- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06524752
Risk Factors for PONV in Patients Undergoing Hysteroscopic Surgery
July 26, 2024 updated by: Jiang Liu, Weifang Medical University
Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Day-case Hysteroscopic Surgery
The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery.
Study Overview
Status
Completed
Conditions
Detailed Description
This study predicted the risk of postoperative nausea and vomiting in patients undergoing day-case hysteroscopic surgery by constructing and validating a web-based dynamic nomogram.
Study Type
Observational
Enrollment (Actual)
1583
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Weifang, Shandong, China, 265100
- Weifang People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Female patients undergoing gynaecological hysteroscopic day-case surgery.
Description
Inclusion Criteria:
- Female patients undergoing hysteroscopic day-case surgery and aged 18 years.
Exclusion Criteria:
- Patients with intraoperative change of surgical method and unstable postoperative vital signs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observation group
The patient experience the postoperative nausea or vomiting
|
This is a prospective risk prediction model building, thus there is no traditional definition of intervention.
|
|
Control group
The patient did not experience postoperative nausea or vomiting
|
This is a prospective risk prediction model building, thus there is no traditional definition of intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PONV
Time Frame: Within 24 hours after surgery
|
The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS).
The VAS scale ranges from 0 to 10, with larger scores meaning that the patient has more severe PONV.
|
Within 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shirong Fang, Researcher, Weifang People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
January 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
July 22, 2024
First Submitted That Met QC Criteria
July 26, 2024
First Posted (Actual)
July 29, 2024
Study Record Updates
Last Update Posted (Actual)
July 29, 2024
Last Update Submitted That Met QC Criteria
July 26, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLL20230217-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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