Clinical trial NCT05615506: Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety
Official title: Suction Diathermy Adenoidectomy : Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenoidectomy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 40
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the efficacy of suction diathermy in completeness of adenoid removal
timeFrame: intraoperative
measure: amount of intraoperative blood loss with suction diathermy adenoidectomy
timeFrame: intraoperative
measure: Recurrence of symptoms
timeFrame: 6 months
measure: postoperative hemorrhage
timeFrame: 2 weeks
Secondary outcomes:
measure: Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy
timeFrame: 6 months
measure: Postoperative pain
timeFrame: 7 days
measure: postoperative halitosis
timeFrame: 7 days
measure: operative time with suction diathermy adenoidectomy
timeFrame: 6 months
measure: Speech changes
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Amr Hamed Hashem
Study officials:
References:
citation: Gates GA, Muntz HR, Gaylis B. Adenoidectomy and otitis media. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:24-32. doi: 10.1177/00034894921010s106.
citation: Dinis PB, Haider H, Gomes A. The effects of adenoid hypertrophy and subsequent adenoidectomy on pediatric nasal airway resistance. Am J Rhinol. 1999 Sep-Oct;13(5):363-9. doi: 10.2500/105065899781367564.
citation: Clemens J, McMurray JS, Willging JP. Electrocautery versus curette adenoidectomy: comparison of postoperative results. Int J Pediatr Otorhinolaryngol. 1998 Mar 1;43(2):115-22. doi: 10.1016/s0165-5876(97)00159-6.
citation: Shapiro NL, Bhattacharyya N. Cold dissection versus coblation-assisted adenotonsillectomy in children. Laryngoscope. 2007 Mar;117(3):406-10. doi: 10.1097/MLG.0b013e31802ffe47.
citation: Pagella F, Pusateri A, Canzi P, Caputo M, Marseglia A, Pelizzo G, Matti E. The evolution of the adenoidectomy: analysis of different power-assisted techniques. Int J Immunopathol Pharmacol. 2011 Oct;24(4 Suppl):55-9. doi: 10.1177/03946320110240S411.
citation: Wright ED, Manoukian JJ, Shapiro RS. Ablative adenoidectomy: a new technique using simultaneous liquefaction/aspiration. J Otolaryngol. 1997 Feb;26(1):36-43.
citation: Regmi D, Mathur NN, Bhattarai M. Rigid endoscopic evaluation of conventional curettage adenoidectomy. J Laryngol Otol. 2011 Jan;125(1):53-8. doi: 10.1017/S0022215110002100. Epub 2010 Oct 18.
citation: Agrawal V, Agarwal PK, Agrawal A. Defining the Surgical Limits of Adenoidectomy so as to Prevent Recurrence of Adenoids. Indian J Otolaryngol Head Neck Surg. 2016 Jun;68(2):131-4. doi: 10.1007/s12070-016-0971-7. Epub 2016 Mar 12.