Dural Tenting Sutures in Neurosurgery - is it Necessary?
- Conditions
- Epidural Hematoma
- Interventions
- Procedure: No dural tenting techniquesProcedure: Dural tenting techniques
- Registration Number
- NCT03658941
- Lead Sponsor
- Medical University of Warsaw
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 490
- 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
- Coagulation abnormalities before the surgery
- Revision craniotomy
- Skull base surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No dural tenting sutures No dural tenting techniques No dural tenting techniques Dural tenting sutures Dural tenting techniques Dural tenting techniques
- Primary Outcome Measures
Name Time Method Reoperation due to epidural hematoma During hospitalization for the surgery, approximately 2 days postoperatively Surgery for the postoperative extradural hematoma
- Secondary Outcome Measures
Name Time Method New neurologic deficit or deterioration of a previous one during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day. New neurologic deficit or deterioration of a preoperative deficit, as evaluated on postoperative day 5-7.
Postoperative 30-day readmission to a neurosurgical or neurological department 30-day postoperatively The data required to evaluate readmission rates will be obtained from the hospital databases.
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. Presence of a cerebrospinal fluid leak requiring treatment.
Postoperative 30-day mortality 30-day postoperatively 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.
Deterioration of postoperative headaches over 5 Numerical Rating Scale during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day. 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.
Epidural collection thickness over 3 mm measured radiographically During hospitalization, approximately 1-3 days postoperatively Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists
Midline shift over 5 mm During hospitalization, approximately 1-3 days postoperatively Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists
Trial Locations
- Locations (5)
Department of Neurosurgery, Medical University of Warsaw
🇵🇱Warsaw, Mazovian, Poland
5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin
🇵🇱Lublin, Lubelskie, Poland
Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec
🇵🇱Sosnowiec, Śląskie, Poland
Department of Neurosurgery, 10th Military Research Hospital and Polyclinic
🇵🇱Bydgoszcz, Kuyavian-pomeranian, Poland
Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz
🇵🇱Łódź, Łódzkie, Poland