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

Postoperative Complications Clinical Trial

— NiSOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03551912
• Other study ID #: NHREC/01/01/2007
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Postoperative Complications

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