The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study
Recruitment status was Not yet recruiting
This is a prospective randomised-controlled multi-centre trial based in Hong Kong to determine whether temporary subdural drain placement after burr hole evacuation of a chronic subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole operative drainage will be randomly allocated into one of two groups: (1) for intra-operative subdural drain placement (intervention group) or (2) not for drain placement (control group). Using web-based software block randomisation with an allocation ratio of 1:1 will be conducted. Instructions to use or not to use a drain will be contained in a sealed envelopes labelled with sequential study numbers.
Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the haematoma the patient's condition is unsafe for drain placement, the subject will be excluded from the study. Otherwise, randomisation will be performed at this juncture by the opening of the sealed envelop. The procedure involves placing a prefabricated silicon drain into the subdural space according to a standard protocol and will be removed on the second post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain placement is unsafe will be excluded from the study. Drainage is undertaken passively by hanging the collection bag at the bedside in a dependent position. In addition to general demographic, clinical and radiological presentation data, potential risk factors for recurrence will be documented. Serial computed tomography brain scans will be arranged (before discharge, at four weeks and six months) and the occurence of significant subdural haematoma recurrence requiring repeat operative drainage at six months will be recorded. Other outcome measures to be determined at regular time intervals for a total follow-up period of six months (upon discharge, at four weeks and six months) include: functional performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added neurological deficit, death and other surgery-related complications. All outcomes will be documented by the trial investigators or by the responsible clinician. The data obtained will be analysed according to the principle of intention to treat.
Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control), the additional placement of a subdural drain after evacuation (intervention) will reduce the risk of recurrence requiring repeat surgery.
Chronic Subdural Hematoma
Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study|
- Significant recurrent chronic subdural hematoma i.e. requiring repeat operative drainage at six months after the primary operation [ Time Frame: Six months after primary burr hole evacuation of chronic subdural hematoma ] [ Designated as safety issue: Yes ]
- 1. Functional performance in terms of the Extended Glasgow Outcome Scale [ Time Frame: Upon discharge, 4 weeks and 6 months after primary operation ] [ Designated as safety issue: No ]
- Added neurological deficit [ Time Frame: Upon discharge, at 4 weeks and 6 months after primary operation ] [ Designated as safety issue: Yes ]
- Surgery-related complications [ Time Frame: Upon discharge, at 4 weeks and 6 months after primary operation ] [ Designated as safety issue: Yes ]
- Death [ Time Frame: Upon discharge, at 4 weeks and 6 months after primary operation ] [ Designated as safety issue: Yes ]
- Modified Rankin Score [ Time Frame: Upon discharge, at 4 weeks and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
No Intervention: Control: burr hole drainage only
Burr hole drainage of chronic subdural hematoma under general or local anesthesia without the subsequent placement of a subdural drain.
Experimental: Intervention: silicon subdural drain
Placement of a silicon subdural drain after burr hole drainage of a chronic subdural hematoma.
|Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785797
|Contact: Peter YM Woo, FRCS (SN)||852+ 3517 2275 ext firstname.lastname@example.org|
|China, Hong Kong|
|Prince of Wales Hospital||Not yet recruiting|
|Hong Kong, Hong Kong, China, N.A.|
|Contact: Peter YM Woo, FRCS (SN) 852+ 3517 2275 ext 2275 email@example.com|