Trial Outcomes & Findings for Lumbar Drain After Endoscopic Surgery of the Skull Base (NCT NCT03163134)

NCT ID: NCT03163134

Last Updated: 2017-08-16

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 170 participants
• Primary outcome timeframe: 1month
• Results posted on: 2017-08-16

Participant Flow

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.

Participant milestones

Measure	No Lumbar Drain Group Group of patients that did not receive a lumbar drain after surgery	Lumbar Drain Group Group of patients that received a lumbar drain after surgery Lumbar Drain
Overall Study STARTED	85	85
Overall Study COMPLETED	85	85
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lumbar Drain After Endoscopic Surgery of the Skull Base

Baseline characteristics by cohort

Measure	No Lumbar Drain Group n=85 Participants Group of patients that did not receive a lumbar drain after surgery.	Lumbar Drain Group n=85 Participants Group of patients that received a lumbar drain after surgery. Lumbar Drain	Total n=170 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 15.11 • n=5 Participants	51 years STANDARD_DEVIATION 15.49 • n=7 Participants	52 years STANDARD_DEVIATION 15.30 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	56 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment United States	85 Participants n=5 Participants	85 Participants n=7 Participants	170 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	No Lumbar Drain Group n=85 Participants Group of patients that did not receive a lumbar drain after surgery.	Lumbar Drain Group n=85 Participants Group of patients that received a lumbar drain after surgery. Lumbar Drain
Number of Participants With Cerebrospinal Fluid (CSF) Leak	18 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	No Lumbar Drain Group n=85 Participants Group of patients that did not receive a lumbar drain after surgery.	Lumbar Drain Group n=85 Participants Group of patients that received a lumbar drain after surgery. Lumbar Drain
Number of Participants With Postoperative Complications	17 Participants	20 Participants

Adverse Events

No Lumbar Drain Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lumbar Drain Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benita Valappil

University of Pittsburgh

Phone: 412.864.1744

Email: valappilb2@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place