Subperiosteal vs Subdural Drain After Burr-

Hole
Drainage of Chronic Subdural Hematoma:
A Randomized Clinical Trial (cSDH-Drain-
Trial)
Resident
Nico Odolf Yordanius

Supervisor
Prof. DR. Dr. Sri Maliawan SpBS(K)
Content
Background
Methods
Intervention
Result
Discussion
Background
cSDH is one of the most common neuro- surgical entities

which effects mostly elderly people and is associated with
substantial morbidity and mortality

Recurrence rate after burr-hole drainage of cSDH is estimated


at approximately 10%
Background
A randomized controlled trial by Santarius (2009) and colleagues
 demonstrated that the
insertion of a subdural drain (SDD) left in situ after burr-hole evacuation significantly
reduces cSDH recurrence requiring redrainage (9.3% vs 24.0% recurrence with vs without
drain )

Most surgeons still prefer the insertion of SDD over SPD after burr-hole drainage of cSDH


The aim of study : investigate recurrence rate after insertion of an SPD is non-inferior to the

insertion of an SDD in patients undergoing surgical evacuation of cSDH through burr-hole
drainage
Methods
Design:
prospective, randomized, controlled, multicenter, non-inferiority, clinical trial in
patients with symptomatic cSDH indicating surgical evacuation
The trial was done and analyzed according to the CONSORT guidelines, and
ethical approval was obtained from the local ethics committee

 Trial Registration
 The trial is registered with ClinicalTrials.gov, number NCT01869855
Methods
Participant
Male or Female age over 18 Years Old
Symptomatic cSDH diagnosed by computed tomography (CT) and/or magnetic
resonance imaging, indicating surgical evacuation of the hematoma

Exclusion Criteria:
 Patients with other surgery indications (craniotomy due to subacute hematoma,
membranes, etc )
 with cSDHs caused by a previous underlying condition (eg, over drainage of a

ventriculoperitoneal shunt
 without informed consent
Intervention
All patients received two-burr-hole trephination
A drain (SPD or SDD ) without suction.
Prophylactic anticonvulsant medication was not applied
A single shot of antibiotics (Cefuroxim) 30 min prior to skin incision
Drilled two 13 mm burr-holes
About 7 to 8 cm apart from each other over the maximum width of the
hematoma
The dura mater was opened with a cruciate incision and coagulated
Subdural hematoma was then washed out with warm saline
 Intervention
Insertion of Drain (SDD or SPD)
Bilateral hematomas were treated
as one case; both sides received
the same treatment
Outcomes
Primary outcome was recurrence of cSDH indicating revision surgery within
12 mo of the original drainage procedure
Recurrence was defined as occurrence of symptoms attributable to an
ipsilateral hematoma seen on CT scan
Secondary outcome measurements included :
medical and surgical complications, reoperation rates (other than surgery for
recurrent cSDH), mortality, clinical outcome measured by Glasgow Coma
Scale (GCS), modified Rankin Scale (mRS), Glasgow Outcome Scale (GOS),
and Markwalder score, length of hospital stay, and radiological characteristics
of postoperative CT images including hematoma width, midline shift (MLS),
drain misplacement, and intracranial hemorrhage other than recurrent cSDH
Outcomes
Clinical follow-up examination 24 h after surgery
6 wk and 12 mo after surgery
Sampel Size
threshold for non-inferiority of SPD for the primary outcome at less than
3.5% difference from SDD in the percentage of recurrence after burr-hole
drainage of cSDH
Randomization
 randomization with blocks of 30 in a 1:1 allocation ratio by a web-based
independent randomization software (Random Allocation version 1.0)
 Instruction on which drain (SDD or SPD) was to be used was kept in sealed

opaque envelopes labeled with sequential study numbers and opened at

surgery, right before the insertion of the drain
Trial Profile
Characteristic
Discussion
 This data shows that the insertion of an SPD causes at most 5.3% more recurrences compared to the insertion of
an SDD
 Overall surgical morbidity and overall mortality did not significantly differ between the SPD and SDD groups
 Significantly more surgical infections and injury of brain parenchyma through misplaced drains in the SDD group
 SDD patients suffered more surgical infections and iatrogenic brain injuries, it did not seem to affect outcome
measurements (mRS, GOS, Markwalder score) or mortality
 Significant benefit for the insertion of SPD for the prevention of surgical infections and iatrogenic brain injuries
(while the fact that this did not influence the outcomes might be random)
 Seizure rates did not differ significantly between the two groups. (patients were monitored clinically and not
through postoperative electroencephalogram)
 Analysis of patients treated with blood thinners showed no significant difference in recurrent rates of cSDH
between thetwo drain groups
Result
Limitation
The number of crossovers within the groups
Estimated recurrence rate of 7.0% was lower than the actual overall
recurrence rate of 10%
Conclusion
We conclude that the insertion of SPD after burr-hole drainage of cSDH
is an efficient and safe alternative to the insertion of an SDD
Recurrence rates of cSDH after inserting an SPD are comparable to
SDD
Surgical infection rates and the occurrence of iatrogenic brain injuries
are significantly reduced
These findings suggest that SPD can be used in routine clinical practice.
Thank You