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Randomized Controlled Trial Investigating Optimal Treatment for Chronic Subdural Hematoma

NCT02655445 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-05-19

No results posted yet for this study

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

Interventions

PROCEDURE

Mini-craniotomy

chronic subdural hematoma evacuation through minicraniotomy

PROCEDURE

Twist Drill Craniostomy

chronic subdural hematoma evacuation through twist drill craniostomy

PROCEDURE

Burr Hole Craniostomy

chronic subdural hematoma evacuation through burr holes

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Johnny B Duerinck, MD PhD · Universitair Ziekenhuis Brussel - Neurosurgery Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2019-10-31
Completion
2020-03-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655445 on ClinicalTrials.gov