A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer

NCT06356623 | Not Yet Recruiting

• 1 other identifier: SHDC2202020401
• Study Type: observational
• Target: 476
• Locations: 0 countries
• Sites: N/A

Brief Summary

PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice.

Conditions

Nausea and Vomiting, Postoperative; Liver Cancer

Keywords

liver cancer; Nausea and Vomiting, Postoperative; risk score

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting

  PONV will be evaluated on a four-grade scale from 0 (no nausea and no vomiting), 1 (having nausea but no vomiting), 2 (having vomiting without stomach contents) to 3 (having vomiting with stomach contents).

  Postoperative nausea and vomiting will be assessed every hour during the first two hours, every two hours for the following four hours and every four hours until the 24th hour

Study Arms (2)

patients with PONV

Other: 1

patients without PONV

Interventions

1 OTHER

this is not an intervention study

patients with 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 who are diagnosed with liver cancer and underwent hepatectomy will be eligible.

You may qualify if:

• Patients who are diagnosed with liver cancer and underwent hepatectomy
• Patients who are older than 18 years
• Patients who have planned admissions and elective surgery, and stay at least 24 hours in the surgical unit.

You may not qualify if:

• Patients with cognitive impairment
• Patients with nausea and vomiting related to other existing diseases, such as gastroesophageal reflux disease.
• Patients with severe postoperative complications, including massive abdominal hemorrhage, hepatic encephalopathy and portal vein thrombosis.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Liver Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Yuxia Zhang, Ph.D

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: April 5, 2024
• First Posted: April 10, 2024
• Study Start: May 5, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 6, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04