Randomized control study designed to compare the results and outcomes of topical intranasal steroid spray against surgical adenoidectomy in children with chronic adenoiditis
Not Applicable
Completed
- Conditions
- Health Condition 1: null- patients with chronic adenoiditis
- Registration Number
- CTRI/2017/02/007914
- Lead Sponsor
- K F KAMMAR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Adenoid enlargement grade 2 & 3.
2.Age between 6-15 yrs.
3.Willing for regular follow up
4.Cases of chronic adenoiditis with or without SOM
5.Patient who give consent for either of the group of treatment
6.Immuno-competent
7.Non recurrent cases
8.Patients co-operative for DNE.
9.Patients eligible for either groups of treatment
Exclusion Criteria
1.Acute adenoiditis
2.Enlargement of any other components of waldeyer ring other than adenoids
3.Adenoid obstructing choana completely.(grade 1V) and minimally enlarged adenoid (grade 1)
4.Mentally retarded.
5.Recurrence of adenoid after previous surgery & steroid spray.
6.Symptoms of allergy/ high A E C.
7.Rhinosinusitis with post nasal drip
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Adenoid size and presence as assessed by diagnostic nasal endoscopy (DNE). <br/ ><br>2. Improvement of signs and symptoms (mouth breathing, snoring, nasal obstruction -VAS, recurrent cold, epistaxis, hyponasal speech) <br/ ><br>3. Recurrence & residual disease after treatment assessed by DNE. <br/ ><br>Timepoint: Three assessment followups during post intervention period <br/ ><br>1.one month <br/ ><br>2. three month <br/ ><br>3. six month
- Secondary Outcome Measures
Name Time Method 1 .Hearing improvement <br/ ><br>2. Other Ear symptoms improvement (Earache-VAS) <br/ ><br>3. Disappearance of fluid from middle ear <br/ ><br>4. Complications of treatment in any of the groups. <br/ ><br>5. Any of the treatment groups requiring rescue medication. <br/ ><br>Timepoint: Three assessment followups during post intervention period <br/ ><br>1.one month <br/ ><br>2. three month <br/ ><br>3. six month