Neurosurgery · 2025
Dural Tenting in Elective Craniotomies: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Przepiorka Lukasz, Wójtowicz Katarzyna, Kujawski Sławomir, Wiśniewski Karol, Bobeff Ernest Jan, Kruk Rafał, Kulesza Bartłomiej, Fortuniak Jan, Mróz Adam, Dunaj Piotr, Kaspera Maciej, Hoppe Szymon, Krystkiewicz Kamil, Kwiecień Katarzyna, Szczepanek Dariusz, Jaskólski Dariusz J, Ładziński Piotr, Rola Radosław, Furtak Jacek, Trojanowski Tomasz, Marchel Andrzej, Kunert Przemysław
Аннотация
BACKGROUND AND OBJECTIVES: Dural tenting sutures are a well-known neurosurgical technique. However, claims of them preventing extradural hematomas (EDHs) lack evidence-based support. For that reason, we decided to evaluate the noninferiority of routinely not tenting the dura in elective supratentorial craniotomies.
METHODS: A randomized, multicenter, investigator-blinded and participant-blinded, controlled interventional trial with 1:1 allocation. We included adults undergoing elective, supratentorial craniotomies. Not tenting the dura was an intervention, and the control group consisted of patients with at least 3 dural tenting sutures. The primary outcome was the risk of reoperation because of EDH, and secondary outcomes included a selection of clinically relevant outcomes.
RESULTS: We randomized 490 patients into intervention (238, 49%, not tenting the dura) and control (252, 51%, dural tenting) study groups, as per intention-to-treat analysis. Proportions of EDH surgeries in the intervention group were noninferior in comparison with the control group and not significantly different using the intention-to-treat (0.8% and 0.4%, P = .98), per-protocol (0.5%, 0.4%, P > .99), and as-treated (0.5%, 0.7%, P > .99) analyses. There were no significant differences in secondary outcomes: postoperative 30-day mortality (0.8%, 1.2%, P > .99), postoperative 30-day readmission (1.7%, 4.4%, P = .99), new neurological deficit or deterioration of a previous (19.7%, 15.5%, P = .81), cerebrospinal fluid leak (1.3%, 4.4%, P > .99), deterioration of postoperative headache over 5 numerical rating scale (4.4%, 2.4%, P = .85), epidural collection thickness over 3 mm (90.8%, 87.3%, P = .81), and midline shift over 5 mm (7.6%, 4.8%, P = .791) in the intervention and control study groups in intention-to-treat analysis. Similarly, secondary outcomes were not different in per-protocol and as-treated analyses. Other than cerebrospinal fluid leaks and EDHs, there were 17 adverse events in the intervention group and 19 in the control group (intention-to-treat analysis, 7.1% and 7.5%, respectively).
CONCLUSION: This trial demonstrates the noninferiority of omitting prophylactic dural tenting for postoperative EDH requiring surgery in elective, supratentorial craniotomies.
METHODS: A randomized, multicenter, investigator-blinded and participant-blinded, controlled interventional trial with 1:1 allocation. We included adults undergoing elective, supratentorial craniotomies. Not tenting the dura was an intervention, and the control group consisted of patients with at least 3 dural tenting sutures. The primary outcome was the risk of reoperation because of EDH, and secondary outcomes included a selection of clinically relevant outcomes.
RESULTS: We randomized 490 patients into intervention (238, 49%, not tenting the dura) and control (252, 51%, dural tenting) study groups, as per intention-to-treat analysis. Proportions of EDH surgeries in the intervention group were noninferior in comparison with the control group and not significantly different using the intention-to-treat (0.8% and 0.4%, P = .98), per-protocol (0.5%, 0.4%, P > .99), and as-treated (0.5%, 0.7%, P > .99) analyses. There were no significant differences in secondary outcomes: postoperative 30-day mortality (0.8%, 1.2%, P > .99), postoperative 30-day readmission (1.7%, 4.4%, P = .99), new neurological deficit or deterioration of a previous (19.7%, 15.5%, P = .81), cerebrospinal fluid leak (1.3%, 4.4%, P > .99), deterioration of postoperative headache over 5 numerical rating scale (4.4%, 2.4%, P = .85), epidural collection thickness over 3 mm (90.8%, 87.3%, P = .81), and midline shift over 5 mm (7.6%, 4.8%, P = .791) in the intervention and control study groups in intention-to-treat analysis. Similarly, secondary outcomes were not different in per-protocol and as-treated analyses. Other than cerebrospinal fluid leaks and EDHs, there were 17 adverse events in the intervention group and 19 in the control group (intention-to-treat analysis, 7.1% and 7.5%, respectively).
CONCLUSION: This trial demonstrates the noninferiority of omitting prophylactic dural tenting for postoperative EDH requiring surgery in elective, supratentorial craniotomies.