NCT04986722

Brief Summary

Objective: To evaluate the symptoms of postoperative nausea and vomiting (PONV) in patients undergoing mastectomy with breast cancer according to the Apfel Risk Scoring System. Materials and Methods: The descriptive and cross-sectional study was conducted between June 2020 and August 2020 in the surgical oncology department of a tertiary hospital. A total of 57 female patients who were scheduled for surgical treatment for breast cancer were included in the study. Data including demographic and clinical characteristics of the patients were recorded by face-to-face interview method. The incidence of PONV was evaluated using the Patient Evaluation Form and the Apfel Risk Scoring System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

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

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

June 10, 2021

Last Update Submit

August 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the Apfel risk score before surgery

    Apfel Risk Scoring ; It is a tool in which the patient's previous postoperative nausea, vomiting and/or motion sickness history, non-smoking status, and postoperative opioid use are questioned to assess the patient's postoperative nausea and vomiting (PONV) risk score. The patient is evaluated with the Apfel Risk Score preoperatively. As a result of the evaluation, the patient is considered 0-1 point low risk, 2 points medium risk, and ≥3-4 points high risk for PONV.

    Preoperative 0-1 days

Secondary Outcomes (1)

  • Evaluation of postoperative nausea and vomiting

    Postoperative 0-2 days

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients scheduled for mastectomy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Patients diagnosed with breast cancer, female, scheduled for mastectomy, over 18 years of age and who agreed to participate in the study were included in the study.

You may qualify if:

  • Diagnosed with breast cancer,
  • Have female gender,
  • Mastectomy planned

You may not qualify if:

  • Having speech, comprehension and language barriers
  • Who do not agree to participate in the study,
  • Patients with male gender

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2021

First Posted

August 3, 2021

Study Start

June 1, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations