Epiduroscopic Laser Discectomy Procedures

NCT ID: NCT03319875

Last Updated: 2017-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 163 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2017-06-25

Brief 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

Disc, Herniated

Keywords

Epiduroscopy; Discectomy; Holmium Yag laser; Lumbar disc herniation; Minimally invasive treatment

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Epiduroscopic Laser Discectomy

Caudal epidural space after passing through sacral hiatus

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with low back and / or leg pain for at least 3 months or more

2. Patients who do not benefit from conservative treatment

3. In patients who underwent Lumbar MRI examinations and had axial sheaths with a herniation of 3 mm or more

Exclusion Criteria

1. Patients with bleeding diathesis in preoperative laboratory tests

2. Patients with any local or systemic infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Serbülent Gökhan BEYAZ

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Sakarya University Algology

Identifier Type: -

Identifier Source: org_study_id