NCT02646345

Brief Summary

Limited information is available about surgical checklist effectiveness in Latin America. We plan to compare the pre and post surgical checklist implementation in a tertiary healthcare center in terms of morbidity (length of stay and surgical site infection rate) and in-hospital mortality rate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70,639

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

January 5, 2016

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

December 28, 2015

Last Update Submit

December 31, 2015

Conditions

External Causes of Morbidity and MortalityExternal Causes of Morbidity (V00-Y99)

Keywords

ChecklistMortalityLatin AmericaSurgeryMorbidity

Outcome Measures

Primary Outcomes (1)

  • Mortality

    30 day postoperative mortality

    Three years

Secondary Outcomes (2)

  • Morbidity

    Three years

  • Length of stay

    Three years

Study Arms (2)

Pre Checklist

All surgical encounters before surgical checklist implementation

Post Checklist

All surgical encounters after surgical checklist implementation

Procedure: Surgical checklist

Interventions

Surgical checklistPROCEDURE

Use of the World Health Organization Surgical checklist

Post Checklist

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All surgical patients age 15 and above

You may qualify if:

  • All surgical patients

You may not qualify if:

  • Obstetrical patients delivering vaginally
  • Patients less than 15 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.

    PMID: 19144931BACKGROUND

  • de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008 Jun;17(3):216-23. doi: 10.1136/qshc.2007.023622.

    PMID: 18519629BACKGROUND

  • Tscholl DW, Weiss M, Kolbe M, Staender S, Seifert B, Landert D, Grande B, Spahn DR, Noethiger CB. An Anesthesia Preinduction Checklist to Improve Information Exchange, Knowledge of Critical Information, Perception of Safety, and Possibly Perception of Teamwork in Anesthesia Teams. Anesth Analg. 2015 Oct;121(4):948-956. doi: 10.1213/ANE.0000000000000671.

    PMID: 25806399BACKGROUND

  • Schwarze ML, Barnato AE, Rathouz PJ, Zhao Q, Neuman HB, Winslow ER, Kennedy GD, Hu YY, Dodgion CM, Kwok AC, Greenberg CC. Development of a list of high-risk operations for patients 65 years and older. JAMA Surg. 2015 Apr;150(4):325-31. doi: 10.1001/jamasurg.2014.1819.

    PMID: 25692282BACKGROUND

  • Wachtel RE, Dexter F. Differentiating among hospitals performing physiologically complex operative procedures in the elderly. Anesthesiology. 2004 Jun;100(6):1552-61. doi: 10.1097/00000542-200406000-00031.

    PMID: 15166578BACKGROUND

  • Urbach DR, Govindarajan A, Saskin R, Wilton AS, Baxter NN. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med. 2014 Mar 13;370(11):1029-38. doi: 10.1056/NEJMsa1308261.

    PMID: 24620866BACKGROUND

  • de Vries EN, Prins HA, Crolla RM, den Outer AJ, van Andel G, van Helden SH, Schlack WS, van Putten MA, Gouma DJ, Dijkgraaf MG, Smorenburg SM, Boermeester MA; SURPASS Collaborative Group. Effect of a comprehensive surgical safety system on patient outcomes. N Engl J Med. 2010 Nov 11;363(20):1928-37. doi: 10.1056/NEJMsa0911535.

    PMID: 21067384BACKGROUND

  • Calland JF, Turrentine FE, Guerlain S, Bovbjerg V, Poole GR, Lebeau K, Peugh J, Adams RB. The surgical safety checklist: lessons learned during implementation. Am Surg. 2011 Sep;77(9):1131-7.

    PMID: 21944620BACKGROUND

  • Leape LL. The checklist conundrum. N Engl J Med. 2014 Mar 13;370(11):1063-4. doi: 10.1056/NEJMe1315851. No abstract available.

    PMID: 24620871BACKGROUND

  • Conley DM, Singer SJ, Edmondson L, Berry WR, Gawande AA. Effective surgical safety checklist implementation. J Am Coll Surg. 2011 May;212(5):873-9. doi: 10.1016/j.jamcollsurg.2011.01.052. Epub 2011 Mar 12.

    PMID: 21398154BACKGROUND

Study Officials

  • Hector J Lacassie, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 5, 2016

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

January 5, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share