Adenoid Hypertrophy
Conditions
Keywords
adenoidectomy, adenoids, curettage
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECurettage adenoidectomy with transoral endoscopic ablation
Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue.
PROCEDUREConventional cold curettage adenoidectomy
Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients within 3-12 years old * Patients undergoing tonsillectomy and adenoidectomy for obstructive sleep disorder * Patients undergoing adenoidectomy and ventilation tube insertion for chronic otitis media with effusion (OME) * Patients undergoing adenoidectomy alone for obstructive sleep disorder * Patients undergoing adenoidectomy alone for chronic OME * Patients undergoing adenoidectomy alone for chronic sinusitis
Exclusion criteria
* Patients not between 3-12 years old * Patients with craniofacial anomalies * Revision adenoidectomy * Proven significant comorbidities * Systemic diseases * Bleeding diathesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual adenoid tissue evaluation with Parikh grade | 1 year after surgery | Endoscopic examination of adenoid tissue postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | Up to 2 weeks after surgery | The frequency of postoperative bleeding complication |
| Otitis media with effusion | Up to 1 year after surgery | Persistency and recurrence of OME after adenoidectomy |
Countries
Turkey (Türkiye)
Outcome results
None listed