Incidence and Risk Factors of Chronic (Persistant) Post-surgical Pain in Oncological Breast Surgery : a Prospective Cohort Study in a National Institute of Oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 722
- 试验地点
- 2
- 主要终点
- Post-mastectomy pain
研究概览
简要总结
Post Mastectomy Pain Syndrome (PMPS) is a major complication of breast surgery responsible for depression and disability.
The project consists of a prospective cohort on patients going for oncological breast surgery at National Institute of Oncology of Rabat.
Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem, which could last for more than 3 months after surgery. The aim of present study was to assess the prevalence of CPP, investigate its impact on life quality and explore its potential risk factors. After informed consent was signed, patients receiving surgery under general anesthesia in Peking Union Medical College Hospital and other medical centers participating in this study during 2018 will be included. Patients' preoperative information will be collected from medical record, including basic demographic data, primary disease and previous chronic diseases. Intraoperative information will be obtained from anesthesia record, including surgical scope, duration, length and location of incisions and blood loss. Acute pain will be evaluated in the ward of the department of surgery, when an app will be installed on patients' mobile phones. Our long-term postoperative follow-up would be performed by sending out survey questionnaires via this app in the 4th, 8th, 16th, 32th, and 48th weeks after surgery. The survey covers questions regarding the intensity, characteristic, location and impact on daily activities of CPP. Information regarding treatment of CPP will also be collected, if any. All the data gained will be summarized in our database and analyzed.
详细描述
Type of work: This is an observational, prospective, open, data-driven, single-center study at the National Institute of Oncology (NIO) - Mohamed Ben Abdellah Hospital in Rabat, affiliated to Mohammed V University in Rabat.
The objective of the study we are proposing is to determine the incidence and risk factors of chronic post-surgical pain in oncological breast surgery on the Moroccan population operated on and followed at the Sheikha Fatma Center of the National Institute of 'Oncology of Rabat.
The main objective of the study is to:
- Determine the incidence of chronic post-surgical pain in carcinological breast surgery
The secondary objectives are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Willingness and ability to sign an informed consent document
- •More than 18 years of age
- •All American Society of Anesthesiology classes
- •Patient undergo for breast surgery
排除标准
- •Patients who expressed their refusal to participate in the study
- •Patients unable to express their non-opposition to participating in the study
结局指标
主要结局
Post-mastectomy pain
时间窗: preoperative-3months postoperative
Assessed via breast pain questionnaire, including severity, frequency, related symptoms, and functional impairment
次要结局
未报告次要终点
研究者
Amine Souadka
Principal Investigator
Moroccan Society of Surgery