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Epidural HematomaNCT03658941

Dural Tenting Sutures in Neurosurgery - is it Necessary?

A study testing No dural tenting techniques and Dural tenting techniques in people with Epidural Hematoma, run by Medical University of Warsaw at 5 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Epidural Hematoma
What is being tested?
No dural tenting techniques and Dural tenting techniques
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
490 participants
Where
5 sitesPoland
Study dates
7 Sep 2018to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Coagulation abnormalities before the surgery
  • Revision craniotomy
  • Skull base surgery

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Poland5 sites

  • Department of Neurosurgery, 10th Military Research Hospital and Polyclinic

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681

  • Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz

    Lodz, Łódź Voivodeship, 90-153

  • 5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin

    Lublin, Lublin Voivodeship, 20-954

  • Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec

    Sosnowiec, Silesian Voivodeship, 41-200

  • Department of Neurosurgery, Medical University of Warsaw

    Warsaw, Mazovian, 02-097

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
No dural tenting techniques, Dural tenting techniques
Keywords
craniotomy, dural tenting suture, epidural hematoma
Medical subject headings
Hematoma, Epidural, Spinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No dural tenting techniquesProcedure or surgery

    Also called tack-up sutures, hitch-up stitches

    Not applying dural tenting sutures during closure of a craniotomy

  • Dural tenting techniquesProcedure or surgery

    Also called tack-up sutures, hitch-up stitches

    Applying at least 3 dural tenting sutures during closure of a craniotomy

Study groups in NCT03658941
Study groupRoleWhat they receive
No dural tenting suturesExperimentalNo dural tenting techniques
Receives: Procedure: No dural tenting techniques
Dural tenting suturesActive comparatorDural tenting techniques
Receives: Procedure: Dural tenting techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reoperation due to epidural hematoma

    Surgery for the postoperative extradural hematoma

    Measured: During hospitalization for the surgery, approximately 2 days postoperatively

Secondary outcomes (7)

  1. 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.

    Measured: 30-day postoperatively

  2. Postoperative 30-day readmission to a neurosurgical or neurological department

    The data required to evaluate readmission rates will be obtained from the hospital databases.

    Measured: 30-day postoperatively

  3. 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.

    Measured: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.

  4. Cerebrospinal fluid leak requiring treatment.

    Presence of a cerebrospinal fluid leak requiring treatment.

    Measured: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.

  5. 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.

    Measured: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.

  6. Epidural collection thickness over 3 mm measured radiographically

    Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists

    Measured: During hospitalization, approximately 1-3 days postoperatively

  7. Midline shift over 5 mm

    Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists

    Measured: During hospitalization, approximately 1-3 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start7 Sep 2018
  3. Primary completion1 Sep 2021
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
490 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03658941
Sponsor's protocol ID
KB/106/2018
Status last verified
Jan 2019
First submitted
31 Aug 2018
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Swayne OB, Horner BM, Dorward NL. The hitch stitch: an obsolete neurosurgical technique? Br J Neurosurg. 2002 Dec;16(6):541-4; discussion 544.

    PubMed 12617233

  • Winston KR. Efficacy of dural tenting sutures. J Neurosurg. 1999 Aug;91(2):180-4. doi: 10.3171/jns.1999.91.2.0180.

    PubMed 10433304

  • Winston KR. Dural tenting sutures in pediatric neurosurgery. Pediatr Neurosurg. 1998 May;28(5):230-5. doi: 10.1159/000028656.

    PubMed 9732254

  • 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

  • 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.

    PubMed 40310111

  • 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.

    PubMed 33845888

Questions about this trial

What is this clinical trial studying?

A study testing No dural tenting techniques and Dural tenting techniques in people with Epidural Hematoma, run by Medical University of Warsaw at 5 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reoperation due to epidural hematoma (time frame: During hospitalization for the surgery, approximately 2 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658941, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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