NCT03163134

Lumbar Drain After Endoscopic Surgery of the Skull Base

Terminated NA Results posted Last updated 16 August 2017

What this trial tests

NA trial testing Lumbar Drain in Quality of Life in 170 participants. Terminated before completion.

Timeline

3 February 2011

Primary endpoint
27 April 2015

27 April 2015

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	170
Start date	3 February 2011
Primary completion	27 April 2015
Estimated completion	27 April 2015
Sites	1 location across United States

Drugs / interventions tested

• Lumbar Drain

Conditions studied

• Quality of Life — all drugs for Quality of Life →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Cerebrospinal Fluid (CSF) Leak Primary · 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.

Group	Value	95% CI
No Lumbar Drain Group	18
Lumbar Drain Group	7

Number of Participants With Postoperative Complications Secondary · 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.

Group	Value	95% CI
No Lumbar Drain Group	17
Lumbar Drain Group	20

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Does lumbar drainage reduce postoperative cerebrospinal fluid leak after endoscopic endonasal skull base surgery? A prospective, randomized controlled trial.
   Zwagerman NT, Wang EW, Shin SS, Chang YF, et al · · 2019 · cited 118× · PMID 30485224 · DOI 10.3171/2018.4.jns172447