NCT05757986

Brief Summary

This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
659

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

February 22, 2023

Last Update Submit

June 13, 2023

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • PONV

    The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS).

    Within 24 hours after surgery

Study Arms (2)

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

Interventions

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.

Control groupExperimental group

Eligibility Criteria

Age12 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe objective of this study was to develop a risk prediction model for postoperative nausea and vomiting in patients undergoing gynecologic laparoscopic surgery. Therefore, the target population of this study was limited to female patients with gynecologic diseases and requiring gynecologic laparoscopic surgery.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All female patients receiving gynecological laparoscopic surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weifang Medical University

Weifang, Shangdong, 261000, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Perioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

YuXiu Liu, Ph.D

CONTACT

+861866360816218663608162@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 7, 2023

Study Start

September 1, 2022

Primary Completion

March 1, 2023

Study Completion

October 1, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

CN(1)