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Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety

Suction Diathermy Adenoidectomy : Efficacy and Safety

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615506
Acronym
SDA
Enrollment
40
Registered
2022-11-14
Start date
2022-10-12
Completion date
2023-10-01
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoidectomy

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.

Interventions

PROCEDURESuction Diathermy Adenoidectomy

suction diathermy adenoidectomy

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No

Inclusion criteria

1. Obstructive symptoms such as long-lasting nocturnal snoring, sleep apnea, and open mouth breathing, bilateral nasal obstruction, and/or bilateral nasal discharge. 2. Adenoid hypertrophy is the only cause of nasal obstruction. 3. Radiography evidence of adenoid hypertrophy encroaching on the airway column. 4. Age under 15 years. 5. Sex: both males and females. 6. All patients are generally well and fit for surgery.

Exclusion criteria

1. Presence of chronic diseases such as chronic heart diseases, chronic liver diseases, chronic renal diseases, and diabetes mellitus. 2. 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). 3. Cases with submucous cleft palate and cases with a previous history of cleft palate repair. 4. Patients with bleeding or coagulation defects. 5. Patients with atrophic rhinitis. 6. Patients with recurrent adenoid.

Design outcomes

Primary

MeasureTime frameDescription
the efficacy of suction diathermy in completeness of adenoid removalintraoperativeFlexible 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 adenoidectomyintraoperativeamount of blood loss measured in cubic centimeter
Recurrence of symptoms6 monthsFlexible 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
postoperative hemorrhage2 weekspercentage of occurence of post operative hemorrhage

Secondary

MeasureTime frameDescription
postoperative halitosis7 dayshalitosis 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
Speech changes6 monthsdetection of open nasality and palatal assessment by Flexible fibre optic nasopharyngoscope after 3 weeks then 3 and 6 months
Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy6 monthsevaluated using zero degree nasal endoscope
Postoperative pain7 dayspain 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.
operative time with suction diathermy adenoidectomy6 monthsoperative time measured in minutes

Countries

Egypt

Contacts

Primary Contactamr h elsherif, resident
elsherifamr99@gmail.com01093898351
Backup Contactelhussein a ali, a.professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026