An interventional study of No dural tenting techniques and Dural tenting techniques in Epidural Hematoma, sponsored by Medical University of Warsaw. Completed at 5 sites in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Prevention
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.
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.
20 studies on the registry are indexed under Hematoma, Epidural, Spinal; 5 are open to participants now.
This study's enrollment of 490 is above the median of 151 across 11 interventional studies indexed under Hematoma, Epidural, Spinal.
Browse Hematoma, Epidural, Spinal studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No dural tenting techniques
Procedure: No dural tenting techniques
Dural tenting techniques
Procedure: Dural tenting techniques
Not applying dural tenting sutures during closure of a craniotomy
Also known as: tack-up sutures, hitch-up stitches
Applying at least 3 dural tenting sutures during closure of a craniotomy
Also known as: tack-up sutures, hitch-up stitches
Reoperation due to epidural hematoma
Surgery for the postoperative extradural hematoma
Time frame: During hospitalization for the surgery, approximately 2 days postoperatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: During hospitalization, approximately 1-3 days postoperatively
Midline shift over 5 mm
Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists
Time frame: During hospitalization, approximately 1-3 days postoperatively
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The trial protocol, full study report, anonymised participant-level dataset and statistical code for generating the results will be made publicly available if all investigators agree to share the data.
Ran from Sep 2018 to primary completion in Sep 2021, 35 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Warsaw →