Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety

NCT ID: NCT05615506

Last Updated: 2022-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-10-01

Brief Summary

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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

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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.

Conditions

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Adenoidectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients

suction diathermy adenoidectomy

Group Type EXPERIMENTAL

Suction Diathermy Adenoidectomy

Intervention Type PROCEDURE

suction diathermy adenoidectomy

Interventions

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Suction Diathermy Adenoidectomy

suction diathermy adenoidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Amr Hamed Hashem

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amr Hamed Hashem

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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amr h elsherif, resident

Role: CONTACT

01093898351

elhussein a ali, a.professor

Role: CONTACT

Facility Contacts

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amr elsherif

Role: primary

01093898351

References

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

Reference Type RESULT
PMID: 1728896 (View on PubMed)

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.

Reference Type RESULT
PMID: 10582114 (View on PubMed)

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.

Reference Type RESULT
PMID: 9578120 (View on PubMed)

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

Reference Type RESULT
PMID: 17334301 (View on PubMed)

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.

Reference Type RESULT
PMID: 22032788 (View on PubMed)

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

Reference Type RESULT
PMID: 9055172 (View on PubMed)

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.

Reference Type RESULT
PMID: 20950511 (View on PubMed)

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.

Reference Type RESULT
PMID: 27340625 (View on PubMed)

Other Identifiers

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soh-med-22-10-10

Identifier Type: -

Identifier Source: org_study_id

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