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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03551912
Other study ID # NHREC/01/01/2007
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2018
Est. completion date August 12, 2018

Study information

Verified date June 2018
Source University of Ibadan
Contact Babatunde Osinaike, MBChB,FMCA
Phone +2348033303675
Email drosinaike@yahoo.co.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery
All patients coming for elective surgery

Locations

Country Name City State
Nigeria University College Hospital Ibadan Oyo

Sponsors (1)

Lead Sponsor Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

References & Publications (2)

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

Outcome

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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