Randomized Controlled Trial Investigating Optimal Treatment for Chronic Subdural Hematoma

NCT02655445 | Completed

• 1 other identifier: UZB-CSDH-1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Setup of comparative trial The goal of this study is to determine whether one surgical treatment for chronic subdural hematoma is better than the other. Patients with a clear indication for drainage of subdural hematoma (as stated under "Surgical options") will be randomized into three groups. One group will receive twist drill craniostomy followed by drainage during 48 hours. One group will undergo burr hole drainage (single if possible, double if necessary) with irrigation and drainage during 48 hours postoperatively. One group will undergo a minicraniotomy with trephine or craniotome, with wide opening of all visible membranes, rigorous irrigation and placement of Jackson-Pratt drain, followed by closed system draining during 48 hours. Postoperative results and complications will be compared between the three groups.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• Reoperation rate

  The 30 day reoperation rate (number of patients reoperated for recurrence or persistence of chronic subdural hematoma) is the primary endpoint

  30 days

Secondary Outcomes (8)

• Mortality

  6 months

• Complications

  From the moment of hospitalisation till the moment of discharge, an expected average of 2 weeks

• duration of operation

  assessment on the day of the surgery; the time duration in minutes from incision (start of the surgery) to finished suturing (end of the surgery) (skin tot skin) is noted

• technical difficulties during operation

  during operation (from incision to finished suturing)

• Duration of hospital stay

  Number of days the patient is hospitalized after the operation, before he is being discharged home or to a rehabilitation center, an expected average of 2 weeks

Study Arms (3)

Mini-craniotomy

ACTIVE COMPARATOR

Intervention: Bone flap \> 30mm and replaced, placement of Jackson-Pratt drain A linear incision located over the biggest bulk of the hematoma is made. Dura is opened and a wide opening of the pseudomembrane is done. A closed system subdural drain (Jackson-Pratt catheter) is inserted after irrigation until clear liquid return

Procedure: Mini-craniotomy

Twist Drill Craniostomy

ACTIVE COMPARATOR

Intervention: twist drill burr hole \<5mm, placement of Integra basket-type drain A stab incision to the scalp is made, at the approximate location of the thickest diameter of hematoma. The twist-drill hole \<5mm is placed obliquely to the surface of the skull, at an angle of about 45° until perforation of the dura. No irrigation is performed. A basket-type drain (Integra) is placed in the subdural space and tunneled underneath the skin

Procedure: Twist Drill Craniostomy

Burr Hole Craniostomy

ACTIVE COMPARATOR

Intervention: 2 Burr Holes \>5mm and \<30mm, placement of Jackson-Pratt drain First burr hole at the site of maximal diameter, second anterior and superior to that point. The scalp incisions are so planned that they can be incorporated into a craniotomy if necessary. Visible membranes are opened with a sharp hook until the pia is visualized. Gentle irrigation is performed and continued until the returning liquid is clear. Two burr holes are placed to facilitate drainage. A closed system subdural drain (Jackson-Pratt catheter) is inserted after irrigation until clear liquid return

Procedure: Burr Hole Craniostomy

Interventions

Mini-craniotomy PROCEDURE

chronic subdural hematoma evacuation through minicraniotomy

Mini-craniotomy

Twist Drill Craniostomy PROCEDURE

chronic subdural hematoma evacuation through twist drill craniostomy

Twist Drill Craniostomy

Burr Hole Craniostomy PROCEDURE

chronic subdural hematoma evacuation through burr holes

Burr Hole Craniostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients with chronic subdural hematoma with indication for surgical intervention: clinical symptoms as a result of the subdural collection, or important mass effect (as indicated by a midline shift of more than 5mm)

You may not qualify if:

• Patients under the age of 18 will be excluded
• Patients who have undergone previous cranial surgery which would limit surgical options (for example bone flap already in place)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

Related Publications (1)

• Duerinck J, Van Der Veken J, Schuind S, Van Calenbergh F, van Loon J, Du Four S, Debacker S, Costa E, Raftopoulos C, De Witte O, Cools W, Buyl R, Van Velthoven V, D'Haens J, Bruneau M. Randomized Trial Comparing Burr Hole Craniostomy, Minicraniotomy, and Twist Drill Craniostomy for Treatment of Chronic Subdural Hematoma. Neurosurgery. 2022 Aug 1;91(2):304-311. doi: 10.1227/neu.0000000000001997. Epub 2022 May 24.

  PMID: 35593710 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Johnny B Duerinck, MD PhD

  Universitair Ziekenhuis Brussel - Neurosurgery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: January 14, 2016
• Study Start: January 1, 2012
• Primary Completion: October 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

BE (1)