Postoperative ComplicationsNCT02947789
Predictive Model for Postoperative Mortality
An observational study of Postoperative Complications, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Emergency surgery
- Type of treatment
- Surgery or procedure
- How many people
- 740 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing emergency surgery
Who may be able to join
- Emergency surgery
- Age => 18 years
Who cannot join
- Caesarean section
- Incomplete medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Model for Postoperative Mortality in Adult Emergency Surgical Patients Under General Anesthesia
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.
Read the detailed description
Objective: To identify risk factors for postoperative mortality within 3 days in adult patients undergoing emergency surgery and construct a predictive model.
Methods: This will be a retrospective, exploratory and analytical study. All medical records of adult patients undergoing emergency surgery between January 2013 to December 2014 will be used to analyze for relevant risk factors using binary logistic regression analysis. A predictive model to predict postoperative morbidity within 3 days will be constructed.
- Conditions
- Postoperative Complications
- Being tested
- Emergency surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency surgeryProcedure or surgery
Patients undergoing emergency surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Emergency surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mortality within 3 days
Patient die postoperatively within 3 day3
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Sirirat Tribuddharat, MD, Principal investigator, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947789
- Sponsor's protocol ID
- HE581131
- Status last verified
- May 2017
- First submitted
- 26 Oct 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21421099Fukuda 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.
PubMed 22578159Ingraham 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.
PubMed 20633727Matsuyama 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.
PubMed 23700220Wilson 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.
PubMed 25229887
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Model for Postoperative Mortality in Adult Emergency Surgical Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT02947789
- Acronym / sponsor ID
- HE581131
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: To identify risk factors for postoperative mortality within 3 days in adult patients undergoing emergency surgery and construct a predictive model.
Methods: This will be a retrospective, exploratory and analytical study. All medical records of adult patients undergoing emergency surgery between January 2013 to December 2014 will be used to analyze for relevant risk factors using binary logistic regression analysis. A predictive model to predict postoperative morbidity within 3 days will be constructed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative mortality within 3 days | – | Procedure: Emergency surgeryGroup 1: Patients undergoing emergency surgery with postoperative mortality within 3 days Group 2: Patients undergoing emergency surgery without postoperative mortality within 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing emergency surgery
Key inclusion criteria (2 listed)
- Emergency surgery
- Age => 18 years
Key exclusion criteria (2 listed)
- Caesarean section
- Incomplete medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency surgeryPatients undergoing emergency surgery | Procedure or surgery | Postoperative mortality within 3 days |
Primary outcome
Postoperative mortality within 3 days
Time frame: through study completion, an average of 1 week
Patient die postoperatively within 3 day3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Results publication: PubMed 21421099Akinbami 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.
- Results publication: PubMed 22578159Fukuda 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.
- Results publication: PubMed 20633727Ingraham 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.
- Results publication: PubMed 23700220Matsuyama 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.
- Results publication: PubMed 25229887Wilson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirirat Tribuddharat, MD principal investigator
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative mortality within 3 days (time frame: through study completion, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947789, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.