Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety (SDA)

Suction Diathermy Adenoidectomy : Efficacy and Safety

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.

Study Overview

• Status: Recruiting
• Conditions: Adenoidectomy
• Intervention / Treatment: Procedure: Suction Diathermy Adenoidectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: amr h elsherif, resident; Phone Number: 01093898351; Email: elsherifamr99@gmail.com
• Study Contact Backup: Name: elhussein a ali, a.professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Amr Hamed Hashem
    • Contact: amr elsherif; Phone Number: 01093898351; Email: elsherifamr99@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients; suction diathermy adenoidectomy	Procedure: Suction Diathermy Adenoidectomy; suction diathermy adenoidectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Gates GA, Muntz HR, Gaylis B. Adenoidectomy and otitis media. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:24-32. Review.
• 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.
• 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.
• Shapiro NL, Bhattacharyya N. Cold dissection versus coblation-assisted adenotonsillectomy in children. Laryngoscope. 2007 Mar;117(3):406-10.
• 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.
• Wright ED, Manoukian JJ, Shapiro RS. Ablative adenoidectomy: a new technique using simultaneous liquefaction/aspiration. J Otolaryngol. 1997 Feb;26(1):36-43.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia
• Other Study ID Numbers: soh-med-22-10-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No