Predictive Model for PONV for Patient Received Gynecological Laparoscopic Surgery

June 13, 2023 updated by: Jiang Liu

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

659

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shangdong
      • Weifang, Shangdong, China, 261000
        • Recruiting
        • Weifang Medical University
        • Contact:

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The female patients with gynecological diseases and requiring gynecological laparoscopic surgery.

Description

Inclusion Criteria:

-All female patients receiving gynecological laparoscopic surgery.

Exclusion Criteria:

-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.

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
Control group
Other: The presence of nausea and vomiting within 24 hours after surgery
This is a prospective risk prediction model building, thus there is no traditional definition of intervention.
Experimental group
Other: The presence of nausea and vomiting within 24 hours after surgery
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).
Within 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiang Liu

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)

September 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023YX030

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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