Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| semirigid thoracoscopy | Experimental | Semirigid instrument which we compare was autoclavable Olympus LTF-160 (Olympus Tokyo, Japan). Handle and its controls were similar to flexible fiberoptic bronchoscope, with the insertion portion composed of 22 cm long rigid part and distal 5 cm flexible tip with angulation range 1600 up / 1300 down. The external diameter of insertion portion was 7 mm with 2,8 mm inner channel diameter. The instrument was compatible with Olympus EVIS Exera 160 and 145 and EVIS 100 and 140 video processors and light sources, otherwise employed in video-bronchoscopy. Forceps, which we used was flexible FB-55CD-1 Olympus forceps with 5 mm long cusps and diameter, which fitted the diameter of inner channel of semirigid thoracoscope. |
|
| rigid thoracoscopy | Active Comparator | The rigid instrument was autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope. The length of the instrument was 29 cm with 00 direction of view and 700 field of view. The external diameter of the instrument was 10 mm with 5,2 mm inner channel diameter. The instrument was compatible with Olympus Visera OTV-S7V and EVIS Exera II CV-180 video processors. Cusps of rigid forceps had outer diameter 5 mm and length 10 mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semirigid thoracoscopy | Device | thoracoscopy with semirigid instrument |
|
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic adequacy of semirigid thoracoscopy |
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety | Major adverse events:
Minor adverse events:
| 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Golnik | Golnik | Golnik | 4204 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23418922 | Derived | Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| rigid thoracoscopy | Device | thoracoscopy with rigid instrument |
|
|