NCT06524752

Brief Summary

The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,583

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

July 22, 2024

Last Update Submit

July 26, 2024

Conditions

Gynecologic NursingPostoperative Complications

Keywords

PONVRisk factorNursing

Outcome Measures

Primary Outcomes (1)

  • PONV

    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

Study Arms (2)

Observation group

The patient experience the postoperative nausea or vomiting

Other: The presence of nausea and vomiting within 24 hours after surgery

Control group

The patient did not experience postoperative nausea or vomiting

Other: Non-existence 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.

Observation group
Non-existence 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 group

Eligibility Criteria

Age18 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 day-case hysteroscopic surgery. Therefore, the target population of this study was limited to female patients with gynecologic diseases and requiring day-case hysteroscopic surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients undergoing gynaecological hysteroscopic day-case surgery.

You may qualify if:

  • Female patients undergoing hysteroscopic day-case surgery and aged 18 years.

You may not qualify if:

  • Patients with intraoperative change of surgical method and unstable postoperative vital signs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weifang People's Hospital

Weifang, Shandong, 265100, China

Location

MeSH Terms

Conditions

Postoperative ComplicationsPostoperative Nausea and Vomiting

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Shirong Fang, Researcher

    Weifang People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research investigator

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 29, 2024

Study Start

January 1, 2021

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)