Subjective and Objective Outcome of ESS in CRSwNP

NCT ID: NCT04868695

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2025-03-01

Brief Summary

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(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.

Detailed Description

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(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.

Conditions

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CRS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bilateral Spheno-Ethmoidectomy:

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Bilateral Fronto-Spheno-Ethmoidectomy + Draf 2b

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Draf Typ 3

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zurich University Hospital

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Michael B Soyka, MD

Role: CONTACT

0432531460

Christian Meerwein, MD

Role: CONTACT

0432531460

Facility Contacts

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Michael Soyka, Dr.med.

Role: primary

+41 44 255 11 11

Other Identifiers

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ID 2020-00322

Identifier Type: -

Identifier Source: org_study_id

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