Effect of buccal acupuncture therapy on postoperative gastrointestinal function in patients undergoing colorectal surgery
| ISRCTN | ISRCTN79031980 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79031980 |
| Secondary identifying numbers | Applied Basic Research Project of Changzhou Science and Technology Bureau (CJ20220098) |
- Submission date
- 02/09/2024
- Registration date
- 28/09/2024
- Last edited
- 04/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Despite optimized Enhanced Recovery After Surgery (ERAS) protocols, postoperative gastrointestinal dysfunction remains a major clinical challenge for patients undergoing colorectal cancer surgery. This study aims to promote postoperative gastrointestinal function recovery in patients with colorectal cancer through buccal acupuncture therapy to improve the prevention and treatment of postoperative gastrointestinal dysfunction, reduce the incidence of postoperative gastrointestinal dysfunction, promote rapid recovery of patients, and reduce medical costs.
Who can participate?
Patients aged between 18 and 80 years old undergoing elective radical colorectal cancer surgery
What does the study involve?
Patients will be randomly assigned to a buccal acupuncture group and a control group. Patients in the buccal acupuncture group will receive buccal acupuncture treatment 30 minutes before surgery and 30 minutes after awakening, with needles retained for 20 minutes each time. The control group patients will receive conventional treatment without cheek acupuncture intervention. All patients will receive standardized anesthesia management and Enhanced Recovery After Surgery (ERAS) protocols and patient-controlled intravenous postoperative pain management. The primary outcome is to assess the time to first defecation, with secondary outcomes assessing the time to first flatus, the time to first tolerated liquid diet, the time to first tolerated semi-liquid diet, postoperative pain, levels of motilin and gastrin, and quality of life.
What are the possible benefits and risks of participating?
Benefits: The protocol for this clinical study has been reviewed by the Medical Ethics Committee of the participating hospital to maximize the protection of participants' rights and interests and ensure scientific validity. Buccal acupuncture not only helps regulate the qi and blood of the triple energizer, promoting the smooth flow of vital energy in the internal organs to improve gastrointestinal function, but also better controls pain, reduces perioperative stress response, and decreases the use of general anesthesia and analgesic medications. With its proven effectiveness and absence of toxic side effects, buccal acupuncture is gradually becoming an important complementary strategy for the comprehensive prevention and treatment of postoperative ileus (POI). This procedure has significant advantages, including being safe, painless, and effective, making it a cost-efficient new approach that integrates Traditional Chinese Medicine (TCM) and Western medicine.
Risks: Buccal acupuncture does not cause severe structural damage and has minimal risk of bleeding or hematoma at the puncture site, which can usually be stopped with simple pressure. Researchers will closely monitor participants throughout the study, and in the event of any adverse or serious adverse events, timely measures will be taken to manage the situation appropriately.
Where is the study run from?
Changzhou First People's Hospital
When is the study starting and how long is it expected to run for?
June 2024 to June 2027
Who is funding the study?
Applied Basic Research Project of Changzhou Science and Technology Bureau
Who is the main contact?
Mrs Yang Ping, yp364394838@163.com
Contact information
Scientific
168 Honghe Road, Xinbei District
Changzhou City, Jiangsu Province
213000
China
| Phone | 86+ 13861247672 |
|---|---|
| yp364394838@163.com |
Principal Investigator
The First People's Hospital of Changzhou, 185 Guqian Street, Tianning District
Changzhou City, Jiangsu Province
213000
China
| Phone | +86 13915089989 |
|---|---|
| qiulanmz@163.com |
Public
The First People's Hospital of Changzhou, 185 Guqian Street, Tianning District
Changzhou City, Jiangsu Province
213000
China
| Phone | 86+ 13806123631 |
|---|---|
| 2251594829@qq.com |
Study information
| Study design | Single-center single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Prevention, Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A randomized controlled trial to evaluate the efficacy of buccal acupuncture in the recovery of gastrointestinal function after colorectal cancer surgery |
| Study acronym | BAR-GIC Trial |
| Study objectives | Buccal acupuncture therapy under the Enhanced Recovery After Surgery (ERAS) pathway can further accelerate the recovery of gastrointestinal function in patients undergoing laparoscopic colorectal cancer surgery |
| Ethics approval(s) |
Approved 03/06/2024, Changzhou First People's Hospital Ethics Committee (185 Guqian Street, Tianning District, Changzhou City, Jiangsu Province, 213000, China; +86 519 6887 0965; czyyirb@163.com), ref: (2024) Teaching No. 029 |
| Health condition(s) or problem(s) studied | Prevention and treatment of postoperative gastrointestinal dysfunction in patients with colorectal cancer |
| Intervention | This study is a randomized, single-blind, controlled trial involving patients undergoing elective radical colorectal cancer surgery. Participants will be randomly assigned to either the buccal acupuncture group or the control group. Randomisation will be conducted using a computer-generated random number table to ensure allocation concealment. All patients will receive standardized anesthesia and Enhanced Recovery After Surgery (ERAS) management strategies. The buccal acupuncture group will receive cheek acupuncture treatment 30 minutes before surgery and 30 minutes after awakening, with needles retained for 20 minutes each time. The control group will receive conventional treatment. Postoperative analgesia will be provided with patient-controlled intravenous analgesia (PCIA) in both groups. The study aims to explore the effectiveness and safety of buccal acupuncture therapy in promoting the recovery of gastrointestinal function in patients after colorectal cancer surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to first defecation measured using patient self-report from the end of surgery to the first occurrence of bowel movement |
| Secondary outcome measures | 1. Time to first flatus measured using patient self-report from the end of surgery to the first passage of gas 2. Time to first tolerate a liquid diet measured using patient self-report from the end of surgery to the first successful intake of a liquid diet without gastrointestinal intolerance 3. Time to first tolerate a semi-liquid diet, measured using patient self-report from the end of surgery to the first successful intake of a semi-liquid diet without gastrointestinal intolerance 4. Postoperative ileus measured using the I-FEED score on postoperative day 4 5. Postoperative pain score measured using the Visual Analog Scale (VAS) at 30 minutes after awakening, 24 hours postoperatively, and 48 hours postoperatively 6. Motilin and gastrin levels measured using the enzyme-linked immunosorbent assay (ELISA) at 30 minutes before surgery, 30 minutes after awakening, and 24 hours postoperatively 7. Quality of life measured using the EORTC QLG Core Questionnaire (EORTC QLQ-C30) at baseline and 30 days postoperatively |
| Overall study start date | 01/06/2024 |
| Completion date | 01/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 94 |
| Key inclusion criteria | 1. Age 18-80 years old, no gender restrictions 2. Body mass index (BMI) ≤40 kg/m2 3. American College of Anesthesiologists (ASA) grade I to III 4. Radical resection of colorectal cancer should be performed at the selected time |
| Key exclusion criteria | 1. Long-term use of opioids, psychotropic drugs, non-steroidal drugs, etc 2. A history of alcoholism and/or mental illness 3. Tumor recurrence 4. There is an infection in the cheek, or the coagulation function is abnormal 5. Have trigeminal neuralgia or facial paralysis 6. An enterostomy is required |
| Date of first enrolment | 06/06/2024 |
| Date of final enrolment | 01/06/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Changzhou City, Jiangsu Province
213000
China
Sponsor information
Government
185 Juqian Street, Tianning District
Changzhou City, Jiangsu Province
213000
China
| Phone | 86+ 0519 68870312 |
|---|---|
| yykjk80814@163.com | |
| Website | http://www.czfph.com/ |
"ROR" |
https://ror.org/00wgk5w17 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- 常州市科技局, CZST
- Location
- China
Results and Publications
| Intention to publish date | 01/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
04/09/2024: Study's existence confirmed by the Changzhou First People's Hospital Ethics Committee.
