Condition category
Respiratory
Date applied
14/04/2018
Date assigned
26/04/2018
Last edited
23/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic rhinosinusitis is a common disease in which the cavities around the nasal passages become swollen. This may lead to a significant impairment of the quality of life in individuals suffering from the disorder. Medical therapy is the treatment of choice to reduce the symptoms. In severe disease, however, medical therapy may not be sufficient to control the disease activity and symptoms. In these cases, surgical therapy is indicated. The principle of surgical therapy is to open the narrow and blocked drainage pathways of the nasal sinuses and therefore to restore clearance of mucus and widen the access for medical treatment such as sprays. This procedure is known as “Functional Endoscopic Sinus Surgery” (FESS). Modern technology helps reduce the potential risks of FESS such as injury of the eye, the optic nerve, the important carotid artery and the brain which are neighbouring the paranasal sinuses. A key component of this endoscopic surgery of the paranasal sinuses is the long thin flexible tube, with a light source (endoscope) and camera which enables a good visualisation of the surgical area. The actual standard technique of endoscopic visualisation is using endoscopes combined with a high resolution camera, providing a 2-dimensional (2D) picture on a high resolution screen. A new development is recently commercially available providing a 3-dimensional picture, which gives additional information of “depth” in the surgical field. The visualisation of a 3-dimensional surgical field has the potential advantage to provide the surgeon with more realistic information about the anatomy of the surgical field which may be beneficial for surgical control and even reducing complications.
This study aims to compare the standard 2D-endoscopic surgical technique with the new commercially available 3D-endoscopic technique.

Who can participate?
Adult aged 18 years or above with chronic rhinosinusitis

What does the study involve?
As participant of the study, a standard sinus surgery procedure is performed, as indicated for the treatment of the chronic rhinosinusitis, one side with the 2D endoscope, the other with the 3D endoscope. The time taken for each side is measured, as well as the subjective impression of the surgeon using the endoscopes.

What are the possible benefits and risks of participating?
There are no additional risks or benefits for the participants involved in this study
Where is the study run from?
1. ORL-Zentrum Klinik Hirslanden (Switzerland)
2. HNO-Universitätsklinik Ulm (Germany)
3. HNO-Klinik München Bogenhausen (Germany)
4. HNO-Universitätsklinik Graz (Austria)

When is the study starting and how long is it expected to run for?
January 2018 to December 2018

Who is funding the study?
ORL-Zentrum Klinik Hirslanden (Switzerland)

Who is the main contact?
Dr Hans Rudolf Briner (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hans Rudolf Briner

ORCID ID

Contact details

ORL-Zentrum Klinik Hirslanden
Witellikerstrasse 40
Zurich
CH-8032
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BASEC Nr 2018-0005

Study information

Scientific title

Comparison of 3D Endoscopy with 2D Endoscopy during functional endoscopic sinus surgery

Acronym

Study hypothesis

This study aims to compare the standard 2D-endoscopic surgical technique with the new commercially available 3D-endoscopic technique.

Ethics approval

Kantonale Ethikkommission Zürich Ch-8090 Zurich Switzerland, 05/04/2018, ref: 2018-00005

Study design

International multicentre prospective randomized interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic rhinosinusitis

Intervention

A total of 80 patients with chronic rhinosinusitis are evaluated. A Functional endoscopic sinus surgery (FESS) procedure is performed. All participants receive the 2D-endoscopic technique on one side, and 3D-endioscopic technique on the other side. In the first of the 20 patients, the side which is operated by the 2D-endoscope is determined by hazard (Los). In the further patients, the side is alternated after each patient.
There are four individual rhinosurgeons at four centers operating and evaluating 20 patients each.
The centers are Graz (Prof. V. Tomazic), Austria, Munich (Prof. A. Leunig), Germany, Ulm (PD Dr. F. Sommer), Germany and Zurich (KD Dr. H.R. Briner), Switzerland.
There is only the measurement of time of the procedure using the 2D and the 3D camera on each side during the procedure which is performed. Additionally, a questionnaire is filled by the surgeon asking for subjective impressions using the 2D or 3D camera. This questionnaire is designed for this study in order to look for subjective differences of the camera techniques. There is no follow up for the study after the procedure.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Time of procedure is measured for 2D and 3D techniques during FESS procedure

Secondary outcome measures

The impressions of the surgeon on both 2D and 3D techniques are measured using a structured surgeon’s questionnaire at the end of the procedure.

Overall trial start date

01/01/2018

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult aged 18 years or above
2. Chronic rhinosinusitis
3. Candidate for endoscopic sinus surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80; 20 at each of the four study centres

Participant exclusion criteria

1. Age below 18 years
2. Previous sinus operations
3. Unilateral or asymmetric disease
4. Severe comorbidities such as bleeding disorders
5. Inability or unwillingness to give consent for the study

Recruitment start date

01/05/2018

Recruitment end date

01/12/2018

Locations

Countries of recruitment

Austria, Germany, Switzerland

Trial participating centre

ORL-Zentrum Klinik Hirslanden
Witellikerstrasse 40
Zurich
Ch-8032
Switzerland

Trial participating centre

HNO-Universitätsklinik Ulm
Frauensteige 12
Ulm
89075
Germany

Trial participating centre

HNO-Klinik München Bogenhausen
Dr. Gaertner GmbH Possartstrasse 27-31
München
8169
Germany

Trial participating centre

HNO-Universitätsklinik Graz
Auenbruggerplatz 1
Graz
8036
Austria

Sponsor information

Organisation

ORL-Zentrum Klinik Hirslanden

Sponsor details

Witellikerstrasse 40
Zurich
CH-8032
Switzerland
+41 44 387 28 00
briner@orl-Zentrum.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

ORL-Zentrum Klinik Hirslanden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

30/06/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes