Postoperative Nausea and VomitingNCT05757986
Predictive Model for PONV for Patient Received Gynecological Laparoscopic Surgery
An observational study of Postoperative Nausea and Vomiting, run by Jiang Liu at 1 site in China.
Trial summary
This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- The presence of nausea and vomiting within 24 hours after surgery
- How many people
- 659 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Oct 2023
- 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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The female patients with gynecological diseases and requiring gynecological laparoscopic surgery.
Who may be able to join
- -All female patients receiving gynecological laparoscopic surgery.
Who cannot join
- -Patients requiring intraoperative open-surgery, requiring other procedures in addition to gynecological laparoscopy, with severe organ dysfunction, unstable postoperative vital signs or requiring transfer to ICU.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Weifang Medical University
Weifang, Shangdong, 261000
YuXiu Liu, Ph.D, +8618663608162, 18663608162@163.com
About this study
Official title: Dynamic Predictive Model for Postoperative Nausea and Vomiting for Patient Received Gynecological Laparoscopic Surgery
This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- The presence of nausea and vomiting within 24 hours after surgery
- 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.
The presence of nausea and vomiting within 24 hours after surgeryOther
This is a prospective risk prediction model building, thus there is no traditional definition of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Not described Receives: Other: The presence of nausea and vomiting within 24 hours after surgery | |
| Control group | Not described Receives: Other: The presence of nausea and vomiting within 24 hours after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV
The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS).
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion1 Oct 2023 (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.
- 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
- 659 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiang Liu, Weifang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757986
- Sponsor's protocol ID
- 2023YX030
- Status last verified
- Jun 2023
- First submitted
- 22 Feb 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Predictive Model for Postoperative Nausea and Vomiting for Patient Received Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05757986
- Acronym / sponsor ID
- 2023YX030
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 659 participants (estimated)
- Lead sponsor
- Jiang LiuUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 7 Mar 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.
This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: The presence of nausea and vomiting within 24 hours after surgery |
| Control group | – | Other: The presence of nausea and vomiting within 24 hours after surgery |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The female patients with gynecological diseases and requiring gynecological laparoscopic surgery.
Key inclusion criteria (1 listed)
- -All female patients receiving gynecological laparoscopic surgery.
Key exclusion criteria (1 listed)
- -Patients requiring intraoperative open-surgery, requiring other procedures in addition to gynecological laparoscopy, with severe organ dysfunction, unstable postoperative vital signs or requiring transfer to ICU.
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 |
|---|---|---|
| The presence of nausea and vomiting within 24 hours after surgeryThis is a prospective risk prediction model building, thus there is no traditional definition of intervention. | Other | Control group, Experimental group |
Primary outcome
PONV
Time frame: Within 24 hours after surgery
The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
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, run by Jiang Liu 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 1 inclusion and 1 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 15 Jun 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?
Contact YuXiu Liu, Ph.D (+8618663608162, 18663608162@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV (time frame: Within 24 hours after surgery). 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 15 Jun 2023.