NCT04868695

Brief Summary

(A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der mittleren Nasenmuschel. (B): Beidseitige Fronto-Spheno-Ethmoidektomie mit maximaler Erweiterung des Zuganges zur Stirnhöhle (Draf Typ III): Unter einem Draf Typ III verste. (C) Beidseitige Spheno-Ethmoidektomie: Abtragung des Processus uncinatus, die Eröffnung der Kieferhöhle, die Eröffnung des vorderen und hinteren Siebbeinsystems und die Eröffnung der Keilbeinhöhle.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3.9 years

First QC Date

April 27, 2021

Last Update Submit

May 7, 2024

Conditions

CRS

Outcome Measures

Primary Outcomes (1)

  • Nasal Polyp Score

    Nasal Polyps

    12 months

Study Arms (3)

Bilateral Spheno-Ethmoidectomy:

EXPERIMENTAL
Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3

Bilateral Fronto-Spheno-Ethmoidectomy + Draf 2b

EXPERIMENTAL
Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3

Draf Typ 3

EXPERIMENTAL
Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3

Interventions

1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3PROCEDURE

1\) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3

Bilateral Fronto-Spheno-Ethmoidectomy + Draf 2bBilateral Spheno-Ethmoidectomy:Draf Typ 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic CRSwNP patients without improvement after conservative treatment for at least 6 months Extent of disease at least Davos Polyp Score ≥ 4 points Age 18-65 years Signed consent

You may not qualify if:

  • Previous sinunasal surgery High resolution paranasal sinus CT shows other pathology (e.g. mucocele) Incapable of judgement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University Hospital

Zurich, 8091, Switzerland

RECRUITING

Central Study Contacts

Michael B Soyka, MD

CONTACT

0432531460rhinologie@usz.ch

Christian Meerwein, MD

CONTACT

0432531460rhinologie@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 3, 2021

Study Start

April 1, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

CH(1)