Ex vivo and in vivo evaluation of transsphenoidal Liqoseal application to prevent cerebrospinal fluid leakage.

BACKGROUND: Despite improvements in closure techniques by using a vital nasoseptal flap, the use of sealing materials, and improved neurosurgical techniques, cerebrospinal fluid (CSF) leak after transsphenoidal surgery still is a clinically relevant problem. Liqoseal® (Polyganics bv, Groningen, The Netherlands) is a CE-approved bioresorbable sealant patch for use as an adjunct to standard methods of cranial dural closure to prevent CSF leakage. This study aims to evaluate the application of Liqoseal in transsphenoidal surgery ex vivo and in vivo. METHODS: 1. We created an ex vivo setup simulating the sphenoidal anatomy, using a fluid pump and porcine dura positioned on a conus with the anatomical dimensions of the sella to evaluate whether the burst pressure of Liqoseal applied to a bulging surface was above physiological intracranial pressure. Burst pressure was measured with a probe connected to dedicated computer software. Because of the challenging transsphenoidal environment, we tested in 4 groups with varying compression weight and time for the application of Liqoseal. 2. We subsequently describe the application of Liqoseal® in 3 patients during transsphenoidal procedures with intraoperative CSF leakage to prevent postoperative CSF leakage. RESULTS: 1. Ex vivo: The overall mean burst pressure in the transsphenoidal setup was 231 (± 103) mmHg. There was no significant difference in mean burst pressure between groups based on application weight and time (p = 0.227). 2. In Vivo: None of the patients had a postoperative CSF leak. No nose passage problems were observed. One patient had a postoperative meningitis and ventriculitis, most likely related to preoperative extensive CSF leakage. Postoperative imaging did not show any local infection, swelling, or other device-related adverse effects. CONCLUSIONS: We assess the use of Liqoseal® to seal a dural defect during an endoscopic transsphenoidal procedure as to be likely safe and potentially effective.

Five-Year Outcome of Laparoscopic Fundoplication in Pediatric GERD Patients: a Multicenter, Prospective Cohort Study.

BACKGROUND: Gastroesophageal reflux disease (GERD) is a common disease in children. When drug treatment fails, laparoscopic anti-reflux surgery (LARS) is considered. Short-term follow-up studies report high success rates; however, few studies report long-term results. The aim of this study was to describe the long-term effects of LARS in pediatric patients. METHODS: A prospective, multicenter study of 25 laparoscopic fundoplication patients was performed. At 3 months and 1, 2, and 5 years postoperatively, patients and caregivers were asked to complete the gastroesophageal reflux symptom questionnaire to assess symptoms and the PedsQL™ to assess health-related quality of life (HRQoL). RESULTS: Reflux symptom severity was still significantly improved 5 years after LARS compared with preoperative levels (p < 0.0001). However, 26% of patients reported moderate or severe reflux symptoms. Dysphagia was reported in 13% of patients 5 years after LARS and was more common in children with neurologic impairment and children who underwent a Nissen procedure. The increase in HRQoL 3 months postoperatively appears to decline over time: 5 years after surgery, HRQoL was lower, though not significantly, than 3 months postoperatively. HRQoL at 5 years was still higher, though also not significantly, than preoperative levels. The presence of reflux symptoms after surgery was not significantly associated with lower HRQoL. CONCLUSIONS: LARS is effective for therapy-resistant GERD in children. Five years after surgery, reflux symptoms are still improved. However, we observed a decline in symptom-free patients over time. The initial increase in HRQoL shortly after LARS appears to decline over time. TRIAL REGISTRATION: Dutch national trial registry Identifier: 2934 ( www.trialregister.nl ).