Endoscopic assisted transoral endonasal adenoidectomy using microdebrider vs coblator : A comparative study
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr Arunabha Sengupta
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Clinical improvement in breathing
Overview
Brief Summary
Adenoidectomy is one of the most common procedures performed in paediatric otorhinolaryngology either alone or in conjunction with tonsillectomy or insertion of ventilation tubes or grommets. Although adenoidectomy is conventionally
done by curettage method by curetting the adenoid tissue blindly using St. Clair Thompson adenoid curette, newer methods including the use of suction diathermy, electrocautery, laser, coblation and endoscopic adenoidectomy is gaining popularity in modern times. Of these endoscopic adenoidectomy using power assisted Microdebrider adenoidectomy and Coblation adenoidectomy are the two new techniques available for adenoidectomy these days and are most commonly practiced in recent times. The advantages of endoscopic power assisted adenoidectomy over cold steel adenoidectomy has been well established in the literature. As adenoidectomy is one of the common paediatric surgical procedure there is always a concern to improve the outcomes and make postoperative experience more pleasant for the paediatric population. This study will look into the clinical outcomes following endoscopic assisted adenoidectomy by comparison between the two surgical methods by parameters like intraoperative time, intra-operative blood loss and post-operative pain, recovery time (ability to take solid food), residual tissue, post operative clinical improvement in breathing impact on hearing between the two methods.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient having Grade III or Grade IV adenoid hypertrophy, with or without bilateral tonsillar enlargement, with symptoms affecting speech, swallowing, breathing or sleep and having received at least one course of antibiotics.
- •2.Symptoms hampering day-to-day activities of patient.
- •3.Patients willing to participate in the study after giving informed consent.
- •4.Patients having no other debilitating systemic disease.
Exclusion Criteria
- •1.Age less than 3yrs and more than 15yrs.
- •2.Grade I or grade II disease.
- •3.Revision cases.
- •4.Patients with any debilitating systemic disease.
- •5.Cleft palate.
- •5.Cranio-facial abnormalities.
Outcomes
Primary Outcomes
Clinical improvement in breathing
Time Frame: 1 Month | 3 Month | 6 Month
Secondary Outcomes
- Impact in Hearing Outcomes(1 Month)
Investigators
Payal Pandey
Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital