G97.80
Conditions
Interventions
Group 1: Dural Closure augmented with L-PRF alone
Group 2: Conventional dural closure with synthetic materials and without augmentation using L-PRF
Sponsors
Klinik für Neurochirurgie, Universitätsklinikum Frankfurt am Main
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Elective resection of sellar tumors (pituitary adenomas), elective craniotomy and resction of supratentorial lesions, elective craniotomy and resection of infratentorial lesions, age > 18 years
Exclusion criteria
Exclusion criteria: Age <18 years, preoperative signs of boney destruction of the skull or skull base, patients undergoing repeat surgical intervention, obvious intraoperative CSF fistula among patients undergoing transsphenoidal surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the number of occurences of postoperative rhinoliquorrhea/CSF fistulas. This will be compared between patients underoing dural closure with L-PRF with and without synthetic materials and syntheic materials alone within 3 months following initial surgical intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include: the time of occurence of possible CSF fistulas, the number and form of L-PRF products used intraoperatively, MRI characteristics of pre and postoperative tumor volume, Knosp-Grades (among pituitary adenomas) and contrast agent enrichment, occurence of infections and length of surgery. | — |
Countries
Germany
Outcome results
None listed