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

NCT03551912 | Unknown DMC

• 1 other identifier: NHREC/01/01/2007
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Post-operative complications

  In-hospital post-operative complications of any cause

  At discharge or 30 days, whichever is earlier.

Secondary Outcomes (4)

• Mortality

  Within 24 hours

• Mortality

  At 30 days after surgery

• Critical care admission

  At 30 days after surgery

• Duration of hospital stay

  At discharge or 30 days

Interventions

Surgery PROCEDURE

All patients coming for elective surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults or Paediatrics coming for elective surgical procedures

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Ibadan: lead

Study Sites (1)

University College Hospital

Ibadan, Oyo State, 2340001, Nigeria

Location

Related 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, 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.

  PMID: 29306587 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.

  PMID: 27799174 RESULT

MeSH Terms

Conditions

Postoperative Complications

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Babatunde Babatunde, MBChB,FMCA

  University of Ibadan/University College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Babatunde Osinaike, MBChB,FMCA

CONTACT

+2348033303675; drosinaike@yahoo.co.uk

Bolaji Oyedepo, OND

CONTACT

+2349033058747; blykid1993@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 11, 2018
• Study Start: June 1, 2018
• Primary Completion: June 14, 2018
• Study Completion: August 12, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)