NCT05798000

Brief Summary

The study to investigate the effectiveness and the current perception of safety checklists in Ukrainian hospitals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 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

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 22, 2023

Last Update Submit

March 22, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recorded critical incidents during the procedure

    Recorded critical incidents during the procedure (hypotension, hypertension etc.)

    24 hours

  • Mortality

    Postoperative mortality during 28 days after surgery

    28 days

Secondary Outcomes (1)

  • Postoperative complications

    1 months

Study Arms (2)

Control

The control group without WHO and equipment checklist used

Study

Other group, where WHO safety check-list and equipment check-list were implemented

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Institutions, where surgical department administration was willing to implement the Safe Surgery Saves Lives campaign recommendations but has not yet formally introduced the WHO Safe Surgery Checklist.

You may qualify if:

  • medical institutions with surgical departments

You may not qualify if:

  • medical institutions without surgical departments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bogomolets NMU

Kyiv, Ukraine

Location

Related Publications (3)

  • Schwendimann R, Blatter C, Luthy M, Mohr G, Girard T, Batzer S, Davis E, Hoffmann H. Adherence to the WHO surgical safety checklist: an observational study in a Swiss academic center. Patient Saf Surg. 2019 Mar 12;13:14. doi: 10.1186/s13037-019-0194-4. eCollection 2019.

    PMID: 30918531BACKGROUND
  • Sendlhofer G, Mosbacher N, Karina L, Kober B, Jantscher L, Berghold A, Pregartner G, Brunner G, Kamolz LP. Implementation of a surgical safety checklist: interventions to optimize the process and hints to increase compliance. PLoS One. 2015 Feb 6;10(2):e0116926. doi: 10.1371/journal.pone.0116926. eCollection 2015.

    PMID: 25658317BACKGROUND
  • Bergs J, Hellings J, Cleemput I, Zurel O, De Troyer V, Van Hiel M, Demeere JL, Claeys D, Vandijck D. Systematic review and meta-analysis of the effect of the World Health Organization surgical safety checklist on postoperative complications. Br J Surg. 2014 Feb;101(3):150-8. doi: 10.1002/bjs.9381.

    PMID: 24469615BACKGROUND

Study Officials

  • Kateryna Bielka, PhD

    Bogomolets National Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 4, 2023

Study Start

February 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations