until the fourth day.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Both groups will use adhesive pads, and the 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.
All study patients will be treated independently and separately, ensuring that patients
will not come into contact with each other. To test the effectiveness of blinding of
participants, two hospitals will be selected from for blinded success assessment.
Intervention:
Intervention type:
Device
Intervention name:
Electroacupuncture group
Description:
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.
Arm group label:
Electroacupuncture group
Other name:
experimental group
Intervention type:
Other
Intervention name:
Sham EA group
Description:
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.
Arm group label:
Sham EA group
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.
Detailed description:
Colorectal cancer is the most common and predominant malignancy, and radical resection
surgery, as the main method of current treatment for colon and gastrointestinal cancers,
is performed on a large number of patients each year. Clinically, abdominal surgery
causes the highest frequency of gastrointestinal dysfunction and the longest relative
duration of dysfunction. A condition in which gastrointestinal function has not fully
recovered after abdominal surgery is called gastrointestinal dysfunction. The common
symptoms of postoperative gastrointestinal dysmotility are abdominal distension,
abdominal pain, nausea and vomiting, diminished or even absent bowel sounds, loss of anal
discharge, loss of bowel movements, and even secondary symptoms such as fever and
pulmonary infection. It will adversely affect patients' postoperative quality of life to
varying degrees, weaken their gastrointestinal barrier capacity, and severe
gastrointestinal dysfunction can lead to complications such as electrolyte disorders,
intestinal adhesions, intestinal obstruction, anastomotic fistula, and abdominal wall
incision dehiscence in patients, as well as increase the social burden and the economic
burden of patients. Some clinical reports show that acupuncture has good efficacy on
gastrointestinal dysfunction, and acupuncture has effects on the gastrointestinal tract
such as promoting gastrointestinal motility and reducing the inflammatory response of the
gastrointestinal tract. In this study, a multicenter, randomized, blinded, sham
acupuncture-controlled clinical design will be used to verify the efficacy of
postoperative electroacupuncture in accelerating the recovery of gastrointestinal
function after colorectal cancer surgery.
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. In other words, the
electroacupuncture instrument show the state of being connected, but it is not actually
energized; the acupuncture points, acupuncture time points, frequency, retention time and
treatment duration were the same as those of the intervention group.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Surgical patients who meet the diagnostic criteria for colorectal cancer and require
elective radical colorectal cancer surgery;
2. 18 years old ≤ age ≤ 79 years old, with no restriction on gender;
3. Understand, agree to participate in this study and sign the informed consent form;
4. American society of Aneshesiologists (ASA) classification I to III.
Exclusion Criteria:
1. Patients with psychiatric disorders;
2. Patients who have participated or are participating in other clinical studies in the
3 months prior to enrollment;
3. Patients with severe malnutrition (NRS2002 score ≥ 3);
4. Patients with total colectomy;
5. Patients undergoing ileal diversion for rectal cancer;
6. Patients with tumor infiltration requiring resection of other organs;
7. Prophylactic fistulae.
Anyone who meets any of the above criteria will be excluded from the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Yueyang Integrated Medicine Hospital
Address:
City:
Shanghai
Country:
China
Start date:
November 6, 2023
Completion date:
January 30, 2025
Lead sponsor:
Agency:
Shanghai Yueyang Integrated Medicine Hospital
Agency class:
Other
Collaborator:
Agency:
ShuGuang Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Shanghai Baoshan hospital of Integrated Traditional Chinese and Western Medicine
Agency class:
Other
Source:
Shanghai Yueyang Integrated Medicine Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06128785
