External Validation of the Apfel Risk Score and Koivuranta Score to Predict Postoperative Nausea and Vomiting in Patients With Liver Cancer

• Conditions: Prediction Model; Postoperative Nausea and Vomiting; Hepatobiliary Surgery
• Interventions: Other: no intervention

• Registration Number: NCT05014737
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-20
• Study Start: 2021-09-01
• Primary Completion: 2021-12-01
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-04-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• patients receiving hepatobiliary surgery

Exclusion Criteria

• patients receiving chemothreapy；patients with cognitive disorders; patients unwilling to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with high risk of PONV	no intervention	-

Primary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	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.

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China