Study setting
The study is a multicenter, randomized, controlled, single-blind, superiority trial (RCT) registered in the Chinese Clinical Registry on June 13, 2021. The registration number is ChiCTR2100047381. The trial centers are the First Affiliated Hospital of Jinan University in Guangzhou, Guangdong Province, China and Luoyang Hospital of traditional Chinese medicine in Luoyang City, Henan Province, China, and the study design and protocol manuscript followed CONSORT specifications.
Eligibility criteria
Inclusion criteria
•Age: between18 to 65 years of age.
•Female patients with a physical status of I or II according to the American Society of Anesthesiologists (ASA) classification criteria; and who have completed their first LSG procedure under general from October 2021 - April 2022.
•BMI ≥ 27.5.
Exclusion criteria
• Contraindications of AA, such as skin rash or local infection in the skin area stimulated by acupoints;
• History of chemotherapy within 4 weeks or radiotherapy within 8 weeks;
• Nausea and vomiting occurred 24 hours before the operation;
• Hormone use within 1 week;
• Abnormal liver and kidney function;
• Gastroesophageal reflux disease
• Investigator was unable to complete the study for other reasons;
• Those who regain weight after weight loss and metabolic surgery.
Who will take informed consent?
Written informed consent was obtained from potential participants who met the inclusion and exclusion criteria by a pre-trained researcher. The informed consent form was written in Chinese, explaining the study to the h person, asking whether the patient was willing to participate, and asking the patient to sign the informed consent form if they agreed.
Additional consent provisions for the collection and use of participant data and biological specimens
Prior trained study staff will explain this to participants simultaneously as they sign the informed consent form.
Interventions
Eligible participants will be divided into two groups, one for the control group and one for the experimental group. The control group was treated with conventional antiemetic drugs. The experimental group was based on conventional antiemetic drugs taking the three auricular acupoints "Shenmen(TF4), Stomach(CO4), occiput(AT3), Inferior cortex(AT4), Sympathetic nerve(AH6a), as the main acupoints and "Small intestine point(CO6) and Large intestine point(CO7)" as the supporting acupoints. After disinfection of the ear with a 75% alcohol cotton ball, the left hand fixed the auricle. The right hand held the vascular clamp and put the adhesive tape (0.8cm×0.8cm) with magnetic beads in the above ear points, and gave the patient pressure on the ear points within 24h before surgery and 48h after surgery, using the index finger and thumb to twist the pressure in front of and behind the ear, with light and heavy hand, pressing each point for 3~5min, 3~4 times a day, once every other day, rotating between the two ears, with the intensity to produce soreness, numbness, swelling, pain and heat in the ear.
Intervention description
The study is conducted 24 hours before and 48 hours after the patient's surgery. The auricular patches needed for this study will be purchased from a fixed manufacturer, and the antiemetic medication will be from the same company.
Criteria for discontinuing or modifying allocated interventions
Patients may withdraw from this study at any time during the study period if they feel any discomfort with the intervention.
Strategies to improve adherence to interventions
First, we will adhere to the principle of voluntary participation of patients in this trial.
We will establish a good relationship with the patients during the experiment to win their trust and cooperation. During the patient's hospitalization, we will strengthen the education on postoperative nausea and vomiting, knowledge of gastrointestinal function recovery, and knowledge of AA, a Chinese medicine nursing technique, to draw the patient's attention to this trial; and explain to the patient the purpose of the study, the content of the intervention, and how the patient needs to cooperate. During the education process, we pay attention to user-friendly language, maintain a gentle and friendly attitude, and show due compassion to make patients feel relieved and trust the researcher. We will also inform patients about possible adverse reactions and treatments during treatment, which will help reduce patients' non-compliance.
Relevant concomitant care permitted or prohibited during the trial
No changes to the usual care pathway are required for this study, and these elements of care will be used for all trial groups.
Provisions for post-trial care
There is no anticipated harm and compensation for trial participation.
Outcomes
1. Baseline data
a. Demographic data included: demographic data were recorded using our designed basic data questionnaire, including marital status, occupation, education level, history of smoking, history of alcohol consumption, history of previous surgery, history of the previous PONV, history of PONV, menstrual status, whether auricular pressure treatment had been performed, and whether auricular pressure was considered effective.
b. Clinical data included: anesthesia protocol, operation time, anesthesia time, intraoperative blood loss, intraoperative blood transfusion, vital signs (temperature, heart rate, respiratory rate, blood pressure) and other data.
2. Primary outcome measure
Each patient will be assessed for PONV three times during the study using the INVR scale at 12h, 24h and 48h after the end of the procedure.
3. Secondary outcome measures
Time of the first PONV
Time to the first anal evacuation of bowels
Time to resume fluid intake after surgery
Time to first postoperative bedtime activity
Study endpoint: patients 48h postoperatively.
Participant timeline
A nursing postgraduate who knows the grouping will conduct the study to document and assess the patients. The INVR scale will be used to assess the patient's PONV three times during the trial with 12h postoperatively, 24h postoperatively and 48h postoperatively, as well as to record secondary observations of the patient at any time. After obtaining informed consent from patients, patients in the experimental group will receive auricular pressure 1-2 times within 24h preoperatively, 3-4 times within 24h postoperatively, and 2-3 times within 48h postoperatively.
Sample size
The literature reports that PONV is still as high as 70% with the routine use of antiemetics after LSG. This study expects the incidence of PONV in the experimental group to be reduced to 35%; the study was divided into 2 groups, the test criteria α = 0.05, test efficacy 1-β = 0.90, based on the above parameters, Calculating the sample size according to this formula
, yielding n1=n2=42 cases, resulting in a sample size of 42 cases per group and an expected potential loss to follow-up of 20%, for a total of 100 patients to be recruited (approximately 50 patients per group).
Recruitment
Before starting this study, we introduced the study in detail to the head of the Department of Metabolic and Bariatric Surgery of Jinan University, obtained their consent, and then started this study.
The study content was explained to the participants one day before the participants' surgery, and the participants were asked if they had volunteered to participate in this study.
Assignment of interventions: allocation
Sequence generation
Patients participating in the trial will be randomly assigned to either the experimental group (ear group) or the control group (blank group). A simple random sequence will then be generated by a member of the study team according to a random number table, and the sequence will be placed in a sealed and opaque envelope. Female patients who meet the inclusion and exclusion criteria, sign an informed consent form, and ultimately undergo LSG will be given a random number that corresponds to the previous simple randomization sequence corresponding to the previous simple randomization sequence. An investigator opens the envelope at the end of the experiment in front of the patient to unblind her.
Concealment mechanism
This was not applicable because the participants could see who administered auricular compression therapy and only used conventional antiemetic therapy.
Implementation
The randomization sequence was generated by one researcher according to a random number table, and another researcher was responsible for registering the allocation between groups.
Assignment of interventions: Blinding
In this study, the researchers responsible for the statistical data are blind. In addition, the experimental process will periodically evaluate whether the experimental process conforms to the CONSORT statement. Variables that do not fall within the scope of intervention but may affect the study results were recorded.
The study design was open, and only the outcome entrants were blinded, so there was no unblinding.
Data collection and management
On the day of the study, patients were asked if they volunteered to participate in the study and were surveyed using a specially designed paper-based questionnaire that included patient demographics, history of PONV and any other causes of nausea and vomiting other than surgery, as well as knowledge of AA therapy and whether they had received it previously.
In this study, the INVR scale was used to assess PONV in patients. The INVR scale assesses the severity of PONV within 12 hours using three dimensions: nausea, vomiting, and dry vomiting, as well as the frequency, duration, and severity of each of the three symptoms, and is scored on a five-point Likert scale. The higher the score, the more severe the PONV, Mei R. Fu51[23] and other scholars Chineseized the INVR scale in 2002 and applied it to measure nausea and vomiting in oncology patients undergoing chemotherapy and mothers. The advantages of this scale are: (1) it is evaluated once every 12 hours, and the time division is accurate; (2) the symptoms of nausea, vomiting and dry vomiting can be evaluated separately, and the symptoms of nausea, vomiting and dry vomiting can also be scored together; (3) it is convenient for clinical workers to grasp the situation of patients more comprehensively, and in clinical medical research, each symptom can also be studied separately, and the data obtained are count data, which is convenient for subsequent statistical analysis. The INVR scale is the most accurate evaluation tool among the currently available evaluation tools. Therefore, the INVR scale was selected to evaluate patients' PONV symptoms in this study.
A researcher visited the patient daily for 24 hours before and 48 hours after surgery to inquire about PONV, observe whether the auricular patch was in the appropriate position, and observe whether the patient was experiencing any adverse effects from the AA treatment, and also to inform the patient to notify the health care provider of any discomfort.
Data management
To ensure the research quality, it has been revised by relevant experts of the Department of Metabolic and Bariatric Surgery of Jinan University, acupuncture experts, medical statisticians and research Methodists. Finally, strict inclusion and exclusion criteria were established. To ensure the objectivity of the data, the data entry personnel are blind, and the implementation personnel of the project have completed the training in auricular point sticking therapy. The experimental materials used in this study are purchased uniformly. In conclusion, this study can ensure that the findings of the experiment are reliable. We require the researchers to be careful in the data entry and attach the corresponding evaluation report. The original data cannot be changed at will. If it needs to be modified, a detailed description should be made and signed by the staff who modified. This study includes two levels of quality inspection systems. The first level is quality control inspection. A quality inspector appointed by the study leader will design a quality checklist and monitor all raw data, data reports and adverse event records according to the checklist. The second level is quality supervision. Quality supervision is assumed by the research team leader, who is responsible for (1) monitoring the whole process of research design and project implementation of researchers; (2) Confirm the authenticity, accuracy and completeness of data records and CRF-related data; (3) Ensure the consistency of original data.
Confidentiality
All patients participating in this study will be assigned a number, and all data on participants will be stored securely in a computer dedicated to the study, requiring a password to access this data.
The collection and processing of personal data on participants enrolled in this study will be limited to those aspects necessary for this study.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use
This study did not involve the collection of biological specimens.
Statistical methods
Statistical analysis was performed using SPSS 27.0 software and analyzed data were expressed as mean ± standard deviation, median (four-digit range), or numbers (percentages). To compare the general information and clinical characteristics of the two groups, the Shapiro - Wilk test was used to confirm the normal distribution of the data. A two-sample t-test was then used for analysis; otherwise, the Wilcoxon rank sum test was used. The Pearson chi-square test or Fisher exact test was used to compare the differences in the incidence of PONV between the two groups.
We do not anticipate that this study will present problems that would be harmful to participants, and therefore, no interim analysis will be conducted.
Methods for additional analyses
No subgroup analysis was required for this study.
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data
Participants with complete data will be analyzed using the statistical methods in the study protocol, and for participants with only pre- or post-intervention data, we will exclude such data.
Plans to give access to the full protocol, participant level-data and statistical code
Public access will be granted to the full protocol, participant-level dataset and statistical code.
Oversight and monitoring
Composition of the coordinating centre and trial steering committee
Collaborating centre:
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Jinan university
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The First Affiliated Hospital of Jinan University
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Luoyang Hospital of traditional Chinese medicine
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Study site
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Guangzhou City, Guangdong Province, China
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Luoyang City, Henan Province, China
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Sponsor:
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Jinan university
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The First Affiliated Hospital of Jinan University
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Principal investigator:
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Qingran Lin
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School of Nursing, Jinan University, Guangzhou, Guangdong, China.
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No.601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province, China
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E-mail: [email protected]
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Wah Yang
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Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital, Jinan University, Guangzhou, China
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No.613, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province, China
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E-mail: [email protected]
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Co-investigators:
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Zhonghui Han
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School of Nursing, Jinan University, Guangzhou, Guangdong, China.
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No.601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province, China
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E-mail: [email protected]
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Hanlin Tang
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Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital, Jinan University, Guangzhou, China
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No.613, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province, China
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E-mail : [email protected]
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Lilian Gao
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Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital, Jinan University, Guangzhou, China
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No.613, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province, China
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E-mail: [email protected]
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Collaborators:
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Peng Qin
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Acupuncture and Moxibustion,The First Affiliated Hospital, Jinan University, Guangzhou, China
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No.613, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province, China
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E-mail: [email protected]
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Lili Zhang
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Luoyang Hospital of traditional Chinese medicine
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Xigong District, Luoyang City, Henan Province, China
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E-mail: [email protected]
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Min Hou
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School of Nursing, Jinan University, Guangzhou, Guangdong, China.
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No.601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province, China
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E-mail: [email protected]
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Xiyang Wu
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College of Science and Engineering, Jinan University, Guangzhou, Guangdong, China
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No.601, Huangpu Avenue West, Tianhe District, Guangzhou City,Guangdong Province, China
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E-mail : [email protected]
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Composition of the data monitoring committee, its role and reporting structure
The event will be investigated by our safety supervisor, an experienced nurse, who will interview the subject, check the subject's health status and fill out an adverse event form if an adverse event occurs.
Adverse event reporting and harms
When an adverse event occurs, whether or not it is related to the treatment method of this study, researchers involved in the treatment of the subject should keep detailed records, including the time of occurrence, the time of discontinuation and the duration of the event (which can be recorded in days or h), the severity and frequency, the treatment method and results. The analysis of the causal relationship between the adverse event and the trial treatment method, the follow-up of adverse events and serious adverse events, etc. All clinical information about the adverse event should be kept in the original file.
Frequency and plans for auditing trial conduct
The trial steering group and ethics committee will review the entire trial process.
Plans for communicating important protocol amendments to relevant parties
During the review process, the results of amendments to the study protocol will be submitted to the Ethics Committee for review and approval, and subjects will be informed of changes in the study.
Dissemination plans
The results of this study will be disseminated through participation in academic conferences and the publication of academic papers.