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

NCT05014737 | Unknown

• 1 other identifier: B2020-347
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting; Hepatobiliary Surgery; Prediction Model

Keywords

Postoperative Nausea and Vomiting; hepatobiliary surgery; assessment tool

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after surgery

Study Arms (2)

Patients with low risk of PONV

Patients with high risk of PONV

Other: no intervention

Interventions

no intervention OTHER

this is an abservational study and no intervention will be involved

Patients with high risk of PONV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving hepatobiliary surgery will be consectively invited, and PONV will be assessed within 24 hours after surgery．

You may qualify if:

• patients receiving hepatobiliary surgery

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Central Study Contacts

Yuxia Zhang, phd

CONTACT

13816881925; zhang.yx@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 20, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)