Dural Tenting Sutures in Neurosurgery - is it Necessary?
NCT ID: NCT03658941
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
490 participants
INTERVENTIONAL
2018-09-07
2022-09-01
Brief Summary
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In this study, half of the randomly assigned participants will undergo craniotomy without dural tenting sutures and will be considered an intervention group. The other half will undergo craniotomy with these sutures.
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Detailed Description
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Yet, there have been several retrospective reports questioning the ongoing need for dural tenting sutures. Dandy's explanation that the hemostasis under hypotensive conditions is deceiving and eventually causes EDH may be obsolete. These days, proper intra- and postoperative care, including maintenance of normovolemia and normotension and the use of modern hemostatic agents, may be enough for effective hemostasis. Evading of this suturing technique by some surgeons supports this argument even further.
Thus, there is a fundamental need to evaluate the necessity of dural tenting sutures in an unbiased, evidence-based manner.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Both groups will be followed radiologically and clinically, in the exact same manner.
PREVENTION
TRIPLE
* Access to the randomization code will be strictly controlled.
* The surgeon will receive information on subject's allocation after commencing the surgery.
The study blind will be broken:
1. During interim monitoring, after recruiting the first 100 patients.
2. On completion of the clinical study and after the study database has been locked.
3. When patients' safety requires access to allocation data.
Study Groups
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No dural tenting sutures
No dural tenting techniques
No dural tenting techniques
Not applying dural tenting sutures during closure of a craniotomy
Dural tenting sutures
Dural tenting techniques
Dural tenting techniques
Applying at least 3 dural tenting sutures during closure of a craniotomy
Interventions
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No dural tenting techniques
Not applying dural tenting sutures during closure of a craniotomy
Dural tenting techniques
Applying at least 3 dural tenting sutures during closure of a craniotomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* qualified for an elective supratentorial craniotomy with a diameter of at least 3 cm
* Glasgow Coma Scale 15 preoperatively
* Modified Rankin Scale 0, 1 or 2 preoperatively
Exclusion Criteria
* Revision craniotomy
* Skull base surgery
18 Years
75 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Łukasz Przepiórka
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Medical University of Warsaw
Przemysław Kunert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Medical University of Warsaw
Locations
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Department of Neurosurgery, 10th Military Research Hospital and Polyclinic
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin
Lublin, Lublin Voivodeship, Poland
Department of Neurosurgery, Medical University of Warsaw
Warsaw, Mazovian, Poland
Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec
Sosnowiec, Silesian Voivodeship, Poland
Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz
Lodz, Łódź Voivodeship, Poland
Countries
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References
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Swayne OB, Horner BM, Dorward NL. The hitch stitch: an obsolete neurosurgical technique? Br J Neurosurg. 2002 Dec;16(6):541-4; discussion 544.
Winston KR. Efficacy of dural tenting sutures. J Neurosurg. 1999 Aug;91(2):180-4. doi: 10.3171/jns.1999.91.2.0180.
Winston KR. Dural tenting sutures in pediatric neurosurgery. Pediatr Neurosurg. 1998 May;28(5):230-5. doi: 10.1159/000028656.
Wadanamby, S. et al., (2016). Is dural hitching necessary to prevent post-operative extradural haemorrhage in craniotomies and craniectomies. Sri Lanka Journal of Surgery. 34(2), pp.11-17. DOI: http://doi.org/10.4038/sljs.v34i2.8262
Przepiorka L, Wojtowicz K, Kujawski S, Wisniewski K, Bobeff EJ, Kruk R, Kulesza B, Fortuniak J, Mroz A, Dunaj P, Kaspera M, Hoppe S, Krystkiewicz K, Kwiecien K, Szczepanek D, Jaskolski DJ, Ladzinski P, Rola R, Furtak J, Trojanowski T, Marchel A, Kunert P. Dural Tenting in Elective Craniotomies: A Randomized Clinical Trial. Neurosurgery. 2025 May 1. doi: 10.1227/neu.0000000000003480. Online ahead of print.
Kunert P, Przepiorka L, Fortuniak J, Wisniewski K, Bobeff EJ, Larysz P, Kruk R, Kulesza B, Szczepanek D, Ladzinski P, Zylkowski J, Kujawski S, Labedzka K, Jaskolski D, Rola R, Trojanowski T, Marchel A. Prophylactic use of dural tenting sutures in elective craniotomies in adults-is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-inferiority trial. Trials. 2021 Apr 12;22(1):273. doi: 10.1186/s13063-021-05201-z.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Website of the clinical trial
Other Identifiers
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KB/106/2018
Identifier Type: -
Identifier Source: org_study_id
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