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Status unknownNCT03551912NiSOSUpdated Jun 11, 2018

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

An observational study in Postoperative Complications, sponsored by University of Ibadan. Status unknown at 1 site in Nigeria. Per ClinicalTrials.gov, last updated 2018-06-11.

Sponsored by University of Ibadan · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Sex
All
01

Study 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.

Read the detailed 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.
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Conditions studied

  • Postoperative Complications
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In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

University of Ibadan is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults or Paediatrics coming for elective surgical procedures

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

Exclusion Criteria:

Patients undergoing planned day-case surgery or procedures outside the operating theatre.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Interventions

  • ProcedureSurgery

    All patients coming for elective surgery

06

What researchers measure

Primary outcomes

  1. Post-operative complications

    In-hospital post-operative complications of any cause

    Time frame: At discharge or 30 days, whichever is earlier.

Secondary outcomes

  1. Mortality

    Rate of mortality on the day of surgery

    Time frame: Within 24 hours

  2. Mortality

    In-hospital all-cause mortality

    Time frame: At 30 days after surgery

  3. Critical care admission

    Critical care admission after surgery

    Time frame: At 30 days after surgery

  4. Duration of hospital stay

    Duration of hospital stay after surgery

    Time frame: At discharge or 30 days

07

Study locations

1 site
  • University College Hospital
    Ibadan, Oyo 2340001, Nigeria
08

References and documents

Publications

  • 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. PubMed 29306587 ↗
  • 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. Erratum In: Br J Anaesth. 2017 Sep 1;119(3):553. doi: 10.1093/bja/aew472. PubMed 27799174 ↗

Individual participant data

Plan to share: No — 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03551912
Lead sponsor
University of Ibadan
Responsible party
Babatunde Osinaike (Reader, University of Ibadan) — Principal investigator
First posted
Jun 11, 2018
Start date
Jun 2018 (estimated)
Primary completion
Jun 14, 2018 (estimated)
Completion
Aug 12, 2018 (estimated)
Last update
Jun 11, 2018

Study contacts

Babatunde Osinaike, MBChB,FMCA
Contact
drosinaike@yahoo.co.uk
+2348033303675
Bolaji Oyedepo, OND
Contact
blykid1993@yahoo.com
+2349033058747
Babatunde Babatunde, MBChB,FMCA
principal investigator · University of Ibadan/University College Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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