The Nigerian Surgical Outcomes Study. This Study is Aimed at Observing for Complications Within 30 Days After Surgery
NCT ID: NCT03551912
Last Updated: 2018-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2018-06-30
2018-08-12
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Surgery
All patients coming for elective surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University of Ibadan
OTHER
Responsible Party
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Babatunde Osinaike
Reader
Principal Investigators
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Babatunde Babatunde, MBChB,FMCA
Role: PRINCIPAL_INVESTIGATOR
University of Ibadan/University College Hospital
Locations
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University College Hospital
Ibadan, Oyo State, Nigeria
Countries
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Central Contacts
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Facility Contacts
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References
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Biccard BM, Madiba TE, Kluyts HL, Munlemvo DM, Madzimbamuto FD, Basenero A, Gordon CS, Youssouf C, Rakotoarison SR, Gobin V, Samateh AL, Sani CM, Omigbodun AO, Amanor-Boadu SD, Tumukunde JT, Esterhuizen TM, Manach YL, Forget P, Elkhogia AM, Mehyaoui RM, Zoumeno E, Ndayisaba G, Ndasi H, Ndonga AKN, Ngumi ZWW, Patel UP, Ashebir DZ, Antwi-Kusi AAK, Mbwele B, Sama HD, Elfiky M, Fawzy MA, Pearse RM; African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018 Apr 21;391(10130):1589-1598. doi: 10.1016/S0140-6736(18)30001-1. Epub 2018 Jan 3.
International Surgical Outcomes Study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016 Oct 31;117(5):601-609. doi: 10.1093/bja/aew316.
Other Identifiers
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NHREC/01/01/2007
Identifier Type: -
Identifier Source: org_study_id
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