Dural Tenting Sutures in Neurosurgery - is it Necessary?

Last updated: July 29, 2024
Sponsor: Medical University of Warsaw
Overall Status: Completed

Phase

N/A

Condition

Brain Injury

Treatment

Dural tenting techniques

No dural tenting techniques

Clinical Study ID

NCT03658941
KB/106/2018
  • Ages 18-75
  • All Genders

Study Summary

This study evaluates the necessity of dural tenting sutures in craniotomies. The sutures elevate the dura, a layer between the brain and skull. Supposedly, by doing so, they prevent blood collecting between dura mater and the skull. These blood collections, called epidural hematomas, contributed greatly to postoperative mortality in the early days of neurosurgery. There have been several reports questioning the ongoing need for them in neurosurgery, thanks to modern hemostatic techniques. Moreover, it has been published in the literature, and is a common knowledge as well, that some neurosurgeons do not use these sutures at all, and do not have worse outcomes than their colleagues.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female over 18 and under 75 years old

  • 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

Exclusion Criteria:

  • Coagulation abnormalities before the surgery

  • Revision craniotomy

  • Skull base surgery

Study Design

Total Participants: 490
Treatment Group(s): 2
Primary Treatment: Dural tenting techniques
Phase:
Study Start date:
September 07, 2018
Estimated Completion Date:
September 01, 2022

Study Description

In the early days of neurosurgery, epidural hemorrhages (EDH) contributed to a high mortality rate after craniotomies. Almost a century ago Walter Dandy reported dural tenting sutures as an effective way of preventing postoperative EDH. Over time, his technique gained in popularity and significance to finally become a neurosurgical standard.

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.

Connect with a study center

  • Department of Neurosurgery, 10th Military Research Hospital and Polyclinic

    Bydgoszcz, Kuyavian-pomeranian 85-681
    Poland

    Site Not Available

  • 5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin

    Lublin, Lubelskie 20-954
    Poland

    Site Not Available

  • Department of Neurosurgery, Medical University of Warsaw

    Warsaw, Mazovian 02-097
    Poland

    Site Not Available

  • Department of Neurosurgery and Pediatric Neurosurgery, Pomeranian Medical University

    Szczecin, West Pomeranian 71-252
    Poland

    Site Not Available

  • Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz

    Łódź, Łódzkie 90-153
    Poland

    Site Not Available

  • Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec

    Sosnowiec, Śląskie 41-200
    Poland

    Site Not Available

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