Dataset Information

Evaluation of the efficacy and safety of conventional and interlaminar full-endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-F trial): Protocol for a prospective, randomized, multicenter trial.

ABSTRACT: Lumbar spinal stenosis is a common spinal degenerative condition. Minimally invasive interlaminar full-endoscopic decompressive laminectomy provides greater patient satisfaction and faster recovery than open decompressive laminectomy. The aim of our randomized controlled trial will be to compare the safety and efficacy of interlaminar full-endoscopic laminectomy and open decompressive laminectomy. Our trial will include 120 participants (60 per group) who will undergo surgical treatment for lumbar spinal stenosis. The primary outcome will be the Oswestry Disability Index measured at 12 months postoperatively. Secondary patient-reported outcomes will include back and radicular leg pain measured via a visual analog scale; the Oswestry Disability Index; the Euro-QOL-5 Dimensions score measured at 2 weeks and at 3, 6, and 12 months postoperatively; and patient satisfaction. The functional measures will include time to return to daily activities postoperatively and walking distance/time. The surgical outcomes will include postoperative drainage, operation time, duration of hospital stay, postoperative creatine kinase (an indicator of muscle injury) level, and postoperative surgical scarring. Magnetic resonance and computed tomography images and simple radiographs will be obtained for all patients. The safety outcomes will include surgery-related complications and adverse effects. All evaluations will be performed by a single assessor at each participating hospital who will be blinded to group allocation. The evaluations will be conducted preoperatively and at 2 weeks and 3, 6, and 12 months postoperatively. The randomized, multicenter design of the trial, blinding, and justification of the sample size will reduce the risk of bias in our trial. The results of the trial will provide data regarding the use of interlaminar full-endoscopic laminectomy as an alternative to open decompressive laminectomy that results in similar surgical findings with less invasiveness. Trial registration: This trial is registered at cris.nih.go.kr. (KCT0006198; protocol version 1; 27 May 2021).

SUBMITTER: Kim JS

PROVIDER: S-EPMC10075401 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Evaluation of the efficacy and safety of conventional and interlaminar full-endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-F trial): Protocol for a prospective, randomized, multicenter trial.

Kim Jin-Sung JS Bae Junseok J Lee Dong Chan DC Shin Sang-Ha SH Keum Han Joong HJ Choi Young Soo YS Eun Sang Soo SS Shin Seung Ho SH Hong Hyun Jin HJ Kim Ji Yeon JY Kim Tae Hyun TH Lim Woojung W Kim Junghoon J Park Sang-Min SM Park Hyun-Jin HJ Lee Hong-Jae HJ

PloS one 20230405 4

Lumbar spinal stenosis is a common spinal degenerative condition. Minimally invasive interlaminar full-endoscopic decompressive laminectomy provides greater patient satisfaction and faster recovery than open decompressive laminectomy. The aim of our randomized controlled trial will be to compare the safety and efficacy of interlaminar full-endoscopic laminectomy and open decompressive laminectomy. Our trial will include 120 participants (60 per group) who will undergo surgical treatment for lumb ...[more]

PMID: 37018239

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Project description:Background:The indications of different endoscopic and endoscopically assisted translaminar approaches for lumbar spinal stenosis are not well-defined, and validated protocols for the use of the transforaminal over the interlaminar approach are lacking. Methods:We performed a retrospective study employing an image-based patient stratification protocol of stenosis location (type I-central canal, type II-lateral recess, type III-foraminal, type IV-extraforaminal) and clinical outcomes on 249 patients consisting of 137 (55%) men and 112 (45%) women with an average age of 56.03±16.8 years who underwent endoscopic surgery for symptomatic spinal stenosis from January 2013 to February 2019. The average follow-up of 38.27±27.9 months. The primary clinical outcome measures were the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and modified Macnab criteria. Results:The frequency of stenosis configuration in decreasing order was as follows: type I-121/249; 48.6%, type III-104/249; 41.8%, type II-15/249; 6%, and type IV-9/249; 3.6%. The transforaminal approach (137/249; 55.0%) was used in most type II to IV lesions followed by the interlaminar approach (78/249; 31.3%), and the full endoscopic approach (12/249; 4.8%), and the endoscopically assisted translaminar approach (8/249; 3.2%) which was exclusively used for type I lesions. Macnab outcomes analysis showed Excellent in 47 patients (18.9%), Good in 178 (71.5%), Fair in 18 (7.2%) and Poor in 6 (2.4%), respectively. Paired two-tailed t-test showed statistically significant VAS (5.46±2.1; P<0.0001) and ODI (37.1±16.9; P<0.0001) reductions as a result of the endoscopic decompression surgery. Cross-tabulation of the Macnab outcomes versus the endoscopic approach and surgical technique confirmed beneficial association of the approach selection with Excellent (P=0.001) and Good (P<0.0001) outcomes with statistically significance. Conclusions:This study suggests that in the hands of skilled endoscopic spines surgeon use of an image-based stenosis location protocol may contribute to obtaining Excellent and Good clinical outcomes in a high percentage (93%) of patients suffering from lumbar stenosis related radiculopathy. Additional comparative studies should examine the prognostic value of choosing the endoscopic approach on the basis of the proposed four-type stenosis protocol by correlating its impact on outcomes with preoperative diagnostic injections and intraoperative direct visualization of symptomatic pain generators under local anesthesia and sedation.

Project description:ObjectiveTo introduce a technique of laminotomy using a common trephine to enlarge the interlaminar space at L4/5 segment for interlaminar endoscopic lumbar discectomy (IELD) and report the anatomical basis of this procedure, technical details, as well as primary clinical outcomes of a consecutive patient cohort with L4/5 lumbar disc herniation (LDH).MethodsOn anteroposterior fluoroscopy, the intersection of the medial edge of the inferior articular process and the inferior endplate of L4 vertebra was taken as the target. Using a common trephine, laminotomy was performed to remove a big portion of the posterior wall of the canal under the guidance of endoscopy. From June 2018 to December 2021, the consecutive patients who underwent L4/5 IELD were prospectively studied. Clinical outcomes were assessed at the day before surgery, 1 day, 1 month, 3 months, 12 months after surgery, and the last follow-up. Numerical Rating Scale, Roland-Morris Disability Questionnaire (RMDQ), and MacNab criteria were used to evaluate back and leg pain, the quality of life, and clinical efficacy, respectively.ResultsThere were 64 men and 44 women, with an age of 50.3 ± 14.9 years. The operating time was 74.54 ± 17.42 minutes. The mean follow-up time was 32.7 ± 18.6 months (range, 12-64 months). The complications of IELD included numbness, neck pain, and recurrence. Both leg pain (6.2 ± 1.9 vs. 1.8 ± 0.8, p < 0.001) and back pain (3.1 ± 2.3 vs. 1.7 ± 0.9, p < 0.001) quickly improved after this procedure and maintained (1.1 ± 1.5, 1.1 ± 1.3) at final follow-up. Physical disability due to back pain, as assessed using RMDQ, was improved remarkably after surgery (15.0 ± 5.8 vs. 2.9 ± 4.1, p < 0.001). In addition, MacNab outcome grade was evaluated as good-to-excellent in 96 cases (88.9%).ConclusionA convenient technique of laminotomy using a common trephine was proposed for the L4/5 IELD. It can efficiently enlarge the interlaminar entry to perform endoscopic discectomy. This procedure is particularly suitable for treating LDH with concomitant lumbar spinal stenosis and migrated herniated disc.

Dataset Information

Evaluation of the efficacy and safety of conventional and interlaminar full-endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-F trial): Protocol for a prospective, randomized, multicenter trial.

Publications

Evaluation of the efficacy and safety of conventional and interlaminar full-endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-F trial): Protocol for a prospective, randomized, multicenter trial.

Similar Datasets

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