An interventional study of Lumbar Drain in Quality of Life, sponsored by University of Pittsburgh. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention
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.
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.
University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Group of patients that did not receive a lumbar drain after surgery
Group of patients that received a lumbar drain after surgery
Device: Lumbar Drain
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
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
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.
| Milestone | No Lumbar Drain Group | Lumbar Drain Group |
|---|---|---|
| Started | 85 | 85 |
| Completed | 85 | 85 |
| Not completed | 0 | 0 |
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.
| Participants | No Lumbar Drain Group | Lumbar Drain Group |
|---|---|---|
| Number of Participants With Cerebrospinal Fluid (CSF) Leak | 18 | 7 |
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.
| Participants | No Lumbar Drain Group | Lumbar Drain Group |
|---|---|---|
| Number of Participants With Postoperative Complications | 17 | 20 |
Collected over Three times a year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Lumbar Drain Group | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
| Lumbar Drain Group | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
| Age, Continuous(years) | No Lumbar Drain Group | Lumbar Drain Group | Total |
|---|---|---|---|
| Mean | 52 ± 15.11 | 51 ± 15.49 | 52 ± 15.30 |
| Sex: Female, Male(Participants) | No Lumbar Drain Group | Lumbar Drain Group | Total |
|---|---|---|---|
| Female | 49 | 56 | 105 |
| Male | 36 | 29 | 65 |
| Region of Enrollment(Participants) | No Lumbar Drain Group | Lumbar Drain Group | Total |
|---|---|---|---|
| United States | 85 | 85 | 170 |
Plan to share: Undecided
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh