Postoperative Nausea and VomitingNCT03795766
Nausea and Vomiting After Gynecologic Surgery
An observational study of Postoperative Nausea and Vomiting and Gynecologic Surgery, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
In this cross-section study, all patients in the gynecologic ward of Peking Union Medical College Hospital will accepted a survey about the prevalence and severity of nausea and vomiting according to visual analogue scale and WHO classification. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting, Gynecologic Surgery
- What is being tested?
- Surgeries for gynecologic disease
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients accept elective surgeries for gynecologic disease with good performance status.
Who may be able to join
- Aged 18 years or older
- Elective surgeries for gynecologic disease
- Good performance status
- Signed an approved informed consents
- Post-operative stay 72 hours or longer
Who cannot join
- Emergency surgeries
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Prevalence and Predictors of Nausea and Vomiting After Gynecologic Surgery: a Cross-section Study
In this cross-section study, all patients in the gynecologic ward of Peking Union Medical College Hospital will accepted a survey about the prevalence and severity of nausea and vomiting according to visual analogue scale and WHO classification. Epidemiological, surgical, anaesthetic characteristics and post-operative treatment are considered as predictors for the post-operative nausea and vomiting. The primary objective is the incidence of nausea and vomiting. The secondary objective is the possible predictors of nausea and vomiting.
- Being tested
- Surgeries for gynecologic disease
- 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.
Surgeries for gynecologic diseaseProcedure or surgery
All patients accept surgeries for gynecologic disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative nausea and vomiting
Incidence of post-operative nausea and vomiting
Measured: 72 hours post-operative
Secondary outcomes (2)
Severity of post-operative nausea and vomiting by visual analogue scale
Severity of post-operative nausea and vomiting according to the visual analogue scale. In th scale, 0 denotes none, 10 denotes the most severe conditions. The scale will be judged by the patients.
Measured: 72 hours post-operative
Severity of post-operative nausea and vomiting by World Health Organization classification
Severity of post-operative nausea and vomiting according to World Health Organization (WHO) classification. In WHO classfication, I denotes none, II, III and IV denote mild, moderate and severe conditions.
Measured: 72 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795766
- Sponsor's protocol ID
- GY-PONV
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictors of Nausea and Vomiting After Gynecologic Surgery: a Cross-section Study
- ClinicalTrials.gov ID
- NCT03795766
- Acronym / sponsor ID
- GY-PONV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 8 Jan 2019 (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.
In this cross-section study, all patients in the gynecologic ward of Peking Union Medical College Hospital will accepted a survey about the prevalence and severity of nausea and vomiting according to visual analogue scale and WHO classification. Epidemiological, surgical, anaesthetic characteristics and post-operative treatment are considered as predictors for the post-operative nausea and vomiting. The primary objective is the incidence of nausea and vomiting. The secondary objective is the possible predictors of nausea and vomiting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients accept elective surgeries for gynecologic disease with good performance status.
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Elective surgeries for gynecologic disease
- Good performance status
- Signed an approved informed consents
- Post-operative stay 72 hours or longer
Key exclusion criteria (2 listed)
- Emergency surgeries
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| Surgeries for gynecologic diseaseAll patients accept surgeries for gynecologic disease. | Procedure or surgery | – |
Primary outcome
Incidence of post-operative nausea and vomiting
Time frame: 72 hours post-operative
Incidence of post-operative nausea and vomiting
2 secondary outcomes
Severity of post-operative nausea and vomiting by visual analogue scale
Time frame: 72 hours post-operative
Severity of post-operative nausea and vomiting by World Health Organization classification
Time frame: 72 hours post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
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 Postoperative Nausea and Vomiting and Gynecologic Surgery, run by Peking Union Medical College Hospital 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 5 inclusion and 2 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 8 Jan 2019. 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?
Contact Lei Li (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-operative nausea and vomiting (time frame: 72 hours post-operative). 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 8 Jan 2019.