NCT02190682

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
733

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

July 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.5 years

First QC Date

July 12, 2014

Last Update Submit

January 23, 2020

Conditions

Keywords

postoperativechronicpainsoftware

Outcome Measures

Primary Outcomes (1)

  • 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.

    postoperative 3 months

Secondary Outcomes (1)

  • preparation of software for the prediction of postoperative chronic pain

    8 months

Eligibility Criteria

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

all cases undergoing surgery

You may qualify if:

  • all cases operated in one month period

You may not qualify if:

  • cases who cannot be followed for 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34303, Turkey (Türkiye)

Location

Bezm-i Alem University

Istanbul, Turkey (Türkiye)

Location

Istanbul Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University Cardiology Institute

Istanbul, Turkey (Türkiye)

Location

Istanbul University Informatics Department

Istanbul, Turkey (Türkiye)

Location

Tepecik Research and Training Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeBronchiolitis Obliterans SyndromePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Pervin Bozkurt Sutaş, Prof. Dr

    Istanbul University Cerrahpaşa Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr

Study Record Dates

First Submitted

July 12, 2014

First Posted

July 15, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 30, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Patient questioner

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Jan 2020- Jan 2022
Access Criteria
when it is published by a journal

Locations