NCT03551912

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: University of Ibadan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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. * 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.

Conditions

• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Surgery	All patients coming for elective surgery

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-06-14
• Completion: 2018-08-12
• First posted: 2018-06-11
• Last updated: 2018-06-11

Locations

1 site across 1 country: Nigeria