Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety

NCT05615506 | Unknown

• 1 other identifier: soh-med-22-10-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoidectomy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy

  6 months

• Postoperative pain

  7 days

• postoperative halitosis

  7 days

• operative time with suction diathermy adenoidectomy

  6 months

• Speech changes

  6 months

Study Arms (1)

patients

EXPERIMENTAL

suction diathermy adenoidectomy

Procedure: Suction Diathermy Adenoidectomy

Interventions

Suction Diathermy Adenoidectomy PROCEDURE

suction diathermy adenoidectomy

patients

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Amr Hamed Hashem

Sohag, Egypt

RECRUITING

Related Publications (8)

• Gates GA, Muntz HR, Gaylis B. Adenoidectomy and otitis media. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:24-32. doi: 10.1177/00034894921010s106.

  PMID: 1728896 RESULT

• 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.

  PMID: 10582114 RESULT

• 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.

  PMID: 9578120 RESULT

• Shapiro NL, Bhattacharyya N. Cold dissection versus coblation-assisted adenotonsillectomy in children. Laryngoscope. 2007 Mar;117(3):406-10. doi: 10.1097/MLG.0b013e31802ffe47.

  PMID: 17334301 RESULT

• 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.

  PMID: 22032788 RESULT

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

  PMID: 9055172 RESULT

• 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.

  PMID: 20950511 RESULT

• 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.

  PMID: 27340625 RESULT

Central Study Contacts

amr h elsherif, resident

CONTACT

01093898351; elsherifamr99@gmail.com

elhussein a ali, a.professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 14, 2022
• Study Start: October 12, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

EG (1)