Chronic Postoperative PainNCT02190682
Data Collection for Prediction of Postoperative Chronic Pain for a Software
An observational study of Chronic Postoperative Pain, run by Istanbul University at 6 sites in Turkey (Türkiye).
Trial summary
Postoperative Persistent Pain (PPP) is reported with a high incidence in adults 11.5-47%. This high incidence effects quality of life of patients causes social-economical problems and arises medico-legal issues. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Postoperative Pain
- How many people
- 733 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- Oct 2014to 30 Apr 2018
- How long will I take part?
- 4 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all cases undergoing surgery
Who may be able to join
- all cases operated in one month period
Who cannot join
- cases who cannot be followed for 2 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34303
Bezm-i Alem University
Istanbul
Istanbul Research and Training Hospital
Istanbul
Istanbul University Cardiology Institute
Istanbul
Istanbul University Informatics Department
Istanbul
Tepecik Research and Training Hospital
Izmir
About this study
Official title: Data Collection for Prediction of Postoperative Chronic Pain for Establishing a Software by Using Data Mining Technology
Postoperative Persistent Pain (PPP) is reported with a high incidence in adults 11.5-47%. This high incidence effects quality of life of patients causes social-economical problems and arises medico-legal issues. This study will be undertaken for producing a database by the evaluation of surgeries in 4 hospitals located in Istanbul. This database will be used in establishing a software by using data mining technology in the prediction of PPP
Read the detailed description
All cases operated in 4 different hospitals in one month period will be included Exclusion criteria: cases who could not be followed up to 2 months postoperatively by telephone call.
A questionnaire will be filled preoperatively for each case after obtaining informed case . All cases will be anesthetized and pain therapy will be applied according to anesthesiologist's own practice and pain relief will be evaluated and noted. All patients will be telephoned postoperatively for the pain level at 15,30,45 and 60th day. All the information will be uploaded to computer and a software will be prepared for prediction of postoperative chronic pain.
- Conditions
- Chronic Postoperative Pain
- Keywords
- postoperative, chronic, pain, software
- Medical subject headings
- Pain, Postoperative, Bronchiolitis Obliterans Syndrome, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative chronic pain
Postoperative chronic pain is pain in the area of surgery lasting at least 2 months postoperatively regardless of infection, recurrence of disease and etc.
Measured: postoperative 3 months
Secondary outcomes (1)
preparation of software for the prediction of postoperative chronic pain
the information from the questioners to the patients will be uploaded to an excel sheet and the IT group will prepare a software by using the data mining technology
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 733 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Prof. Dr. A. Pervin SUTAS BOZKURT, Istanbul University
- Investigators
- Pervin Bozkurt Sutaş, Prof. Dr, Study director, Istanbul University Cerrahpaşa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190682
- Sponsor's protocol ID
- 2062014
- Status last verified
- Jan 2020
- First submitted
- 12 Jul 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Patient questioner
Publications
Sutaş Bozkurt, A. P., Özen, Z., Kartal, E., Emre, İ. E., Selçukcan Erol, Ç., Koçoğlu, F. Ö., Güngör, G., Güneyli, H. C., Başaranoğlu, G., Ünlüsoy, E. Ö., Uğur, H. Ö., Buluç Bulğen, S., Çolakoğlu, N., Sayılgan, C., Pekel, A. F., Pişmişoğlu, H., Salihoğlu, Z., Yüceyar, L., Karaca, S., … Bakan, N. (2018). Analysis of the incidence and predictive factors of chronic postoperative pain in adult population. The Journal of Tepecik Education and Research, 28(2), 89-94. https://doi.org/10.5222/terh.2018.089
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for Prediction of Postoperative Chronic Pain for Establishing a Software by Using Data Mining Technology
- ClinicalTrials.gov ID
- NCT02190682
- Acronym / sponsor ID
- 2062014
- Conditions
- Chronic Postoperative Pain
- Keywords
- postoperative, chronic, pain, software
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 15 Jul 2014 (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.
Postoperative Persistent Pain (PPP) is reported with a high incidence in adults 11.5-47%. This high incidence effects quality of life of patients causes social-economical problems and arises medico-legal issues. This study will be undertaken for producing a database by the evaluation of surgeries in 4 hospitals located in Istanbul. This database will be used in establishing a software by using data mining technology in the prediction of PPP
Detailed description
All cases operated in 4 different hospitals in one month period will be included Exclusion criteria: cases who could not be followed up to 2 months postoperatively by telephone call.
A questionnaire will be filled preoperatively for each case after obtaining informed case . All cases will be anesthetized and pain therapy will be applied according to anesthesiologist's own practice and pain relief will be evaluated and noted. All patients will be telephoned postoperatively for the pain level at 15,30,45 and 60th day. All the information will be uploaded to computer and a software will be prepared for prediction of postoperative chronic pain.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all cases undergoing surgery
Key inclusion criteria (1 listed)
- all cases operated in one month period
Key exclusion criteria (1 listed)
- cases who cannot be followed for 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative chronic pain
Time frame: postoperative 3 months
Postoperative chronic pain is pain in the area of surgery lasting at least 2 months postoperatively regardless of infection, recurrence of disease and etc.
1 secondary outcome
preparation of software for the prediction of postoperative chronic pain
Time frame: 8 months
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 27 Jan 2020.
- BackgroundSutaş Bozkurt, A. P., Özen, Z., Kartal, E., Emre, İ. E., Selçukcan Erol, Ç., Koçoğlu, F. Ö., Güngör, G., Güneyli, H. C., Başaranoğlu, G., Ünlüsoy, E. Ö., Uğur, H. Ö., Buluç Bulğen, S., Çolakoğlu, N., Sayılgan, C., Pekel, A. F., Pişmişoğlu, H., Salihoğlu, Z., Yüceyar, L., Karaca, S., … Bakan, N. (2018). Analysis of the incidence and predictive factors of chronic postoperative pain in adult population. The Journal of Tepecik Education and Research, 28(2), 89-94. https://doi.org/10.5222/terh.2018.089
- Individual participant dataSharing planned: Yes. Patient questioner
Related trials for Chronic Postoperative Pain
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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.
Pervin Bozkurt Sutaş, Prof. Dr study director
Istanbul University Cerrahpaşa Medical Faculty
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Postoperative Pain, run by Istanbul University at 6 sites in Turkey (Türkiye).
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 1 inclusion and 1 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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?
Incidence of postoperative chronic pain (time frame: postoperative 3 months). 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 NCT02190682, which also lists 1 linked publication.
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 27 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.