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临床试验/NCT03551912
NCT03551912Unknown不适用

Nigerian Surgical Outcomes Study. A Nigerian, Multi-centre Seven-day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery

University of Ibadan1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2018年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,000
试验地点
1
主要终点
Post-operative complications

研究概览

简要总结

The Nigerian Surgical Outcome Study is a national 30-day observational cohort study of complications after surgery. Various institutions across Nigeria will be involved. The study aims at providing detailed data describing post-operative complications, requirement for intensive care and mortality. All patients undergoing either elective surgery during a 7-day study period with a planned overnight stay will be recruited.

详细描述

It is widely known that complications after surgery are responsible for a good number of morbidity and mortality following surgery. This national cohort study will help contribute to, and allow a better computation of data on post-operative complications and mortality following elective surgery in Nigeria.

This study therefore has important public health implications for Nigeria. This study will also provide a baseline for other similar studies in future being the first of such in Nigeria.

Objectives are:

  1. To determine the mortality rate on the day of surgery for patients undergoing surgery in Nigeria.
  2. To determine the in-hospital mortality rate for patients undergoing surgery in Nigeria.
  3. To describe the relationship between anaesthetic complications and postoperative mortality.
  4. To describe the relationship between postoperative complications and postoperative mortality.
  5. To describe the proportional contribution of communicable, non-communicable diseases and traumatic injuries to critical care admissions and in-hospital mortality in Nigeria. We plan to recruit a minimum of 5 centres per state, made up of federal, state and private hospitals. The national coordinating centre shall be the University College Hospital, Ibadan. Regional coordinating centres shall be in Lagos, Kwara, Enugu, Kaduna, Port-Harcourt, Maiduguri and Abuja.The plan is to recruit all eligible patients during the recruitment week.

All recruited patients would have had the routine preoperative surgical and anaesthetic review. Since the study is purely observational, all basic intraoperative procedures as it relates to surgery and anaesthesia will not be altered. Following informed written consent by the patient, the following information will be obtained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All consecutive patients admitted to participating centres undergoing elective surgery with a planned overnight hospital stay following surgery during a seven-day study period. The recruitment week will run between June and July 2018.

排除标准

  • Patients undergoing planned day-case surgery or procedures outside the operating theatre.

结局指标

主要结局

Post-operative complications

时间窗: At discharge or 30 days, whichever is earlier.

In-hospital post-operative complications of any cause

次要结局

  • Mortality(At 30 days after surgery)
  • Duration of hospital stay(At discharge or 30 days)
  • Critical care admission(At 30 days after surgery)

研究者

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

Babatunde Osinaike

Reader

University of Ibadan

研究点 (1)

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