Dural Tenting Sutures in Neurosurgery - is it Necessary?

January 20, 2020 updated by: Medical University of Warsaw

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Kuyavian-pomeranian
      • Bydgoszcz, Kuyavian-pomeranian, Poland, 85-681
        • Recruiting
        • Department of Neurosurgery, 10th Military Research Hospital and Polyclinic
        • Contact:
          • Kamil Krystkiewicz, MD
          • Phone Number: 261 417 093
        • Principal Investigator:
          • Marek Harat, MD, PhD
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-954
        • Recruiting
        • 5 Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin
        • Contact:
          • Radosław Rola, MD, PhD
          • Phone Number: +48 81 724 41 76
        • Sub-Investigator:
          • Dariusz Szczepanek, MD, PhD
        • Sub-Investigator:
          • Tomasz Trojanowski, MD, PhD
        • Sub-Investigator:
          • Radosław Rola, MD, PhD
    • Mazovian
      • Warsaw, Mazovian, Poland, 02-097
        • Recruiting
        • Department of Neurosurgery, Medical University of Warsaw
        • Contact:
    • West Pomeranian
      • Szczecin, West Pomeranian, Poland, 71-252
        • Recruiting
        • Department of Neurosurgery and Pediatric Neurosurgery, Pomeranian Medical University
        • Contact:
          • Leszek Sagan, MD, PhD
          • Phone Number: 91 425 35 61
        • Principal Investigator:
          • Leszek Sagan, MD, PhD
    • Łódzkie
      • Łódź, Łódzkie, Poland, 90-153
        • Recruiting
        • Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz
        • Contact:
          • Jan Fortuniak, MD
          • Phone Number: +48 42 677 67 82
        • Sub-Investigator:
          • Jan Fortuniak, MD, PhD
        • Sub-Investigator:
          • Karol Wiśniewski, MD
        • Sub-Investigator:
          • Dariusz Jaskólski, MD, PhD
    • Śląskie
      • Sosnowiec, Śląskie, Poland, 41-200
        • Recruiting
        • Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec
        • Contact:
          • Patrycja Larysz, MD, PhD
          • Phone Number: +48 32 368 25 51
        • Sub-Investigator:
          • Patrycja Larysz, MD, PhD
        • Sub-Investigator:
          • Piotr Ładziński, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No dural tenting sutures
No dural tenting techniques
Procedure: No dural tenting techniques
Not applying dural tenting sutures during closure of a craniotomy
Other Names:
  • tack-up sutures
  • hitch-up stitches
Active Comparator: Dural tenting sutures
Dural tenting techniques
Procedure: Dural tenting techniques
Applying at least 3 dural tenting sutures during closure of a craniotomy
Other Names:
  • tack-up sutures
  • hitch-up stitches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation due to epidural hematoma
Time Frame: During hospitalization for the surgery, approximately 2 days postoperatively
Surgery for the postoperative extradural hematoma
During hospitalization for the surgery, approximately 2 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative 30-day mortality
Time Frame: 30-day postoperatively
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
Time Frame: 30-day postoperatively
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
Time Frame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.
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.
Time Frame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.
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
Time Frame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.
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
Time Frame: During hospitalization, approximately 1-3 days postoperatively
Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists
During hospitalization, approximately 1-3 days postoperatively
Midline shift over 5 mm
Time Frame: During hospitalization, approximately 1-3 days postoperatively
Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists
During hospitalization, approximately 1-3 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Łukasz Przepiórka, Department of Neurosurgery, Medical University of Warsaw
  • Principal Investigator: Przemysław Kunert, MD, PhD, Department of Neurosurgery, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2018

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 20, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/106/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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