Dural Tenting Sutures in Neurosurgery - is it Necessary?

NCT03658941 | Completed DMC

• 1 other identifier: KB/106/2018
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 5

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.

Conditions

Epidural Hematoma

Keywords

craniotomy; dural tenting suture; epidural hematoma

Outcome Measures

Primary Outcomes (1)

• Reoperation due to epidural hematoma

  Surgery for the postoperative extradural hematoma

  During hospitalization for the surgery, approximately 2 days postoperatively

Secondary Outcomes (7)

• Postoperative 30-day mortality

  30-day postoperatively

• Postoperative 30-day readmission to a neurosurgical or neurological department

  30-day postoperatively

• 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.

• 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

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

Study Arms (2)

No dural tenting sutures

EXPERIMENTAL

No dural tenting techniques

Procedure: No dural tenting techniques

Dural tenting sutures

ACTIVE COMPARATOR

Dural tenting techniques

Procedure: Dural tenting techniques

Interventions

No dural tenting techniques PROCEDURE

Not applying dural tenting sutures during closure of a craniotomy

Also known as: tack-up sutures, hitch-up stitches

No dural tenting sutures

Dural tenting techniques PROCEDURE

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

Also known as: tack-up sutures, hitch-up stitches

Dural tenting sutures

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (5)

Department of Neurosurgery, 10th Military Research Hospital and Polyclinic

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681, Poland

Location

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

Lublin, Lublin Voivodeship, 20-954, Poland

Location

Department of Neurosurgery, Medical University of Warsaw

Warsaw, Mazovian, 02-097, Poland

Location

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

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

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

Lodz, Łódź Voivodeship, 90-153, Poland

Location

Related Publications (6)

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

  PMID: 12617233 BACKGROUND

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

  PMID: 10433304 BACKGROUND

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

  PMID: 9732254 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

  BACKGROUND

• 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.

  PMID: 40310111 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.

  PMID: 33845888 DERIVED

Related Links

• Website of the clinical trial

MeSH Terms

Conditions

Hematoma, Epidural, Spinal

Condition Hierarchy (Ancestors)

Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Łukasz Przepiórka

  Department of Neurosurgery, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Przemysław Kunert, MD, PhD

  Department of Neurosurgery, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. * Access to the randomization code will be strictly controlled. * The surgeon will receive information on subject's allocation after commencing the surgery. The study blind will be broken: 1. During interim monitoring, after recruiting the first 100 patients. 2. On completion of the clinical study and after the study database has been locked. 3. When patients' safety requires access to allocation data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 6, 2018
• Study Start: September 7, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: July 30, 2024

Record last verified: 2019-01

Locations

PL (5)