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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

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...

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Autores principales: Kim, Jin-Sung, Bae, Junseok, Lee, Dong Chan, Shin, Sang-Ha, Keum, Han Joong, Choi, Young Soo, Eun, Sang Soo, Shin, Seung Ho, Hong, Hyun Jin, Kim, Ji Yeon, Kim, Tae Hyun, Lim, Woojung, Kim, Junghoon, Park, Sang-Min, Park, Hyun-Jin, Lee, Hong-Jae
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10075401/
https://www.ncbi.nlm.nih.gov/pubmed/37018239
http://dx.doi.org/10.1371/journal.pone.0283924
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author Kim, Jin-Sung
Bae, Junseok
Lee, Dong Chan
Shin, Sang-Ha
Keum, Han Joong
Choi, Young Soo
Eun, Sang Soo
Shin, Seung Ho
Hong, Hyun Jin
Kim, Ji Yeon
Kim, Tae Hyun
Lim, Woojung
Kim, Junghoon
Park, Sang-Min
Park, Hyun-Jin
Lee, Hong-Jae
author_facet Kim, Jin-Sung
Bae, Junseok
Lee, Dong Chan
Shin, Sang-Ha
Keum, Han Joong
Choi, Young Soo
Eun, Sang Soo
Shin, Seung Ho
Hong, Hyun Jin
Kim, Ji Yeon
Kim, Tae Hyun
Lim, Woojung
Kim, Junghoon
Park, Sang-Min
Park, Hyun-Jin
Lee, Hong-Jae
author_sort Kim, Jin-Sung
collection PubMed
description 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).
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spelling pubmed-100754012023-04-06 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 Bae, Junseok Lee, Dong Chan Shin, Sang-Ha Keum, Han Joong Choi, Young Soo Eun, Sang Soo Shin, Seung Ho Hong, Hyun Jin Kim, Ji Yeon Kim, Tae Hyun Lim, Woojung Kim, Junghoon Park, Sang-Min Park, Hyun-Jin Lee, Hong-Jae PLoS One Study Protocol 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). Public Library of Science 2023-04-05 /pmc/articles/PMC10075401/ /pubmed/37018239 http://dx.doi.org/10.1371/journal.pone.0283924 Text en © 2023 Kim et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Study Protocol
Kim, Jin-Sung
Bae, Junseok
Lee, Dong Chan
Shin, Sang-Ha
Keum, Han Joong
Choi, Young Soo
Eun, Sang Soo
Shin, Seung Ho
Hong, Hyun Jin
Kim, Ji Yeon
Kim, Tae Hyun
Lim, Woojung
Kim, Junghoon
Park, Sang-Min
Park, Hyun-Jin
Lee, Hong-Jae
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10075401/
https://www.ncbi.nlm.nih.gov/pubmed/37018239
http://dx.doi.org/10.1371/journal.pone.0283924
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