Postoperative Nausea and VomitingNCT05014737
External Validation of the Apfel Risk Score and Koivuranta Score to Predict Postoperative Nausea and Vomiting in Patients With Liver Cancer
An observational study of Postoperative Nausea and Vomiting and Hepatobiliary Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Postoperative nausea and vomiting (PONV) is a common complication among surgical patients. The incidence ranging from 20% to 50% depends on different population studied. Clinical practice guidelines recommend routine PONV screening before surgery using the Apfel simplified risk score OR Koivuranta score. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Hepatobiliary Surgery, Prediction Model
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 May 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving hepatobiliary surgery will be consectively invited, and PONV will be assessed within 24 hours after surgery．
Who may be able to join
- patients receiving hepatobiliary surgery
Who cannot join
- patients receiving chemothreapy；patients with cognitive disorders; patients unwilling to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Yuxia Zhang, Phd, 13816881925, zhang.yx@aliyun.com
About this study
Official title: External Validation of Two Models to Predict Postoperative Nausea and Vomiting (PONV) in Patients With Liver Cancer in Chinese Hospital Setting
Postoperative nausea and vomiting (PONV) is a common complication among surgical patients. The incidence ranging from 20% to 50% depends on different population studied. Clinical practice guidelines recommend routine PONV screening before surgery using the Apfel simplified risk score OR Koivuranta score. However, these two scores haven't been translated into Chinese version and tested for psychometric qualities. Therefore, this study aim to externally validate two PONV prediction models in the Chinese hospital setting for PONV assessment.
- Being tested
- no intervention
- Keywords
- Postoperative Nausea and Vomiting, hepatobiliary surgery, assessment tool
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is an abservational study and no intervention will be involved
| Study group | Role | What they receive |
|---|---|---|
| Patients with low risk of PONV | Not described | |
| Patients with high risk of PONV | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
Postoperative nausea will be assessed at 24 hours after surgery on an 11-point numeric scale (0 -10) by a trained nurse. Patients will be asked to respond to the question, "Have you felt nauseated since your discharge from the postanesthetic care unit and if so, what would be the average level of nausea you have felt until now on a 0 to 10 scale?". Patients will be considered nauseated if postoperative nausea is reported to be greater than zero on the 11-point scale with the question. For the same intervals the number of episodes of postoperative vomiting will be recorded. Again, patients will be considered to have vomited if postoperative vomiting occurs at least once within 24 hours. Patients who have either postoperative nausea or postoperative vomiting in 24h will be considered to have PONV.
Measured: 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 posted20 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2021
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014737
- Sponsor's protocol ID
- B2020-347
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available when asked with reasonable reasons.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of Two Models to Predict Postoperative Nausea and Vomiting (PONV) in Patients With Liver Cancer in Chinese Hospital Setting
- ClinicalTrials.gov ID
- NCT05014737
- Acronym / sponsor ID
- B2020-347
- Keywords
- Postoperative Nausea and Vomiting, hepatobiliary surgery, assessment tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 20 Aug 2021 (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.
Postoperative nausea and vomiting (PONV) is a common complication among surgical patients. The incidence ranging from 20% to 50% depends on different population studied. Clinical practice guidelines recommend routine PONV screening before surgery using the Apfel simplified risk score OR Koivuranta score. However, these two scores haven't been translated into Chinese version and tested for psychometric qualities. Therefore, this study aim to externally validate two PONV prediction models in the Chinese hospital setting for PONV assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with low risk of PONV | – | – |
| Patients with high risk of PONV | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving hepatobiliary surgery will be consectively invited, and PONV will be assessed within 24 hours after surgery．
Key inclusion criteria (1 listed)
- patients receiving hepatobiliary surgery
Key exclusion criteria (1 listed)
- patients receiving chemothreapy；patients with cognitive disorders; patients unwilling to participate.
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 |
|---|---|---|
| no interventionthis is an abservational study and no intervention will be involved | Other | Patients with high risk of PONV |
Primary outcome
postoperative nausea and vomiting
Time frame: 24 hours after surgery
Postoperative nausea will be assessed at 24 hours after surgery on an 11-point numeric scale (0 -10) by a trained nurse. Patients will be asked to respond to the question, "Have you felt nauseated since your discharge from the postanesthetic care unit and if so, what would be the average level of nausea you have felt until now on a 0 to 10 scale?". Patients will be considered nauseated if postoperative nausea is reported to be greater than zero on the 11-point scale with the question. For the same intervals the number of episodes of postoperative vomiting will be recorded. Again, patients will be considered to have vomited if postoperative vomiting occurs at least once within 24 hours. Patients who have either postoperative nausea or postoperative vomiting in 24h will be considered to have PONV.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: Yes. Individual participant data will be available when asked with reasonable reasons.
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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.
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 Postoperative Nausea and Vomiting and Hepatobiliary Surgery, run by Shanghai Zhongshan Hospital 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: status not confirmed, as of the sponsor's last update on 1 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxia Zhang, phd (13816881925, zhang.yx@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea and vomiting (time frame: 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 1 Apr 2022.