Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery

NCT ID: NCT06128785

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2025-01-30

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.

Conditions

Colorectal Cancer; Gastrointestinal Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Electroacupuncture group

The acupuncture will be performed within 6 hours after surgery 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 discharge or until the fourth day.

Group Type: EXPERIMENTAL

Electroacupuncture group

Intervention Type: DEVICE

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.

Sham EA group

In order to achieve maximum patient blindness, 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, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output. All study patients will be treated independently and separately to ensure that patients will not come into contact with each other.

Group Type: SHAM_COMPARATOR

Sham EA group

Intervention Type: OTHER

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.

Conventional control group

Routine perioperative management will be given, postoperative fluid and nutritional support, correction of acid-base imbalance, electrolyte disorders, anti-infection, hemostasis and other symptomatic management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

experimental 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ShuGuang Hospital

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Baoshan hospital of Integrated Traditional Chinese and Western Medicine

UNKNOWN

Sponsor Role: collaborator

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Zhou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Yueyang Integrated Medicine Hospital

Locations

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Ke Wang

Role: CONTACT

wangke8430@163.com

+8618917235387

References

Sun L, Wei X, Feng T, Gu Q, Li J, Wang K, Zhou J. Electroacupuncture promotes gastrointestinal functional recovery after radical colorectal cancer surgery: a protocol of multicenter randomized controlled trial (CORRECT trial). Int J Colorectal Dis. 2024 Dec 9;39(1):198. doi: 10.1007/s00384-024-04768-8.

Reference Type: DERIVED

PMID: 39652211 (View on PubMed)

Other Identifiers

2023-144

Identifier Type: -

Identifier Source: org_study_id