Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety

Adenoidectomy Clinical Trial

— SDA  

Official title:

Suction Diathermy Adenoidectomy : Efficacy and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615506
• Other study ID #: soh-med-22-10-10
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2022
• Source: Sohag University
• Contact: amr h elsherif, resident
• Phone: 01093898351
• Email: elsherifamr99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoidectomy
• Hyperthermia

Intervention

Procedure:
• Suction Diathermy Adenoidectomy
suction diathermy adenoidectomy

Locations

Country	Name	City	State
Egypt	Amr Hamed Hashem	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View 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. — View 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. — View Citation

Gates GA, Muntz HR, Gaylis B. Adenoidectomy and otitis media. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:24-32. Review. — View 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. Review. — View 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. — View Citation

Shapiro NL, Bhattacharyya N. Cold dissection versus coblation-assisted adenotonsillectomy in children. Laryngoscope. 2007 Mar;117(3):406-10. — View Citation

Wright ED, Manoukian JJ, Shapiro RS. Ablative adenoidectomy: a new technique using simultaneous liquefaction/aspiration. J Otolaryngol. 1997 Feb;26(1):36-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	amount of intraoperative blood loss with suction diathermy adenoidectomy	amount of blood loss measured in cubic centimeter	intraoperative
Primary	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
Primary	postoperative hemorrhage	percentage of occurence of post operative hemorrhage	2 weeks
Secondary	Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy	evaluated using zero degree nasal endoscope	6 months
Secondary	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
Secondary	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
Secondary	operative time with suction diathermy adenoidectomy	operative time measured in minutes	6 months
Secondary	Speech changes	detection of open nasality and palatal assessment by Flexible fibre optic nasopharyngoscope after 3 weeks then 3 and 6 months	6 months