The Nigerian Surgical Outcomes Study. This Study is Aimed at Observing for Complications Within 30 Days After Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To determine the mortality rate on the day of surgery for patients undergoing surgery in Nigeria. To determine the in-hospital mortality rate for patients undergoing surgery in Nigeria. To describe the relationship between anaesthetic complications and postoperative mortality. To describe the relationship between postoperative complications and postoperative mortality. 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. Results of preoperative Haemoglobin, Total white cell count, and Creatinine. Patient's socio-demographics. Co-morbid conditions Type of anaesthesia and surgical procedure. Anaesthetic and Surgical details Critical care admission post-operatively, and Postoperative complications observed till discharge or up to 30 days if on admission.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients undergoing planned day-case surgery or procedures outside the operating theatre.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Surgery|All patients coming for elective surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | In-hospital post-operative complications of any cause | At discharge or 30 days, whichever is earlier. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of mortality on the day of surgery | Within 24 hours | 
| Mortality | In-hospital all-cause mortality | At 30 days after surgery | 
| Critical care admission | Critical care admission after surgery | At 30 days after surgery | 
| Duration of hospital stay | Duration of hospital stay after surgery | At discharge or 30 days |