Quality of Life
Conditions
Keywords
Lumbar Drain, CSF Leak
Brief summary
The overall purpose of this study was to assess the necessity of lumbar drain placement after endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak postoperatively and promote a standardization of its use.
Detailed description
In the past, reconstructions were performed using fat grafts or fascia lata for EEA surgery. Considerably high postoperative CSF leaks were reported and were a major cause of concern due CSF fistula increasing risk of infection. Since external lumbar drain can lower CSF pressure and is believed to prevent post operative CSF leak, it was used commonly after EEA. With improvements in EEA skull base reconstructions using a nasal septal flap in the recent years, postoperative CSF leaks have been reported in much lower rates. With this improvement in reconstruction techniques, the use of lumbar drain may not be necessary as it may not significantly lower the risk of CSF leak further. In this prospective randomized study, we will randomize subjects at high risk for CSF leak to either receive a prophylactic lumbar drain or to not receive a prophylactic lumbar drain and compare the rate of CSF leaks and other complications in the two groups.
Interventions
DEVICELumbar Drain
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Patients undergoing EEA for resection of brain tumors * Dural defect greater than 1cm * Extensive arachnoid dissection * Dissection into a ventricle or cistern
Exclusion criteria
* Less than 18 years of age * Spina Bifida
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cerebrospinal Fluid (CSF) Leak | 1month | Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Complications | 1 year | Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement. |
Countries
United States
Participant flow
Recruitment details
All adult patients undergoing endoscopic endonasal approach (EEA) at the Center for Cranial Base Surgery of the University of Pittsburgh Medical Center from February 2011 to April 2015 were evaluated for enrollment.
Participants by arm
| Arm | Count |
|---|---|
| No Lumbar Drain Group Group of patients that did not receive a lumbar drain after surgery. | 85 |
| Lumbar Drain Group Group of patients that received a lumbar drain after surgery.
Lumbar Drain | 85 |
| Total | 170 |
Baseline characteristics
| Characteristic | No Lumbar Drain Group | Lumbar Drain Group | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 15.11 | 51 years STANDARD_DEVIATION 15.49 | 52 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment United States | 85 Participants | 85 Participants | 170 Participants |
| Sex: Female, Male Female | 49 Participants | 56 Participants | 105 Participants |
| Sex: Female, Male Male | 36 Participants | 29 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 85 |
| other Total, other adverse events | 0 / 85 | 0 / 85 |
| serious Total, serious adverse events | 0 / 85 | 0 / 85 |
Outcome results
Primary
Number of Participants With Cerebrospinal Fluid (CSF) Leak
Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.
Time frame: 1month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Lumbar Drain Group | Number of Participants With Cerebrospinal Fluid (CSF) Leak | 18 Participants |
| Lumbar Drain Group | Number of Participants With Cerebrospinal Fluid (CSF) Leak | 7 Participants |
p-value: 0.017Chi-squared
Secondary
Number of Participants With Postoperative Complications
Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Lumbar Drain Group | Number of Participants With Postoperative Complications | 17 Participants |
| Lumbar Drain Group | Number of Participants With Postoperative Complications | 20 Participants |
p-value: 0.577Chi-squared