Evidence map›Paper›PMID 37018239›Full record

ArticlePloS one2023

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.

Jin-Sung Kim, Junseok Bae, Dong Chan Lee, Sang-Ha Shin, Han Joong Keum, Young Soo Choi, Sang Soo Eun, Seung Ho Shin, Hyun Jin Hong, Ji Yeon Kim and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 3 countries.

Jin-Sung KimDepartment of Neurosurgery, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0001-5086-0875
Junseok BaeDepartment of Neurosurgery, Chungdam Wooridul Spine Hospital, Seoul, Korea.
Dong Chan LeeDepartment of Neurosurgery, Wiltse Memorial Hospital, Anyang, Korea.
Sang-Ha ShinDepartment of Neurosurgery, Chungdam Wooridul Spine Hospital, Seoul, Korea.
Han Joong KeumDepartment of Neurosurgery, Chungdam Wooridul Spine Hospital, Seoul, Korea.
Young Soo ChoiDepartment of Neurosurgery, Chungdam Wooridul Spine Hospital, Seoul, Korea.
Sang Soo EunDepartment of Orthopaedic Surgery, Chungdam Wooridul Spine Hospital, Seoul, Korea.
Seung Ho ShinDepartment of Neurosurgery, Wiltse Memorial Hospital, Anyang, Korea.
Hyun Jin HongDepartment of Neurosurgery, Wiltse Memorial Hospital, Anyang, Korea.
Ji Yeon KimDepartment of Neurosurgery, Wiltse Memorial Hospital, Anyang, Korea.
Tae Hyun KimDepartment of Neurosurgery, Wiltse Memorial Hospital, Anyang, Korea.
Woojung LimDepartment of Neurosurgery, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Junghoon KimDepartment of Neurosurgery, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Sang-Min ParkSpine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, Korea.
Hyun-Jin ParkDepartment of Orthopedic Surgery, Spine Center, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
Hong-Jae LeeDepartment of Neurosurgery, Daejeon St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0001-6775-4673
Leon Wiltse Memorial Hospital · KRWooridul Hospital · KRHallym University Kangnam Sacred Heart Hospital · KRSeoul National University Bundang Hospital · KRSt. Mary's Hospital · USThe Catholic University of Korea Seoul St. Mary's Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

LaminectomySpinal StenosisDecompression, SurgicalHumansLumbar VertebraeMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment Outcome

Identifiers

PMID37018239
PMCPMC10075401
OpenAlexW4362602469

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.