Secretory Otitis Media in Adenoids Hypertrophy Patients

Assiut University

Status: Unknown

Conditions: Otitis Media With Effusion

Treatments: Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

Study type: Interventional

Funder types: Other

Identifiers

NCT04584073

OME in adenoids hypertrophy

Details and patient eligibility

About

This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

Full description

Otitis media with effusion (OME) is one of the most common diseases during childhood . It is defined as collection of non-purulent effusion (mucoid or serous) in the middle ear space without signs of acute infection. It's synomus are serous otitis media, secretory otitis media or glue ear. Adenoid hypertrophy can cause mechanical obstruction of the Eustachian tube which plays an important role in the pathogenesis of OME.

Management of OME consisted of many varieties; 1- Auto inflation, 2- Medical treatment and 3- Surgical. Surgical treatment indicated in cases where the effusion does not resolve spontaneously or failed medical treatment for 3 months and the main purpose of surgery is to restore middle ear aeration. Treatment options are Adenoidectomy with or without Myringotomy or Myringotomy and Tympanostomy tube application.

The aim of this study is to compare the efficacy of each surgical option in management of otitis media with effusion. This study will be carried out in ENT department of Assiut university hospital on 150 child diagnosed as persistent otitis media with effusion due to adenoid enlargement and they will be categorized randomly into three groups (50 cases per each). Group I will undergo Adenoidectomy alone, group II will undergo Adenoidectomy and Myringotomy and group III will undergo Adenoidectomy and Myringotomy and Tympanostomy tube application. All patients will be subjected to full ENT examination and audiological evaluation. Postoperative evaluation will be done for all patients for 3 months through clinical and audiological evaluation.

Enrollment: 150 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any case presented with Secretory Otitis Media with adenoids hypertrophy with the following criteria
• Age is between 3 to 17 years old
• With or without chronic tonsillitis
• conductive hearing loss
• Recurrent upper respiratory tract infection
• Dull tympanic membrane on otoscopy (absent cone of light), decreased mobility of tympanic membrane
• Type B tympanogram on tympanometry
• OME not responding to medical treatment for three months

Exclusion criteria

• Patients with the following criteria will be excluded from the study
• Previous Myringotomy with or without Tympanostomy Tube application
• Previous adenoidectomy or tonsillectomy
• Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups

Adenoidectomy

Active Comparator group

Description:

Adenoidectomy

Treatment:

Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

Adenoidectomy and Myringotomy

Active Comparator group

Description:

Adenoidectomy and Myringotomy

Treatment:

Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

Adenoidectomy,Myringotomy and Tympanostomy tube application

Active Comparator group

Description:

Adenoidectomy and Myringotomy and Tympanostomy tube application

Treatment:

Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application