Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety

Study Overview
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Brief Summary
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The aim of this prospective study is to evaluate the efficacy and safety of endoscopic suction diathermy adenoidectomy as regard the operative time, adenoid tissue remnant, blood loss, and clinical events like pain, halitosis, postoperative hemorrhage, speech changes and recurrence.

Detailed Description
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Suction diathermy adenoidectomy is a procedure that uses thermal energy generated by electric current to ablate adenoid which is removed using suction. This procedure was described in 1997 and the technique has the advantage of complete tissue removal with reduced blood loss and intraoperative time, also reduced post-operative complications as postoperative hemorrhage , nasality and lower recurrence rate.

Official Title
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Suction Diathermy Adenoidectomy : Efficacy and Safety

Conditions
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Adenoidectomy

Intervention / Treatment
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* Procedure: Suction Diathermy Adenoidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstructive symptoms such as long-lasting nocturnal snoring, sleep apnea, and open mouth breathing, bilateral nasal obstruction, and/or bilateral nasal discharge. Adenoid hypertrophy is the only cause of nasal obstruction. Radiography evidence of adenoid hypertrophy encroaching on the airway column. Age under 15 years. Sex: both males and females. All patients are generally well and fit for surgery. Exclusion Criteria: Presence of chronic diseases such as chronic heart diseases, chronic liver diseases, chronic renal diseases, and diabetes mellitus. Patients with other causes of nasal obstruction such as acute rhinitis, allergic rhinitis, septal deviation, inferior turbinate hypertrophy, antrochoanal polyp, nasal polypi or anatomical deformities (Choanal atresia). Cases with submucous cleft palate and cases with a previous history of cleft palate repair. Patients with bleeding or coagulation defects. Patients with atrophic rhinitis. Patients with recurrent adenoid.

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients under 15 years old who are scheduled to undergo elective adenoidectomy with or without ventilation tube application. , selected randomly, with symptoms and signs suggestive of adenoid hypertrophy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>suction diathermy adenoidectomy | Procedure: Suction Diathermy Adenoidectomy<br>* suction diathermy adenoidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficacy of suction diathermy in completeness of adenoid removal | Flexible fibre optic nasopharyngoscope or zero degree nasal endoscope is used for evaluation of the nasopharynx and determine the adenoid remnant in percentage. | intraoperative | 
| amount of intraoperative blood loss with suction diathermy adenoidectomy | amount of blood loss measured in cubic centimeter | intraoperative | 
| Recurrence of symptoms | Flexible fibre optic nasopharyngoscope or 0 degree nasal endoscope is used for evaluation of the nasopharynx to detect any remnant or recurrence of adenoid in percentage | 6 months | 
| postoperative hemorrhage | percentage of occurence of post operative hemorrhage | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy | evaluated using zero degree nasal endoscope | 6 months | 
| Postoperative pain | pain is assessed using postoperative diary and pain is rated on a 0-10 visual analogue scale, 0 being no pain; and 10 being worse pain ever. | 7 days | 
| postoperative halitosis | halitosis is assessed using postoperative diary and halitosis is rated on 0-10 visual analogue scale, 0 being no odour, and 10 being the worst odour they have encountered | 7 days | 
| operative time with suction diathermy adenoidectomy | operative time measured in minutes | 6 months | 
| Speech changes | detection of open nasality and palatal assessment by Flexible fibre optic nasopharyngoscope after 3 weeks then 3 and 6 months | 6 months |