NCT02947789

Brief Summary

Surgery has risk of morbidity and mortality. Risk factors include: patient factors; surgical factors; and anesthetic factors. The risk is much higher in emergency cases. The study of relevant risk factors can lead to improvement in patient management and reduction in mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
740

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

October 26, 2016

Last Update Submit

May 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative mortality within 3 days

    Patient die postoperatively within 3 day3

    through study completion, an average of 1 week

Study Arms (1)

Postoperative mortality within 3 days

Group 1: Patients undergoing emergency surgery with postoperative mortality within 3 days Group 2: Patients undergoing emergency surgery without postoperative mortality within 3 days

Procedure: Emergency surgery

Interventions

Patients undergoing emergency surgery

Postoperative mortality within 3 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing emergency surgery

You may qualify if:

  • Emergency surgery
  • Age =\> 18 years

You may not qualify if:

  • Caesarean section
  • Incomplete medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (5)

  • Akinbami F, Askari R, Steinberg J, Panizales M, Rogers SO Jr. Factors affecting morbidity in emergency general surgery. Am J Surg. 2011 Apr;201(4):456-62. doi: 10.1016/j.amjsurg.2010.11.007.

  • Fukuda N, Wada J, Niki M, Sugiyama Y, Mushiake H. Factors predicting mortality in emergency abdominal surgery in the elderly. World J Emerg Surg. 2012 May 11;7(1):12. doi: 10.1186/1749-7922-7-12.

  • Ingraham AM, Cohen ME, Bilimoria KY, Raval MV, Ko CY, Nathens AB, Hall BL. Comparison of 30-day outcomes after emergency general surgery procedures: potential for targeted improvement. Surgery. 2010 Aug;148(2):217-38. doi: 10.1016/j.surg.2010.05.009.

  • Matsuyama T, Iranami H, Fujii K, Inoue M, Nakagawa R, Kawashima K. Risk factors for postoperative mortality and morbidities in emergency surgeries. J Anesth. 2013 Dec;27(6):838-43. doi: 10.1007/s00540-013-1639-z. Epub 2013 May 23.

  • Wilson I, Paul Barrett M, Sinha A, Chan S. Predictors of in-hospital mortality amongst octogenarians undergoing emergency general surgery: a retrospective cohort study. Int J Surg. 2014 Nov;12(11):1157-61. doi: 10.1016/j.ijsu.2014.08.404. Epub 2014 Sep 16.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sirirat Tribuddharat, MD

    Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 11, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations