NCT04487496

Brief Summary

Access to surgery is reported to be significantly lower in low income countries like Nigeria, and upwards of 5 billion people globally lack safe access to surgery. The investigators intend to answer the question, what is the burden of access to acute care surgery alongside their determinants in the University College Hospital, Ibadan (UCH). The expected results from this study will provide basis for evidence-based policy aimed at improving time-to-emergency surgery and thus improve outcomes. A cross-sectional doctors' survey and a prospective case records review would be the study designs; using a minimum of fifty-one participants and case records respectively. The doctors will be selected randomly from all the surgical services and the emergency department in the UCH, ensuring a fairly equal allocation. The case notes will be of patients in the UCH requiring emergency surgery that had surgeries. Data from this study will be entered and analysed using STATA/MP 15.0 (Stata Corp, College station, TX).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

June 22, 2020

Last Update Submit

May 11, 2023

Conditions

Keywords

Emergency surgeryAccess to emergency surgeryAcute surgical careAcute trauma care

Outcome Measures

Primary Outcomes (2)

  • Time-to-surgery

    This will collect information about the time from specific event (onset of symptoms, entry into the hospital, diagnosis and decision for surgical care) to the actual onset of the emergency surgery

    One year

  • Factors affecting onset of emergency surgery

    This will gather from the doctors' survey and the prospective case records review, the patient related, healthcare giver related and institutional related determinants of access to emergency surgery

    One year

Secondary Outcomes (1)

  • Post-operative outcome

    One year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This shall comprise all the healthcare givers related to the surgical specialties in UCH, these include the following departments: surgery, plastics and reconstructive and aesthetic surgery, neurological surgery, orthopaedics and trauma, otorhinolaryngology, ophthalmology, obstetrics and gynaecology, oral and maxillofacial surgery, anaesthesia as well as the accident and emergency. The case-records of all patients presenting through the emergency room of University College Hospital Ibadan, requiring emergency surgery as determined by the surgical services.

You may qualify if:

  • All recruited doctors who give consent
  • All eligible case records of surgical emergencies determined by the surgical services.

You may not qualify if:

  • Case records of patients to be directly managed by the principal investigator
  • Case records of patients who die before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital

Ibadan, Oyo State, 5116, Nigeria

Location

Related Publications (8)

  • Carr BG, Bowman AJ, Wolff CS, Mullen MT, Holena DN, Branas CC, Wiebe DJ. Disparities in access to trauma care in the United States: A population-based analysis. Injury. 2017 Feb;48(2):332-338. doi: 10.1016/j.injury.2017.01.008. Epub 2017 Jan 3.

    PMID: 28069138BACKGROUND
  • Chawla KS, Rutkow L, Garber K, Kushner AL, Stewart BT. Beyond a Moral Obligation: A Legal Framework for Emergency and Essential Surgical Care and Anesthesia. World J Surg. 2017 May;41(5):1208-1217. doi: 10.1007/s00268-016-3866-6.

    PMID: 28180984BACKGROUND
  • Gani F, Sakran JV, Canner JK. Emergency Department Visits For Firearm-Related Injuries In The United States, 2006-14. Health Aff (Millwood). 2017 Oct 1;36(10):1729-1738. doi: 10.1377/hlthaff.2017.0625.

    PMID: 28971917BACKGROUND
  • MC, R. (1991). An in-vivo of the microbial proliferation beneath transport film dressings in: Maki DG, ed, International congress and symposium series No 179, improving catheter site care. London Series (pp. 29-33). London: Royal Society of Medicine.

    BACKGROUND
  • Scott JW, Havens JM, Wolf LL, Zogg CK, Rose JA, Salim A, Haider AH. Insurance status is associated with complex presentation among emergency general surgery patients. Surgery. 2017 Feb;161(2):320-328. doi: 10.1016/j.surg.2016.08.038. Epub 2016 Oct 4.

    PMID: 27712875BACKGROUND
  • Solomon, L., Warwick, D., & Nayagam, S. (2010). Apley's System of Orthopaedics and Fractures. London: Hodder Arnold.

    BACKGROUND
  • Watters DA, Guest GD, Tangi V, Shrime MG, Meara JG. Global Surgery System Strengthening: It Is All About the Right Metrics. Anesth Analg. 2018 Apr;126(4):1329-1339. doi: 10.1213/ANE.0000000000002771.

    PMID: 29547428BACKGROUND
  • World health statistics 2019: monitoring health for the SDGs, sustainable development goals. Licence: CC BY-NC-SA 3.0 IGO. (2019). Geneva: World Health Organization. Retrieved August 15, 2019, from https://www.who.int/gho/publications/world_health_statistics/2019/EN_WHS_2019_Main.pdf?ua=1

    BACKGROUND

Study Officials

  • Promise T Jaja, MB;BS, MSc

    University College Hospital, Ibadan

    PRINCIPAL INVESTIGATOR
  • Adefemi O Afolabi, MB;BS, FWACS

    University College Hospital, Ibadan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 27, 2020

Study Start

August 17, 2020

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

The de-identified data set will be developed and presented in a share-able format and most likely deposited in an online data repository

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data will be available within two years of the final completion of the study
Access Criteria
Access will be granted following a review of written requests for the data

Locations