Clinical Trial: Randomized Controlled Trial Investigating Optimal Treatment for Chronic Subdural Hematoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Compact Trial - A Randomized Controlled Trial Investigating Optimal Treatment for Chronic Subdural Hematoma

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.

Detailed Summary:

Study design The study is set up as an open randomized controlled three-arm trial. Patients will be randomized into three groups.

Study setup and procedures The goal of this study is to determine if 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 to 96 hours. One group will undergo burr hole drainage (single if possible, double if necessary) with irrigation and drainage during 48 to 96 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 drainage during 48 to 96 hours.

Patients diagnosed with chronic subdural hematoma on CT scan, will be operated on as soon as possible. The type of operation will be determined by randomization. The duration of surgery as well as presence of brain reexpansion (in case of burr hole or minicraniotomy) will be recorded. Postoperatively, patients will be transferred to the neurosurgery ward with a subdural drainage system in place. Drainage system is removed 48 to 96 hours postoperatively, regardless of the type of operation (48 hours standard; longer period of drainage if drainage less than 50cc/24h evaluated on the second 24 hours postoperatively. Maximal time of continuous drainage is 4 days or 96 hours postoperatively). Drained volume will be recorded. Evaluation will be performed preoperatively, 48h postoperatively, on discharge, after 6 weeks and after 6 months, and will include:

• Age, sex, comorbiditie
  Sponsor: Universitair Ziekenhuis Brussel
  

  Current Primary Outcome: Reoperation rate [ Time Frame: 30 days ]

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

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Mortality [ Time Frame: 6 months ]
  • Complications [ Time Frame: From the moment of hospitalisation till the moment of discharge, an expected average of 2 weeks ]
    Medical and surgical complications during the patient's hospital stay will be registered.
  • duration of operation [ Time Frame: 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 ]
    duration of operation in minutes
  • technical difficulties during operation [ Time Frame: during operation (from incision to finished suturing) ]
    technical difficulties will be assessed by the operating surgeon (yes/no followed by a description of the encountered difficulties)
  • Duration of hospital stay [ Time Frame: 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 ]
    Duration of hospital stay in days
  • Improvement of Clinical status and speed thereof [ Time Frame: 6 months ]
    Patients will be followed for six months postoperatively. Improvement of clinical status will be recorded by registering the Markwalder scale preoperatively, at discharge, at six weeks and at six months postoperatievely. Speed of improvement will be recorded as the first moment where the highest score on the clinical outcome scale has been reached
  • Improvement of Clinical status and speed thereof 2 [ Time Frame: 6 months ]
    Patients will be followed for six months postoperatively. Improvement of clinical status will be recorded by registering the Modified Rankin scale preoperatively, at discharge, at six weeks and at six months postoperatievely. Speed of improvement will be recorded as the first moment where the highest score on the clinical outcome scale has been reached
  • Improvement of CT-imaging characteristics (Measurement of the largest diameter of the subdural hematoma) [ Time Frame: 6 months ]
    preoperatively, two days postoperatively, at discharge, at six weeks and at six months postoperatively.
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Universitair Ziekenhuis Brussel
  

  Dates:
  Date Received: December 9, 2014
  Date Started: January 2012
  Date Completion: December 2018
  Last Updated: January 11, 2016
  Last Verified: December 2015