Decompression with or without Duraplasty for Chiari I and Syringomyelia.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Limbrick David D, Shannon Chevis N, Bayman Emine O, Meehan Thanda, Kallem Marisa, Ackerman Laurie L, Adelson P David, Ahmed Raheel, Albert Gregory, Aldana Philipp R, Alden Tord D, Anderson Richard C E, Baird Lissa C, Bauer David, Bethel-Anderson Tammy, Bierbrauer Karin, Brockmeyer Douglas L, Chern Joshua J, Couture Daniel E, Daniels David J, Dauser Robert C, Dlouhy Brian J, Durham Susan R, Ellenbogen Richard G, Eskandari Ramin, Gannon Stephen R, Grant Gerald A, Graupman Patrick C, Greenberg Jacob K, Greene Stephanie, Greenfield Jeffrey P, Gross Naina L, Guillaume Daniel J, Hankinson Todd C, Heuer Gregory, Iantosca Mark, Iskandar Bermans J, Jackson Eric M, Jallo George I, Johnston James M, Keating Robert F, Kelly Michael P, Kennedy Elaine, Krieger Mark D, Kulkarni Abhaya V, Labuda Rick, Leonard Jeffrey R, Maher Cormac O, Mangano Francesco T, McComb J Gordon, McEvoy Sean D, McKinstry Robert C, Menezes Arnold H, Niazi Toba N, Oakes Jerry, Olavarria Greg, O'Neill Brent R, Poppe Dorothy, Ragheb John, Reeves Samuel, Reynolds Lisa, Selden Nathan R, Shah Manish N, Shimony Joshua S, Smyth Matthew D, Spears Sandy, Stone Scellig S D, Strahle Jennifer M, Tamber Mandeep, Tramelli Gina, Tuite Gerald F, Tyler-Kabara Elizabeth C, Vance Haley, Wait Scott D, Wellons John C, Whitehead William E, Yahanda Alexander T, Yan Yan, Dacey Ralph G, Park Tae Sung, Torner James C, Park-Reeves Syringomyelia Research Consortium Investigators
Аннотация
METHODS: We conducted a multicenter, cluster-randomized, controlled trial of PFD with duraplasty (PFD-D) as compared with PFD alone. Persons 21 years of age or younger with cerebellar tonsillar ectopia of at least 5 mm and a maximum syrinx diameter of 3.0 to 9.9 mm were enrolled at 38 centers. Centers were cluster-randomized: all the participants within each center underwent the same intervention. The primary outcome was surgical complications within 6 months. Secondary outcomes were clinical improvement, syrinx reduction, and repeat decompression at 10 to 24 months and the change in overall health-related quality of life at 6 to 24 months.
RESULTS: A total of 162 participants were included in the trial, of whom 78 were assigned to undergo PFD-D and 84 to undergo PFD alone. The percentage of participants with complications within 6 months was 14% with PFD-D and 6% with PFD (adjusted odds ratio, 2.59; 95% confidence interval [CI], 0.86 to 7.84; P = 0.11). At 24 months, the percentage of participants with clinical improvement was 58% with PFD-D and 46% with PFD; the mean (±SD) syrinx reduction was 3.08±2.33 mm and 1.22±1.79 mm, respectively; and the percentage of participants with repeat decompression was 3% and 14%. Changes in health-related quality of life were similar in the two groups.
CONCLUSIONS: The percentage of participants with surgical complications did not differ significantly between those who underwent PFD-D and and those who underwent PFD alone. Larger trials are needed to determine the relative benefits and risks of these two procedures. (Funded by the Patient-Centered Outcomes Research Institute and others; ClinicalTrials.gov number, NCT02669836.).