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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No dural tenting sutures | Experimental | No dural tenting techniques |
|
| Dural tenting sutures | Active Comparator | Dural tenting techniques |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No dural tenting techniques | Procedure | Not applying dural tenting sutures during closure of a craniotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation due to epidural hematoma | Surgery for the postoperative extradural hematoma | During hospitalization for the surgery, approximately 2 days postoperatively |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Łukasz Przepiórka | Department of Neurosurgery, Medical University of Warsaw | Principal Investigator |
| Przemysław Kunert, MD, PhD | Department of Neurosurgery, Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, 10th Military Research Hospital and Polyclinic | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-681 | Poland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12617233 | Background | Swayne OB, Horner BM, Dorward NL. The hitch stitch: an obsolete neurosurgical technique? Br J Neurosurg. 2002 Dec;16(6):541-4; discussion 544. | |
| 10433304 | Background | Winston KR. Efficacy of dural tenting sutures. J Neurosurg. 1999 Aug;91(2):180-4. doi: 10.3171/jns.1999.91.2.0180. |
| Label | URL |
|---|---|
| Website of the clinical trial | View source |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2020 | Jan 14, 2020 | Prot_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2020 | Jan 14, 2020 | SAP_006.pdf |
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| ID | Term |
|---|---|
| D046748 | Hematoma, Epidural, Spinal |
| ID | Term |
|---|---|
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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Due to the nature of the surgical procedures, the surgeon and the rest of the OR medical team will be aware of the current subject's allocation. However, in each case, the specific OR team aware of the subject's allocation will be different from the investigators performing further evaluation of the given subject. The following study procedures will be in place to ensure double-blind administration of the study.
The study blind will be broken:
| Dural tenting techniques | Procedure | Applying at least 3 dural tenting sutures during closure of a craniotomy |
|
|
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 |
| 5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin |
| Lublin |
| Lublin Voivodeship |
| 20-954 |
| Poland |
| Department of Neurosurgery, Medical University of Warsaw | Warsaw | Mazovian | 02-097 | Poland |
| Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec | Sosnowiec | Silesian Voivodeship | 41-200 | Poland |
| Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz | Lodz | Łódź Voivodeship | 90-153 | Poland |
| 9732254 | Background | Winston KR. Dural tenting sutures in pediatric neurosurgery. Pediatr Neurosurg. 1998 May;28(5):230-5. doi: 10.1159/000028656. |
| Background | Wadanamby, S. et al., (2016). Is dural hitching necessary to prevent post-operative extradural haemorrhage in craniotomies and craniectomies. Sri Lanka Journal of Surgery. 34(2), pp.11-17. DOI: http://doi.org/10.4038/sljs.v34i2.8262 |
| 40310111 | Derived | Przepiorka L, Wojtowicz K, Kujawski S, Wisniewski K, Bobeff EJ, Kruk R, Kulesza B, Fortuniak J, Mroz A, Dunaj P, Kaspera M, Hoppe S, Krystkiewicz K, Kwiecien K, Szczepanek D, Jaskolski DJ, Ladzinski P, Rola R, Furtak J, Trojanowski T, Marchel A, Kunert P. Dural Tenting in Elective Craniotomies: A Randomized Clinical Trial. Neurosurgery. 2025 Nov 1;97(5):1108-1117. doi: 10.1227/neu.0000000000003480. Epub 2025 May 1. |
| 33845888 | Derived | Kunert P, Przepiorka L, Fortuniak J, Wisniewski K, Bobeff EJ, Larysz P, Kruk R, Kulesza B, Szczepanek D, Ladzinski P, Zylkowski J, Kujawski S, Labedzka K, Jaskolski D, Rola R, Trojanowski T, Marchel A. Prophylactic use of dural tenting sutures in elective craniotomies in adults-is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-inferiority trial. Trials. 2021 Apr 12;22(1):273. doi: 10.1186/s13063-021-05201-z. |