Dural Tenting Sutures in Neurosurgery - is it Necessary?

Medical University of Warsaw

Status: Completed

Conditions: Epidural Hematoma

Treatments: Procedure: No dural tenting techniques; Procedure: Dural tenting techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT03658941

KB/106/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 490 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 criteria

• Coagulation abnormalities before the surgery
• Revision craniotomy
• Skull base surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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490 participants in 2 patient groups

No dural tenting sutures

Experimental group

Description:

No dural tenting techniques

Treatment:

Procedure: No dural tenting techniques

Dural tenting sutures

Active Comparator group

Description:

Dural tenting techniques

Treatment:

Procedure: Dural tenting techniques