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Randomized clinical trial of acetazolamide administration and/or prone positioning in mitigating wound complications
Shima Shahjouei1, Sara Hanaei1, Zohreh Habibi1
1Department of Neurosurgery, Children's Hospital Medical Center, and.
Insights
Postoperative prone positioning may reduce complications like CSF leakage and collection in pediatric tethered cord syndrome (TCS) patients after spinal untethering surgery. Acetazolamide did not show significant benefits and had side effects.
Area of Science:
- Neurosurgery
- Pediatric Surgery
- Clinical Trials
Background:
- No established evidence-based guidelines exist for managing pediatric patients post-spinal cord untethering surgery for tethered cord syndrome (TCS).
- Postoperative complications can significantly impact patient outcomes and recovery following these procedures.
Purpose of the Study:
- To evaluate the effectiveness of prone positioning and acetazolamide administration in reducing complication rates after spinal cord untethering surgery in pediatric TCS patients.
- To compare outcomes between four groups: acetazolamide, prone positioning, combined therapy, and no intervention.
Main Methods:
- A randomized clinical trial involving 161 pediatric patients diagnosed with TCS.
- Patients were randomly assigned to receive postoperative acetazolamide, prone positioning, both, or no intervention for 10 days.
- Key failure outcomes included cerebrospinal fluid (CSF) leakage, CSF collection, wound dehiscence, surgical site infection, and secondary wound repair.
Main Results:
- The overall complication rate was 12.42%. Specific complications included CSF leakage (5.6%), CSF collection (7.5%), wound dehiscence (1.2%), and infection (1.9%).
- Prone positioning significantly reduced rates of CSF leakage (p=0.042) and CSF collection (p=0.036).
- Acetazolamide, alone or combined with prone positioning, did not significantly lower complication rates and was associated with side effects.
Conclusions:
- Prone positioning appears to be a beneficial intervention for reducing postoperative complications, specifically CSF leakage and collection, in pediatric patients undergoing spinal cord untethering for TCS.
- Acetazolamide administration is not recommended for routine postoperative management in this patient population due to lack of efficacy and potential side effects.
- Clinical trial registration: NCT01867268.
Abstract:
OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS The current study demonstrates the possible role of prone positioning in mitigating the complication rates subsequent to untethering surgeries. Clinical trial registration no.: NCT01867268 ( clinicaltrials.gov ).
