Postoperative Complications Clinical Trial
— NiSOSOfficial title:
Nigerian Surgical Outcomes Study. A Nigerian, Multi-centre Seven-day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery
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.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | August 12, 2018 |
Est. primary completion date | June 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Nigeria | University College Hospital | Ibadan | Oyo |
Lead Sponsor | Collaborator |
---|---|
University of Ibadan |
Nigeria,
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, Z — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative complications | In-hospital post-operative complications of any cause | At discharge or 30 days, whichever is earlier. | |
Secondary | Mortality | Rate of mortality on the day of surgery | Within 24 hours | |
Secondary | Mortality | In-hospital all-cause mortality | At 30 days after surgery | |
Secondary | Critical care admission | Critical care admission after surgery | At 30 days after surgery | |
Secondary | Duration of hospital stay | Duration of hospital stay after surgery | At discharge or 30 days |
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