Skip to main content
OpenTrials
Completed

NCT Number: NCT04986722

Evaluation of Postoperative Nausea and Vomiting Incidence in Patients With Mastectomy Surgery According to Apfel Risk Scoring System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cukurova University

Adana, 01130, Turkey (Türkiye)

About this study

METHODOLOGY This descriptive, cross-sectional study was conducted at Department of Surgical Oncology of a tertiary care hospital between June 2020 and August 2020. The study centre has a 1,200-bed capacity and the surgical oncology clinic has a 30-bed capacity. A total of 57 women who were scheduled for elective mastectomy for breast cancer were included. Inclusion criteria were as follows: women aged ≥18 years, hospitalization 6 hours prior to surgery, American Society of Anesthesiologists (ASA) Class I-III, having no chronic pain or alcohol and/or substance abuse, having no cognitive impairment, no need for mechanical ventilation, having a confirmed diagnosis of breast cancer, and being scheduled for mastectomy. Prior to study, all patients were informed about the nature of the study and a written informed consent was obtained. The study protocol was approved by the institutional Non-Interventional Clinical Research Ethics Committee (No: 15.05.2020/99). The study was conducted in accordance with the principles of the Declaration of Helsinki.

Preoperative and postoperative data within 48 hours were collected via face-to-face interviews. The Patient Assessment Form, which was developed in accordance with the previous studies in the literature, was used to collect data including age and body mass index (BMI) pre- and postoperatively. For the postoperative evaluation, the four-item, simplified Apfel Risk Scoring System was used. It is a valid tool which assesses PONV and/or motion sickness, non-smoking status, and postoperative use of opioids. Accordingly, 0-1 indicate low, 2 indicate moderate, and ≥3-4 indicate high risk for PONV [12]. In our study, PONV was evaluated using the Patient Assessment Form at 0, 2, 4, 8, 24, and 48 hours as "Yes/No" scoring.

Statistical analysis was performed using the SPSS version 22.0 software (IBM Corp., Armonk, NY, USA). Descriptive data were expressed in mean ± standard deviation (SD), median (min-max) or number and frequency, where applicable. The chi-square test was used to evaluate relationship between categorical variables. The Mann-Whitney U test (Z table values) was performed to compare two independent groups which did not meet the normal distribution. The continuity correction and Fisher exact test were used to examine the relationship between two quantitative variables. The independent samples t-test (t table values) was used to compare two independent groups which met the normal distribution. A p value of <0.05 was considered statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Evaluation of the Apfel risk score before surgery

    Time frame: Preoperative 0-1 days

    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.

Secondary outcomes

  1. Evaluation of postoperative nausea and vomiting

    Time frame: Postoperative 0-2 days

    Using the Patient Evaluation Form, the patient's nausea and vomiting at 0, 2, 4, 8, 24 and 48 hours after the surgery was evaluated as "Yes/No" scoring.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Cukurova University

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.