Dural Tenting Sutures in Neurosurgery - is it Necessary?

Epidural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03658941
• Other study ID #: KB/106/2018
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2019
• Source: Medical University of Warsaw
• Contact: Przemyslaw Kunert, MD, PhD
• Phone: +48 22 599 25 75
• Email: przemyslaw.kunert[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Hematoma
• Hematoma

Intervention

Procedure:
• No dural tenting techniques
Not applying dural tenting sutures during closure of a craniotomy
• Dural tenting techniques
Applying at least 3 dural tenting sutures during closure of a craniotomy

Locations

Country	Name	City	State
Poland	Department of Neurosurgery, 10th Military Research Hospital and Polyclinic	Bydgoszcz	Kuyavian-pomeranian
Poland	Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz	Lódz	Lódzkie
Poland	5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin	Lublin	Lubelskie
Poland	Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec	Sosnowiec	Slaskie
Poland	Department of Neurosurgery and Pediatric Neurosurgery, Pomeranian Medical University	Szczecin	West Pomeranian
Poland	Department of Neurosurgery, Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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

Winston KR. Dural tenting sutures in pediatric neurosurgery. Pediatr Neurosurg. 1998 May;28(5):230-5. — View Citation

Winston KR. Efficacy of dural tenting sutures. J Neurosurg. 1999 Aug;91(2):180-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation due to epidural hematoma	Surgery for the postoperative extradural hematoma	During hospitalization for the surgery, approximately 2 days postoperatively
Secondary	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
Secondary	Postoperative 30-day readmission to a neurosurgical or neurological department	The data required to evaluate readmission rates will be obtained from the hospital databases.	30-day postoperatively
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Midline shift over 5 mm	Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists	During hospitalization, approximately 1-3 days postoperatively

External Links

•   Website of the clinical trial