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Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety

S

Sohag University

Status

Enrolling

Conditions

Adenoidectomy

Treatments

Procedure: Suction Diathermy Adenoidectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05615506
soh-med-22-10-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

patients
Experimental group
Description:
suction diathermy adenoidectomy
Treatment:
Procedure: Suction Diathermy Adenoidectomy

Trial contacts and locations

1

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Central trial contact

amr h elsherif, resident; elhussein a ali, a.professor

Data sourced from clinicaltrials.gov

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