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technical and funding issues
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This prospective study is designed to compare short and long term results of conventional cold curettage adenoidectomy in children performed without doing any endoscopic or mirror examination before ending the operation versus when combined with transoral endoscopic residue ablation using a wand.
Residual or recurrent adenoid tissue that causes persistence or recurrence of symptoms is observed frequently after conventional cold curettage adenoidectomy. New techniques to better visualize or excise the tissue in order to prevent this situation are being developed. This study aims to compare transoral endoscopic controlled adenoidectomy with conventional blind curettage adenoidectomy in terms of recurrent adenoid hypertrophy. Although there are other studies comparing the results of the two techniques in terms of early residual adenoid tissue and bleeding, no studies comparing the long term results were found in literature. This prospective study is planned to focus on both early examination of residual tissue and long term recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Curettage Adenoidectomy | Active Comparator | Adenoidectomy with Beckmann Adenoid Curette |
|
| Curettage Adenoidectomy With Transoral Endoscopic Ablation | Experimental | Transoral endoscopic adenoidectomy with Coblator 2 system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curettage adenoidectomy with transoral endoscopic ablation | Procedure | Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual adenoid tissue evaluation with Parikh grade | Endoscopic examination of adenoid tissue postoperatively | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | The frequency of postoperative bleeding complication | Up to 2 weeks after surgery |
| Otitis media with effusion | Persistency and recurrence of OME after adenoidectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beldan Polat | Istanbul University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Istanbul Faculty of Medicine | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30885281 | Result | Bidaye R, Vaid N, Desarda K. Comparative analysis of conventional cold curettage versus endoscopic assisted coblation adenoidectomy. J Laryngol Otol. 2019 Apr;133(4):294-299. doi: 10.1017/S0022215119000227. Epub 2019 Mar 19. |
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One group will receive conventional cold curettage adenoidectomy treatment while the other group will receive curettage adenoidectomy with transoral endoscopic residue ablation treatment. The patients operated on Tuesdays and Fridays will receive the first treatment while on Mondays and Thursdays the second treatment.
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The patients are not going to be given the detail about the days, so that they would not know which group they would be in. Care provider and investigator would not know which patient is going to be operated on which day. Outcome assessor would not know which patient received which treatment while examining for the long term results.
| Conventional cold curettage adenoidectomy | Procedure | Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue. |
|
| Up to 1 year after surgery |