NCT07745868

Brief Summary

Nasal obstruction is a common problem in children and is frequently caused by adenoid hypertrophy with concomitant inferior turbinate hypertrophy, leading to sleep-disordered breathing and reduced quality of life. Although adenoidectomy is the standard treatment, persistent nasal obstruction may occur in some patients due to inferior turbinate enlargement. Recent evidence suggests that combining inferior turbinate reduction with adenoidectomy may provide superior relief of nasal obstruction and improve postoperative outcomes compared with adenoidectomy alone. The study aims to compare the effectiveness of adenoidectomy alone versus adenoidectomy combined with endoscopic bilateral partial inferior turbinectomy in relieving nasal obstruction and sleep-disordered breathing in children with adenoid and bilateral inferior turbinate hypertrophy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 4, 2026

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • operative time

    operative duration in mintues

    During the procedure

  • nasal obstruction

    pre and post operative difeerence of nasal obstruction using nose score

    preoperative till 2 months after opertaions

Study Arms (2)

patients presneted with adenoid hypertrophy

ACTIVE COMPARATOR

Patients who presented with adenoid hypertrophy and underwent adenoidectomy by curettage assisted by endoscopic suction coagulation

Procedure: adenoidectomy

patients who presnted with adneoid hypereophy assicated with bilateral nferior turbiante hypertrophy

ACTIVE COMPARATOR

Patients who present with adenoid hypertrophy and bilateral inferior turbinate hypertrophy will undergo adenoidectomy by currattage, assisted by endoscopic suction coagulation and bilateral partial inferior turbinectomy

Procedure: Adenodiectomy and bilateral partial infeiror turbienctomy

Interventions

adenoidectomyPROCEDURE

Adenoidectomy by currattage assisted by suction coagulation

patients presneted with adenoid hypertrophy

adenodiectomy by currattage assisted by suction coagulation and bilateral partial inferior turbienctomy

patients who presnted with adneoid hypereophy assicated with bilateral nferior turbiante hypertrophy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age : children (9 - 18 years old ) only.
  • Patients with bilateral nasal obstruction or sleep-disordered breathing, and having adenoid hypertrophy diagnosed by nasal endoscopy, with bilateral inferior turbinate hypertrophy investigated by CT and confirmed by endoscopy despite 3 months of medical treatment with intranasal corticosteroid and oral antihistaminic.
  • Sex : both males and females.
  • Patients were selected from the otorhinolaryngology outpatient clinic of Al-Azhar University hospital in Assiut in a consecutive manner.
  • All patients were generally well and fit for surgery.

You may not qualify if:

  • Patients with recent upper respiratory tract infection.
  • Evidence of any bleeding disorders .
  • Patients with serous otitis media and chronic tonsillitis.
  • patients contraindicated to do adenoidectomy after phoniatric consultation.
  • patients with atrophic rhinitis
  • patients with nasal obstruction due to other causes such as : deviated nasal septum and antrochoanal polyp.
  • Patients with sinonasal pathology like a marked septal deviation or nasal polyposis, and those exhibiting symptoms that could indicate chronic or recurrent rhinosinusitis, such as fever, headaches, facial pain, rhinorrhea, antibiotic requirements, and purulence seen on nasal endoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar university Hopital in Assiut

Asyut, Egypt

Location

MeSH Terms

Interventions

Adenoidectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ENT specialist

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

September 1, 2025

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

August 4, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations