NCT05894408

Brief Summary

Postoperative nausea and vomiting (PONV) is one of the most common and distressing postoperative complications. PONV risk assessment is recommanded to determine the number of medications or strategies for prophylaxis. Many well-known risk factors have been determined. However, no study has explored liver surgery-specific risk factors. This study aims to identify whether there was an association between portal vein occlusion and PONV among patients after liver surgery. Patients diagnosed with liver cancer and undergoing hepatectomy will be prospectively consecutively recruited. All enrolled patients receive PONV assessments within the first 24 postoperative hours. Logistic regression models will be used to investigate the effects of portal vein occlusion and the other variables on the occurrence of PONV in both univariate and multivariate analyses

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

May 30, 2023

Last Update Submit

April 5, 2024

Conditions

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).

    up to 24 hours

Study Arms (2)

patients with portal vein occlusion

Other: this is no intervention

patients without portal vein occlusion

Other: this is no intervention

Interventions

this is no intervention

patients with portal vein occlusionpatients without portal vein occlusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are diagnosed with liver cancer and underwent hepatectomy are eligible.

You may qualify if:

  • older than 18 years, planned admissions and elective surgery, and staying at least 24 hours in the surgical unit

You may not qualify if:

  • patients with cognitive impairment and patients who have nausea and vomiting related to other existing diseases, such as gastroesophageal reflux disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Chen X, Zhao WJ, Yu J, Zhou H, Shi Y, Gao J, Zhang Y. Duration of hepatic portal occlusion is a valuable predictor for postoperative nausea and vomiting in patients underwent liver resection for liver cancer. BMC Cancer. 2025 Jul 16;25(1):1177. doi: 10.1186/s12885-025-14592-0.

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

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

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 8, 2023

Study Start

June 15, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations