Clinical trial NCT03658941: Dural Tenting Sutures in Neurosurgery - is it Necessary?
Official title: Prophylactic Use of Dural Tenting Sutures in Elective Craniotomies - is it Necessary? A Multicentre Randomised Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Hematoma
Keywords: craniotomy
dural tenting suture
epidural hematoma
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reoperation due to epidural hematoma
timeFrame: During hospitalization for the surgery, approximately 2 days postoperatively
Secondary outcomes:
measure: Postoperative 30-day mortality
timeFrame: 30-day postoperatively
measure: Postoperative 30-day readmission to a neurosurgical or neurological department
timeFrame: 30-day postoperatively
measure: New neurologic deficit or deterioration of a previous one
timeFrame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.
measure: Cerebrospinal fluid leak requiring treatment.
timeFrame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.
measure: Deterioration of postoperative headaches over 5 Numerical Rating Scale
timeFrame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.
measure: Epidural collection thickness over 3 mm measured radiographically
timeFrame: During hospitalization, approximately 1-3 days postoperatively
measure: Midline shift over 5 mm
timeFrame: During hospitalization, approximately 1-3 days postoperatively
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Neurosurgery, 10th Military Research Hospital and Polyclinic
state: Kuyavian-pomeranian
city: Lublin
country: Poland
facility: 5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin
state: Lubelskie
city: Warsaw
country: Poland
facility: Department of Neurosurgery, Medical University of Warsaw
state: Mazovian
city: Łódź
country: Poland
facility: Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz
state: Łódzkie
city: Sosnowiec
country: Poland
facility: Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec
state: Śląskie
Study officials:
affiliation: Department of Neurosurgery, Medical University of Warsaw
name: Łukasz Przepiórka
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, Medical University of Warsaw
name: Przemysław Kunert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swayne OB, Horner BM, Dorward NL. The hitch stitch: an obsolete neurosurgical technique? Br J Neurosurg. 2002 Dec;16(6):541-4; discussion 544.
citation: Winston KR. Efficacy of dural tenting sutures. J Neurosurg. 1999 Aug;91(2):180-4. doi: 10.3171/jns.1999.91.2.0180.
citation: Winston KR. Dural tenting sutures in pediatric neurosurgery. Pediatr Neurosurg. 1998 May;28(5):230-5. doi: 10.1159/000028656.
citation: 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
citation: 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.