Dural Tenting Sutures in Neurosurgery - is it Necessary?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prophylactic Use of Dural Tenting Sutures in Elective Craniotomies - is it Necessary? A Multicentre Randomised Study.

Conditions
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Epidural Hematoma

Intervention / Treatment
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* Procedure: No dural tenting techniques
* Procedure: Dural tenting techniques


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We plan to include 2000 subjects in this study. Each subject will undergo a craniotomy for unrelated pathology. Each of the subjects will be assigned in random order to an intervention or control group. The intervention group will not have dural tenting sutures during closure of their craniotomy while the control group will have at least three. Both groups will be followed radiologically and clinically, in the exact same manner.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No dural tenting sutures<br>No dural tenting techniques | Procedure: No dural tenting techniques<br>* Not applying dural tenting sutures during closure of a craniotomy<br>* Other names: hitch-up stitches;|
| Active Comparator: Dural tenting sutures<br>Dural tenting techniques | Procedure: Dural tenting techniques<br>* Applying at least 3 dural tenting sutures during closure of a craniotomy<br>* Other names: hitch-up stitches;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation due to epidural hematoma | Surgery for the postoperative extradural hematoma | During hospitalization for the surgery, approximately 2 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative 30-day mortality | The data to measure postoperative 30-day mortality will be obtained from a national database 30 days after the recruitment of all participants has been completed. | 30-day postoperatively | 
| Postoperative 30-day readmission to a neurosurgical or neurological department | The data required to evaluate readmission rates will be obtained from the hospital databases. | 30-day postoperatively | 
| New neurologic deficit or deterioration of a previous one | New neurologic deficit or deterioration of a preoperative deficit, as evaluated on postoperative day 5-7. | during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day. | 
| Cerebrospinal fluid leak requiring treatment. | Presence of a cerebrospinal fluid leak requiring treatment. | during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day. | 
| Deterioration of postoperative headaches over 5 Numerical Rating Scale | The Numeric Rating Scale is an 11-point scale for patient self-reporting of pain. It ranges from 0 (no pain) to 10 (the worst imaginable pain). There are no subscales. Higher values indicate more pain and, therefore, represent undesirable outcome. | during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day. | 
| Epidural collection thickness over 3 mm measured radiographically | Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists | During hospitalization, approximately 1-3 days postoperatively | 
| Midline shift over 5 mm | Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists | During hospitalization, approximately 1-3 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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craniotomy, dural tenting suture, epidural hematoma