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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.
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | All patients coming for elective surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative complications | In-hospital post-operative complications of any cause | At discharge or 30 days, whichever is earlier. |
| 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 |
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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.
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Adults or Paediatrics coming for elective surgical procedures
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Babatunde Osinaike, MBChB,FMCA | Contact | +2348033303675 | drosinaike@yahoo.co.uk | |
| Bolaji Oyedepo, OND | Contact | +2349033058747 | blykid1993@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Babatunde Babatunde, MBChB,FMCA | University of Ibadan/University College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Hospital | Ibadan | Oyo State | 2340001 | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29306587 | Result | 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. | |
| 27799174 |
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Data will be pseudo-anonymised by generation of a unique numeric code and transcribed by local investigators onto an internet based electronic CRF. Each patient will only be identified on the electronic CRF by their numeric code; thus the co- ordinating study team cannot trace data back to an individual patient without contact with the local team.
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 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 |
| Result |
| 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. |