Comparison of the new three dimensional “3D” with the conventional two dimensional “2D” endoscopic camera in surgery of the paranasal sinuses
| ISRCTN | ISRCTN10446213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10446213 |
| Secondary identifying numbers | BASEC Nr 2018-0005 |
- Submission date
- 14/04/2018
- Registration date
- 26/04/2018
- Last edited
- 31/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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)
Contact information
Scientific
ORL-Zentrum Klinik Hirslanden
Witellikerstrasse 40
Zurich
CH-8032
Switzerland
Study information
| Study design | International multicentre prospective randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN10446213_PIS_23Apr18.docx |
| Scientific title | Comparison of 3D Endoscopy with 2D Endoscopy during functional endoscopic sinus surgery |
| Study objectives | This study aims to compare the standard 2D-endoscopic surgical technique with the new commercially available 3D-endoscopic technique. |
| Ethics approval(s) | Kantonale Ethikkommission Zürich Ch-8090 Zurich Switzerland, 05/04/2018, ref: 2018-00005 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/01/2018 |
| Completion date | 31/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80; 20 at each of the four study centres |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Adult aged 18 years or above 2. Chronic rhinosinusitis 3. Candidate for endoscopic sinus surgery |
| Key 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 |
| Date of first enrolment | 15/02/2019 |
| Date of final enrolment | 11/12/2019 |
Locations
Countries of recruitment
- Austria
- Germany
- Switzerland
Study participating centres
Zurich
Ch-8032
Switzerland
Ulm
89075
Germany
Possartstrasse 27-31
München
8169
Germany
Graz
8036
Austria
Sponsor information
Hospital/treatment centre
Witellikerstrasse 40
Zurich
CH-8032
Switzerland
| Phone | +41 44 387 28 00 |
|---|---|
| briner@orl-Zentrum.com | |
"ROR" |
https://ror.org/014c2qb55 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 23/04/2018 | 01/04/2019 | No | Yes | |
| Protocol file | 23/04/2018 | 01/04/2019 | No | No | |
| Results article | results | 29/12/2020 | 31/12/2020 | Yes | No |
Additional files
- ISRCTN10446213_PIS_23Apr18.docx
- Uploaded 01/04/2019
- ISRCTN10446213_protocol_23Apr18.pdf
- Uploaded 01/04/2019
Editorial Notes
31/12/2020: Publication reference added.
08/01/2020: The total final enrolment number has been added.
12/12/2019: The recruitment end date was changed from 30/11/2019 to 11/12/2019.
06/12/2019: The total final enrolment number has been added.
14/11/2019: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2019 to 30/11/2019.
2. The overall trial end date has been changed from 31/12/2019 to 31/01/2020.
3. The intention to publish date has been changed from 01/12/2020 to 31/01/2021.
05/09/2019: The recruitment end date has been changed from 30/08/2019 to 31/10/2019.
01/04/2019: The participant information sheet and protocol (not peer reviewed) have been uploaded.
10/01/2019: The following changes have been made:
1. The recruitment start date has been updated from 01/05/2018 to 15/02/2019.
2. The recruitment end date has been updated from 01/12/2018 to 30/08/2019.
3. The overall trial end date has been updated from 31/12/2018 to 31/12/2019.
4. The intention to publish date has been updated from 30/06/2019 to 01/12/2020.
