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

NCT ID: NCT03551912

Last Updated: 2018-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-30

Study Completion Date

2018-08-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Surgery

All patients coming for elective surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ibadan

OTHER

Sponsor Role lead

Responsible Party

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Babatunde Osinaike

Reader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Babatunde Babatunde, MBChB,FMCA

Role: PRINCIPAL_INVESTIGATOR

University of Ibadan/University College Hospital

Locations

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University College Hospital

Ibadan, Oyo State, Nigeria

Site Status

Countries

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Nigeria

Central Contacts

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Babatunde Osinaike, MBChB,FMCA

Role: CONTACT

+2348033303675

Bolaji Oyedepo, OND

Role: CONTACT

+2349033058747

Facility Contacts

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Babatunde Osinaike, MBChB, FMCA

Role: primary

+2348033303675

Olusola Idowu, MBChB,FWACS

Role: backup

+2348053136030

References

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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.

Reference Type RESULT
PMID: 29306587 (View on PubMed)

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.

Reference Type RESULT
PMID: 27799174 (View on PubMed)

Other Identifiers

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NHREC/01/01/2007

Identifier Type: -

Identifier Source: org_study_id

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