Randomized clinical trial of acetazolamide administration and/or prone positioning in mitigating wound complications following untethering surgeries

Abstract

<jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>No evidence-based guideline has been approved for the postoperative management of pediatric patients with tethered cord syndrome (TCS). The purpose of this randomized clinical trial was to evaluate the effectiveness of prone positioning and acetazolamide administration on complication rates following spinal cord untethering surgeries.</jats:p></jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>From October 2012 to February 2015, patients with a primary diagnosis of TCS who were admitted to the Children's Medical Center Hospital of Iran were randomly allocated to 1 of 4 intervention modality groups postoperatively: 1) Group A, acetazolamide administration for 10 days; 2) Group B, prone positioning for 10 days; 3) Group C, acetazolamide administration and prone positioning for 10 days; and 4) Group D, no intervention. CSF leakage, CSF collection, wound dehiscence, operative site infection, and secondary surgical wound repair were considered failure.</jats:p></jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>A total of 161 patients were enrolled in this study (Group A, n = 39 [24.2%]; Group B, n = 41 [25.5%]; Group C, n = 39 [24.2%]; and Group D, n = 42 [26.1%]). The overall failure rate was 12.42% (20 patients). Complication rates through pooled analyses were as follows: CSF leakage (n = 9, 5.6%), CSF collection (n = 12, 7.5%), wound dehiscence (n = 2, 1.2%), and infection of operation site (n = 3, 1.9%). Two patients (1.2%) required surgical secondary wound repair due to complications. CSF leakage and collection rates were significantly lower in patients who underwent prone positioning (p = 0.042 and 0.036, respectively). The administration of acetazolamide, either isolated or in combination with prone positioning, not only could not significantly lower the complication rates, but also added the burden of side effects.</jats:p></jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>The current study demonstrates the possible role of prone positioning in mitigating the complication rates subsequent to untethering surgeries.</jats:p> <jats:p>Clinical trial registration no.: NCT01867268 (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="clinicaltrials.gov" ext-link-type="uri" xlink:type="simple">clinicaltrials.gov</jats:ext-link>)</jats:p></jats:sec>

Towards Guideline-Based Management of Tethered Cord Syndrome in Spina Bifida: A Global Health Paradigm Shift in the Era of Prenatal Surgery

“…[39][40][41] Among surgical studies (n = 12), there was no clear or standardized description in the untethering technique utilized. [30][31][32][33][34]37,38,[42][43][44] Among these surgical studies, only 6 described their complications in the results section of the respective article. Additionally, 5 out of the 13 studies did not provide information on the length of follow-up after surgical intervention.…”

“…Shang et al 36 had at least 38 individuals (11.6%) with no neurological deficit. The presence of neurologic symptoms was not a prerequisite for untethering in the study by Shahjouei et al 37 Lastly, only 3 studies used urodynamic testing as part of their patients' examination. 31,35,38…”

“…There were 12 studies that focused on surgical management, of which only 4 described their complications. 32,37,38,44 Overall, the mortality rate after spinal cord untethering was relatively low and usually resulted from infectious complications such as meningitis. 52 Given the morbidities (e.g., infectious complications, pseudomeningocele) affecting 10%-35% of cases, [53][54][55][56][57] it should be noted that individuals with MMC are at an even higher risk than those with occult spinal dysraphism due to increased incidence of multiple recurrences, scarring, and poorly vascularized covering tissues.…”

Development of best practices to minimize wound complications after complex tethered spinal cord surgery: a modified Delphi study

“…1,9,26,31 Reported complication rates can vary depending on the underlying pathology, for example, from 3.2% (infection) and 5.9% (CSF leak) in simple filum release 9 to 5.6% and 16.7% in detethering following myelomeningocele repair 20 with overall rates between 1% and 17% for each complication in all pathologies. 26,29,31 The literature on this subject is limited to mostly retrospective studies, with a handful of studies on specific strategies to mitigate postoperative CSF leaks. 23,24,29 Because of the wide variation that exists across centers and surgeons with regard to the techniques used to minimize wound infections and CSF leaks following complex tethered cord release, we first conducted a systematic literature review of existing evidence for a series of pre-, intra-, and postoperative preventative strategies.…”

“…26,29,31 The literature on this subject is limited to mostly retrospective studies, with a handful of studies on specific strategies to mitigate postoperative CSF leaks. 23,24,29 Because of the wide variation that exists across centers and surgeons with regard to the techniques used to minimize wound infections and CSF leaks following complex tethered cord release, we first conducted a systematic literature review of existing evidence for a series of pre-, intra-, and postoperative preventative strategies. Given the lack of sufficient empirical evidence available, we used the Delphi method of building consensus among a group of experienced pediatric neurosurgeons to frame best practice statements.…”