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临床试验/NCT04986722
NCT04986722已完成不适用

Cukurova University

Cukurova University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Evaluation of the Apfel risk score before surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Evaluation of the Apfel risk score before surgery

时间窗: 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.

次要结局

  • Evaluation of postoperative nausea and vomiting(Postoperative 0-2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hamide Sisman

Principal Investigator

Cukurova University

研究点 (1)

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