Laparoscopic Sleeve GastrectomyNCT05873270
Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Acupuncture Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women
An observational study of Laparoscopic Sleeve Gastrectomy and Postoperative Nausea and Vomiting, run by LILIAN GAO at 1 site in China.
Trial summary
PONV is the most common clinical presentation after surgical procedures beyond pain. A retrospective study of our center found that the postoperative incidence of LSG was 77.4%. PONV can not only cause postoperative discomfort, but also cause serious complications such as disturbance water and electrolyte balance… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy, Postoperative Nausea and Vomiting
- What is being tested?
- Wrist and ankle acupuncture
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patient undergoing sleeve gastric surgery in the weight loss center of the First Affiliated Hospital of Jinan University
Who may be able to join
- In accordance with the Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes in China (2019 edition);
- ASA grades II-III; Age: 18-65 years old;
- Denial of smoking history;
- Denied any history of motion sickness or PONV;
- Female patients proposed to undergo laparoscopic sleeve gastrectomy under elective general anesthesia;
- Voluntary attended and signed informed consent.
Who cannot join
- With known drug allergies related to this study;
- Severe heart, respiratory, renal or liver diseases, and coagulation disorders;
- Psychiatric or neurological disorders;
- difficulties in communication;
- Premedication or premedical conditions limits target assessment, including use of antiemetics, opioids or corticosteroids (excluding anesthetic medication);
- Gastroesophageal reflux (GRED), clinically assessed as severe GRED or preoperative gastroscopy indicating grade B of oesophagitis or above;
- Patients undergoing combined cholecystectomy and gynecological surgery during the operation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Jinan University
Guangdong, Guangzhou, 510600
About this study
Official title: Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Needle Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women
PONV is the most common clinical presentation after surgical procedures beyond pain. A retrospective study of our center found that the postoperative incidence of LSG was 77.4%. PONV can not only cause postoperative discomfort, but also cause serious complications such as disturbance water and electrolyte balance, wound splitting, incisional hernia, and even residual gastric leakage and aspiration pneumonia, resulting in prolonged hospital stay and increased medical costs. Wrist and ankle acupuncture is a special kind of acupuncture therapy. Through subcutaneous stimulation, the electrical signal is fed back along the nerve fiber into the cerebral cortex, without dialectical treatment, and only needs the appropriate symptoms and signs of the patient. Although only in the wrist and ankle, it can solve a series of problems in the whole body, especially nausea, vomiting and pain symptoms.
Read the detailed description
Patients scheduled for female sleeve gastric surgery were selected, and the trial was designed into the control group (n=33) and the intervention group (33). The intervention group was based on the control group, combined with the intervention of the wrist and ankle acupuncture, namely, the wrist and ankle acupuncture treatment was started 1 day before the surgery. Take up and down 1,2 area as a needle point, use hua tuo brand sterile acupuncture needle (specification: 0.25mm 25mm), into the skin disinfection into the needle, keep 30 subcutaneous needle and skin, when the operator under the needle, patients without acid swelling, pain, close to the skin dermis, to about 1.5 inches, give tape fixed 24h, left under the skin, until postoperative 3 day.
- Being tested
- Wrist and ankle acupuncture
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist and ankle acupunctureOther
Patients in the intervention arm started the wrist and ankle acupuncture treatment 1 day before the surgery. Take up and down 1,2 area as a needle point, use hua tuo brand sterile acupuncture needle (specification: 0.25mm 25mm), into the skin disinfection into the needle, keep 30 subcutaneous needle and skin, when the operator under the needle, patients without acid swelling, pain, close to the skin dermis, to about 1.5 inches, give tape fixed 24h, left under the skin, until postoperative 3 day.
| Study group | Role | What they receive |
|---|---|---|
| control group | Not described | |
| Intervention group | Not described Receives: Other: Wrist and ankle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline pain at 24 hours after surgery
Using Visual Analogue Scale of Pain (VASP), a score 0 represents no significant pain in the past time period; a score 1-3 represents mild pain that does not affect sleep; a score 4-6 means moderate pain that slightly affects sleep; and a score 7-10 represents severe pain leading to poor sleep or painful awakening from sleep
Measured: Change from Baseline pain at 24 hours after surgery
Change from Baseline nausea and vomitting at 24 hours after surgery
PONV was scored using the Visual Nausea analog core (Visual Analog Scale of Nausea, VASN).0 represents no significant nausea and vomiting in the past period; 1-3 represents mild PONV does not affect sleep; 4-6 represents moderate PONV slightly affects sleep; and 7-10 represents severe PONV causes failed to sleep. The simplified PONV impact scale was used while performing the VASN score. The assessment of PONV severity was performed to ensure the objectivity of the outcome measures evaluation. The simplified questionnaire consisted of 2 questions, each with the corresponding score, scoring 5 points defined as clinically significant PONV
Measured: Change from Baseline nausea and vomitting at 24 hours after surgery
Secondary outcomes (4)
Gastrointestinal function
The time of first exhaust and defecation were recorded.
Measured: Before discharge
drug used
The number, type, and duration of use of analgesic and antiemetic drugs when necessary
Measured: Before discharge
Quality of life situation before discharge
The quality of recovery before discharge was recorded
Measured: Before discharge
complication
The occurrence of perioperative complications was recorded
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start23 Mar 2023
- Primary completion23 Mar 2024 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Sleeve GastrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LILIAN GAO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LILIAN GAO, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873270
- Sponsor's protocol ID
- LGAO
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Needle Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women
- ClinicalTrials.gov ID
- NCT05873270
- Acronym / sponsor ID
- LGAO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- LILIAN GAOUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 23 Mar 2024 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PONV is the most common clinical presentation after surgical procedures beyond pain. A retrospective study of our center found that the postoperative incidence of LSG was 77.4%. PONV can not only cause postoperative discomfort, but also cause serious complications such as disturbance water and electrolyte balance, wound splitting, incisional hernia, and even residual gastric leakage and aspiration pneumonia, resulting in prolonged hospital stay and increased medical costs. Wrist and ankle acupuncture is a special kind of acupuncture therapy. Through subcutaneous stimulation, the electrical signal is fed back along the nerve fiber into the cerebral cortex, without dialectical treatment, and only needs the appropriate symptoms and signs of the patient. Although only in the wrist and ankle, it can solve a series of problems in the whole body, especially nausea, vomiting and pain symptoms.
Detailed description
Patients scheduled for female sleeve gastric surgery were selected, and the trial was designed into the control group (n=33) and the intervention group (33). The intervention group was based on the control group, combined with the intervention of the wrist and ankle acupuncture, namely, the wrist and ankle acupuncture treatment was started 1 day before the surgery. Take up and down 1,2 area as a needle point, use hua tuo brand sterile acupuncture needle (specification: 0.25mm 25mm), into the skin disinfection into the needle, keep 30 subcutaneous needle and skin, when the operator under the needle, patients without acid swelling, pain, close to the skin dermis, to about 1.5 inches, give tape fixed 24h, left under the skin, until postoperative 3 day.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | – |
| Intervention group | – | Other: Wrist and ankle acupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patient undergoing sleeve gastric surgery in the weight loss center of the First Affiliated Hospital of Jinan University
Key inclusion criteria (6 listed)
- In accordance with the Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes in China (2019 edition);
- ASA grades II-III; Age: 18-65 years old;
- Denial of smoking history;
- Denied any history of motion sickness or PONV;
- Female patients proposed to undergo laparoscopic sleeve gastrectomy under elective general anesthesia;
Key exclusion criteria (7 listed)
- With known drug allergies related to this study;
- Severe heart, respiratory, renal or liver diseases, and coagulation disorders;
- Psychiatric or neurological disorders;
- difficulties in communication;
- Premedication or premedical conditions limits target assessment, including use of antiemetics, opioids or corticosteroids (excluding anesthetic medication);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist and ankle acupuncturePatients in the intervention arm started the wrist and ankle acupuncture treatment 1 day before the surgery. Take up and down 1,2 area as a needle point, use hua tuo brand sterile acupuncture needle (specification: 0.25mm 25mm), into the skin disinfection into the needle, keep 30 subcutaneous needle and skin, when the operator under the needle, patients without acid swelling, pain, close to the skin dermis, to about 1.5 inches, give tape fixed 24h, left under the skin, until postoperative 3 day. | Other | Intervention group |
Primary outcome
Change from Baseline pain at 24 hours after surgery
Time frame: Change from Baseline pain at 24 hours after surgery
Using Visual Analogue Scale of Pain (VASP), a score 0 represents no significant pain in the past time period; a score 1-3 represents mild pain that does not affect sleep; a score 4-6 means moderate pain that slightly affects sleep; and a score 7-10 represents severe pain leading to poor sleep or painful awakening from sleep
Change from Baseline nausea and vomitting at 24 hours after surgery
Time frame: Change from Baseline nausea and vomitting at 24 hours after surgery
PONV was scored using the Visual Nausea analog core (Visual Analog Scale of Nausea, VASN).0 represents no significant nausea and vomiting in the past period; 1-3 represents mild PONV does not affect sleep; 4-6 represents moderate PONV slightly affects sleep; and 7-10 represents severe PONV causes failed to sleep. The simplified PONV impact scale was used while performing the VASN score. The assessment of PONV severity was performed to ensure the objectivity of the outcome measures evaluation. The simplified questionnaire consisted of 2 questions, each with the corresponding score, scoring 5 points defined as clinically significant PONV
4 secondary outcomes
Gastrointestinal function
Time frame: Before discharge
drug used
Time frame: Before discharge
Quality of life situation before discharge
Time frame: Before discharge
complication
Time frame: perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Sleeve Gastrectomy and Postoperative Nausea and Vomiting, run by LILIAN GAO at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline pain at 24 hours after surgery (time frame: Change from Baseline pain at 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.