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

NCT06128785 | Unknown DMC

• 1 other identifier: 2023-144
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Gastrointestinal Dysfunction

Keywords

Colorectal Cancer; Gastrointestinal Dysfunction; Enhanced Recovery After Surgery; Electroacupuncture; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Time of first postoperative exhaust

  The time between the patient's first exhaust and the end of surgery will be recorded.

  up to 4 days after surgery.

Secondary Outcomes (11)

• Time of first postoperative defecation

  up to 4 days after surgery.

• Length of recovery of bowel sounds after surgery ( Yueyang Hospital records only)

  up to 4 days after surgery.

• Time of first postoperative intake of water

  up to 4 days after surgery.

• Number of Postoperative nausea and vomiting episods

  up to 4 days after surgery.

• Quality of life scale 1

  baseline, discharge 1 day, 1 month after surgery.

Other Outcomes (1)

• Adverse Event Assessment

  up to 4 days

Study Arms (3)

Electroacupuncture group

EXPERIMENTAL

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.

Device: Electroacupuncture group

Sham EA group

SHAM COMPARATOR

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.

Other: Sham EA group

Conventional control group

NO INTERVENTION

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.

Interventions

Electroacupuncture group 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.

Also known as: experimental group

Electroacupuncture group

Sham EA group 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.

Sham EA group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical patients who meet the diagnostic criteria for colorectal cancer and require elective radical colorectal cancer surgery;
• years old ≤ age ≤ 79 years old, with no restriction on gender;
• Understand, agree to participate in this study and sign the informed consent form;
• American society of Aneshesiologists (ASA) classification I to III.

You may not qualify if:

• Patients with psychiatric disorders;
• Patients who have participated or are participating in other clinical studies in the 3 months prior to enrollment;
• Patients with severe malnutrition (NRS2002 score ≥ 3);
• Patients with total colectomy;
• Patients undergoing ileal diversion for rectal cancer;
• Patients with tumor infiltration requiring resection of other organs;
• Prophylactic fistulae.
• Anyone who meets any of the above criteria will be excluded from the study.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead
• ShuGuang Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Baoshan hospital of Integrated Traditional Chinese and Western Medicine: collaborator

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 39652211 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jia Zhou, M.D.

  Shanghai Yueyang Integrated Medicine Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Wang

CONTACT

+8618917235387; wangke8430@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: November 13, 2023
• Study Start: November 6, 2023
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Starting 12 months after publication.
• Access Criteria: For academic communication only, online supplementary documents and email communication can be added.

Locations

CN (1)