Clinical trial NCT06128785: Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery
Official title: Electroacupuncture Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery: a Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Gastrointestinal Dysfunction
Keywords: Colorectal Cancer
Gastrointestinal Dysfunction
Enhanced Recovery After Surgery
Electroacupuncture
Randomized Controlled Trial
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: ShuGuang Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Baoshan hospital of Integrated Traditional Chinese and Western Medicine
First posted: 2023-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: Time of first postoperative exhaust
timeFrame: up to 4 days after surgery.
Secondary outcomes:
measure: Time of first postoperative defecation
timeFrame: up to 4 days after surgery.
measure: Length of recovery of bowel sounds after surgery ( Yueyang Hospital records only)
timeFrame: up to 4 days after surgery.
measure: Time of first postoperative intake of water
timeFrame: up to 4 days after surgery.
measure: Number of Postoperative nausea and vomiting episods
timeFrame: up to 4 days after surgery.
measure: Quality of life scale 1
timeFrame: baseline, discharge 1 day, 1 month after surgery.
measure: Quality of life scale 2
timeFrame: baseline, discharge 1 day, 1 month after surgery.
measure: Visual Analog Scale (VAS) of Pain
timeFrame: up to 4 days after surgery.
measure: Postoperative hospitalization days
timeFrame: up to 4 days
measure: Biochemical indexes 1
timeFrame: 1 hour postoperatively, 12 hours postoperatively, 72 hours postoperatively.
measure: Biochemical indexes 2
timeFrame: 1 hour postoperatively, 12 hours postoperatively, 72 hours postoperatively.
measure: Biochemical indexes 3
timeFrame: baseline, discharge 1 day.
Other outcomes:
measure: Adverse Event Assessment
timeFrame: up to 4 days
Locations:
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Yueyang Integrated Medicine Hospital
name: Jia Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References: