Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSir Run Run Shaw Hospital

About this trial

The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are:

Can TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery.

Participants will:

Starting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days.

Record the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 years old.

Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer.

American Society of Anesthesiologists classification (ASA) 1-4.

Able to understand the research process and the use of various assessment scales, and able to communicate effectively with the researchers.

Disqualifiers

Previous history of abdominal gastrointestinal surgery.

Planned for palliative or emergency surgery.

Planned for open abdominal surgery or creation of a new stoma.

Transfer to ICU.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TEA

    Device

    The subjects in the TEA group were placed in the supine position and received transcutaneous electrical acupoint stimulation at the bilateral PC6 and bilateral ST36 . After confirming the location of the acupoints , special skin treatment was carried out. The stimulation parameters for PC6 were set as follows: 0.1 seconds of opening stimulation, 0.4 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 100 Hz, and amplitude ranging from 1 to 10 mA (based on the maximum level that the subject could tolerate). The stimulation parameters for ST36 were set as follows: 2 seconds of opening stimulation, 3 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude ranging from 2 to 10 mA (based on the maximum level that the subject could tolerate).

  • sham-TEA

    Device

    Sham-TEA was the same except that non-acupoints were used to replace ST36 and PC6. The sham-acupoint for PC6 was located at about 15-20 cm away from PC6 (up to the elbow and outside of the coastal margin of the forearm not on any meridian) and the sham-point for ST36 was located at 10-15 cm down from and to the lateral side of ST36 not on any meridian

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: TEAExperimental treatment 1 intervention
Group B: sham-TEASham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to First Flatus

Defined as the period from the end of the surgery to the time of first flatus (hours).

Time frame
Assessed up to 10 days after surgery

Secondary outcomes

1

Prolonged post operative ileus (PPOI)

defined as no flatus for more than 72 hours

Time frame
Assessed up to 72 hours after surgery
2

time to first defecation

Defined as the period from the end of the surgery to the time of first defecation (hours).

Time frame
Assessed up to 10 days after surgery
3

time to first water intake

The time from the end of the surgery to the first water intake (hours)

Time frame
Assessed up to 10 days after surgery
4

Time to tolerance of liquid diet

"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after the liquid diet. Record the time (in hours) from the end of the surgery to the first tolerance to the liquid diet.

Time frame
Assessed up to 10 days after surgery

Other outcomes

Sponsors and contacts

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