NCT04060186

Postoperative Balloninflation After Evacuation of cSDH

Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver ("Valsalva maneuver") every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.

Conditions

• Chronic Subdural Hematoma

Interventions

Type	Name	Description
PROCEDURE	Balloninflation	Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-08-30
• Completion: 2022-02-28
• First posted: 2019-08-19
• Last updated: 2019-12-20

Locations

1 site across 1 country: Germany