NCT02382692

Brief Summary

Sinus surgery is a common procedure. A potential complication is injuring the membranes of the brain. This can lead to leakage of brain fluid through the nose. We would like to estimate the incident rates of that complication. At the end of the operation, a thin gauze is inserted into the nose on both sides in addition to the usual tampon. This gauze will be analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

March 2, 2015

Last Update Submit

May 3, 2017

Conditions

Cerebrospinal Fluid Leakage

Outcome Measures

Primary Outcomes (1)

  • Beta-2-Transferrin positive or negative

    1 day postoperative

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with indication to a sinus intervention without planned opening of the skull base

You may qualify if:

  • All patients with planned sinus surgery in terms of Ethmoidektomie / Sphenoethmoidektomie or Frontosphenoethmoidektomie
  • Male and female patients aged 18 to 99 years
  • Written consent of the participating person after the enlightenment

You may not qualify if:

  • Olanned or accidental opening of the skull base
  • Tumor in the skull base
  • Pre-existing known rhinoliquorrhoe
  • Lack of understanding the study or investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Soyka MB, Holzmann D. Correlation of complications during endoscopic sinus surgery with surgeon skill level and extent of surgery. Am J Rhinol. 2005 May-Jun;19(3):274-81.

    PMID: 16011134BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA Samples

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 9, 2015

Study Start

February 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)