Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety
- Conditions
- Adenoidectomy
- Interventions
- Procedure: Suction Diathermy Adenoidectomy
- Registration Number
- NCT05615506
- Lead Sponsor
- Sohag University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patients Suction Diathermy Adenoidectomy suction diathermy adenoidectomy
- Primary Outcome Measures
Name Time Method the efficacy of suction diathermy in completeness of adenoid removal intraoperative Flexible fibre optic nasopharyngoscope or zero degree nasal endoscope is used for evaluation of the nasopharynx and determine the adenoid remnant in percentage.
amount of intraoperative blood loss with suction diathermy adenoidectomy intraoperative amount of blood loss measured in cubic centimeter
postoperative hemorrhage 2 weeks percentage of occurence of post operative hemorrhage
Recurrence of symptoms 6 months 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
- Secondary Outcome Measures
Name Time Method Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy 6 months evaluated using zero degree nasal endoscope
postoperative halitosis 7 days 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
operative time with suction diathermy adenoidectomy 6 months operative time measured in minutes
Postoperative pain 7 days 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.
Speech changes 6 months detection of open nasality and palatal assessment by Flexible fibre optic nasopharyngoscope after 3 weeks then 3 and 6 months
Trial Locations
- Locations (1)
Amr Hamed Hashem
🇪🇬Sohag, Egypt