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CompletedNCT03319875

Epiduroscopic Laser Discectomy Procedures

Evaluation of The Efficacy of Epiduroscopic Discectomy Procedures: A Retroscopic Study

Status
Completed
Phase
Study type
Observational
Enrollment
163 (actual)
Sponsor
Sakarya University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Epiduroscopy or spinal endoscopy is the imaging of the epidural space using a percutaneous and minimally invasive fiberoptic imaging device. The definitive diagnosis and treatment of chronic pain is increasingly prevalent with epiduroscopy. Recently, as a result of these studies it has been reported that laser therapy with epiduroscopy applied discectomy during multiple lesions. Investigators aimed to retrospectively investigate the efficacy of epiduroscopic discectomy procedures performed at the Algology Clinic.

Detailed description

In this study, epiduroscopic discectomy procedures performed between January 2012 and July 2016 at the Algology Clinic of the Department of Anesthesiology and Reanimation, Sakarya University Training and Research Hospital, were examined retrospectively. After approval was received from the Sakarya University Faculty of Medicine's Ethics Committee, patient information was obtained from the KarMed (Kardelen Software, Turkey) hospital information system. Files were scanned from the hospital archive. The age, gender, weight, lumbar disc herniation level, preoperative and postoperative surgical history, amount of physiological saline used during the procedure and duration of the procedure, whether a lumbar epidural steroid (LES) was used during the procedure, the amount of epiduroscopic laser use during the procedure, and complications after the procedure were examined. The Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) scores were recorded preoperatively, as well as after 2 weeks and 2, 6, and 12 months postoperatively from the patient files. The 2007 Number Cruncher Statistical System (NCSS, Kaysville, Utah, USA) program was used for statistical analysis. The Student t-test and Mann-Whitney U test were used for descriptive statistical methods (mean, standard deviation, median, frequency, ratio, minimum, maximum) in two groups, as well as the normal distribution of quantitative data. The Kruskal-Wallis test and Mann-Whitney U test were used in the comparison of three groups with no normal distribution. The Pearson Chi-square test was used to evaluate qualitative data, and Spearman's correlation analysis was used to evaluate intervariable relationships. The Friedman and Wilcoxon signed ranks tests were used in the evaluation of three or more follow-up parameters without normal distribution. Diagnostic screening tests (sensitivity, specificity) and receiver operating characteristic (ROC) analysis were used to determine the cutoff value for age. Significance was evaluated at the level of p \< (0.01).

Conditions

Interventions

TypeNameDescription
DEVICEEpiduroscopic Laser DiscectomyCaudal epidural space after passing through sacral hiatus

Timeline

Start date
2012-01-01
Primary completion
2016-06-30
Completion
2017-06-25
First posted
2017-10-24
Last updated
2017-10-24

Source: ClinicalTrials.gov record NCT03319875. Inclusion in this directory is not an endorsement.

Epiduroscopic Laser Discectomy Procedures (NCT03319875) · Clinical Trials Directory