Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEA | Experimental |
| |
| sham-TEA | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Flatus | Defined as the period from the end of the surgery to the time of first flatus (hours). | Assessed up to 10 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged post operative ileus (PPOI) | defined as no flatus for more than 72 hours | Assessed up to 72 hours after surgery |
| time to first defecation | Defined as the period from the end of the surgery to the time of first defecation (hours). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Yu | Contact | 86006663 | xinxin_yu@zju.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
| Assessed up to 10 days after surgery |
| time to first water intake | The time from the end of the surgery to the first water intake (hours) | Assessed up to 10 days after surgery |
| 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. | Assessed up to 10 days after surgery |
| Time to tolerance of semi-liquid diet | "Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after semi-liquid food. Record the time ( hours) from the end of the surgery to the first tolerance of semi-liquid food. | Assessed up to 10 days after surgery |
| Time to tolerance of solid food | "Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after solid food. Record the time (hours) from the end of the surgery to the first tolerance of solid food. | Assessed up to 10 days after surgery |
| Time to first ambulation | The time from the end of the surgery to the first ambulation (hours). | Assessed up to 10 days after surgery |
| Postoperative nausea | The number and frequency of postoperative nausea episodes | At 24, 48, and 72 hours after surgery |
| postoperative vomiting | The number and frequency of postoperative vomiting | At 24, 48, and 72 hours after surgery |
| postoperative abdominal distension | The number and frequency of postoperative abdominal distension | At 24, 48, and 72 hours after surgery |
| Use of anti-emetic drugs after surgery | Number of participants using antiemetic drugs | At 24, 48, and 72 hours after surgery |
| Severity of postoperative pain | The assessment was conducted using a numerical rating scale (NRS). The scoring range was 0-10 (0 indicated no pain, while 10 indicated unbearable severe pain. Scores of 1-3 indicated mild pain that could be tolerated; 4-6 indicated pain that affected sleep but was still tolerable; 7-10 indicated severe pain that affected appetite and sleep). | At 24, 48, and 72 hours after surgery |
| Use of opioids drugs after surgery | The total dosage of all opioid analgesics used within 24 hours, 48 hours, and 72 hours after surgery, converted into morphine equivalents. | At 24, 48, and 72 hours after surgery |
| Postoperative quality of recovery | Assessed using the Quality of Recovery - 15 score (QoR-15) questionnaire preoperatively and daily. The total score ranges from 0 to 150 points. The higher the score, the better the post-anesthesia recovery quality. | baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first) |
| TEA Security | assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies) | Assessed up to 3 days after surgery |
| Postoperative complications | The severity of complications was evaluated using the Clavien-Dindo classification system (grades I to V), with Clavien-Dindo grade ≥ III complications serving as the major surgical complications. | From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery) |
| Total length of hospital stay | primary admission plus any readmission up to 30 days | Assessed up to 30 days after surgery |
| Unplanned readmission | Record the number of unplanned re-admissions within 30 days of hospital discharge | Assessed up to 30 days after surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |