Gynecologic NursingNCT06524752
Risk Factors for PONV in Patients Undergoing Hysteroscopic Surgery
An observational study of Gynecologic Nursing and Postoperative Complications, run by Weifang Medical University at 1 site in China.
Trial summary
The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Nursing, Postoperative Complications
- What is being tested?
- The presence of nausea and vomiting within 24 hours after surgery and Non-existence of nausea and vomiting within 24 hours after surgery
- How many people
- 1,583 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jun 2024
- How long will I take part?
- 1 Day
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients undergoing gynaecological hysteroscopic day-case surgery.
Who may be able to join
- Female patients undergoing hysteroscopic day-case surgery and aged 18 years.
Who cannot join
- Patients with intraoperative change of surgical method and unstable postoperative vital signs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecologic Nursing, Postoperative Complications
- Being tested
- The presence of nausea and vomiting within 24 hours after surgery, Non-existence of nausea and vomiting within 24 hours after surgery
- Keywords
- PONV, Risk factor, Nursing
- Medical subject headings
- Postoperative Complications, 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | The patient experience the postoperative nausea or vomiting Receives: Other: The presence of nausea and vomiting within 24 hours after surgery | |
| Control group | The patient did not experience postoperative nausea or vomiting Receives: Other: Non-existence 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). The VAS scale ranges from 0 to 10, with larger scores meaning that the patient has more severe PONV.
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 posted29 Jul 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic NursingStudies 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
- 1,583 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Weifang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Liu, Weifang Medical University
- Investigators
- Shirong Fang, Researcher, Study director, Weifang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524752
- Sponsor's protocol ID
- KYLL20230217-3
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Day-case Hysteroscopic Surgery
- ClinicalTrials.gov ID
- NCT06524752
- Acronym / sponsor ID
- KYLL20230217-3
- Conditions
- Gynecologic Nursing, Postoperative Complications
- Keywords
- PONV, Risk factor, Nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,583 participants (actual)
- Lead sponsor
- Weifang Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 29 Jul 2024 (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.
The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Other: The presence of nausea and vomiting within 24 hours after surgeryThe patient experience the postoperative nausea or vomiting |
| Control group | – | Other: Non-existence of nausea and vomiting within 24 hours after surgeryThe patient did not experience postoperative nausea or vomiting |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients undergoing gynaecological hysteroscopic day-case surgery.
Key inclusion criteria (1 listed)
- Female patients undergoing hysteroscopic day-case surgery and aged 18 years.
Key exclusion criteria (1 listed)
- Patients with intraoperative change of surgical method and unstable postoperative vital signs.
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 | Observation group |
| Non-existence 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Gynecologic Nursing
Not yet recruiting
Effects of a Self-Regulation Based E-MOTE Program Delivered Via an AI-Assisted Robot and Supported by Mobile Platforms for Newly Diagnosed Gynecologic Cancer Patients
Nursing, Gynecological Cancers
Recruiting
Emotional Assessment and Tiered Individualized Psychological Support of the Artificial Intelligence Robot
Emotional Assessment, Nursing
Recruiting
The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life
Gynecologic Cancer
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.
Shirong Fang, Researcher study director
Weifang People's Hospital
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 Gynecologic Nursing and Postoperative Complications, run by Weifang Medical University 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: finished, as of the sponsor's last update on 29 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 29 Jul 2024.