NCT07856771

Brief Summary

The purpose of this randomized clinical trial is to compare two surgical methods for removing enlarged adenoids in children: conventional curettage adenoidectomy and endoscopic microdebrider-assisted adenoidectomy. Enlarged adenoids can cause problems such as snoring, mouth breathing, obstructive sleep apnea, and changes in facial appearance. The main question this study aims to answer is:

  • Does endoscopic microdebrider-assisted adenoidectomy result in different operative outcomes compared with conventional curettage adenoidectomy? The study will include 88 children aged 3-16 years who have enlarged adenoids and symptoms such as obstructive sleep apnea, mouth breathing, or snoring. Participants will be randomly assigned to one of two groups:
  • Group A: Adenoidectomy using a conventional adenoid curette.
  • Group B: Adenoidectomy using a microdebrider while viewing the adenoids with an endoscope. All procedures will be performed under general anesthesia. The researchers will record the duration of the operation and the amount of blood lost during surgery. These outcomes will be compared between the two groups to determine whether the surgical techniques differ in operative time and blood loss. Parents or guardians will provide informed consent before their child participates in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2026

Completed
Last Updated

October 5, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Adenoid Hypertrophy

Keywords

AdenoidectomyAdenoid HypertrophyEndoscopic AdenoidectomyMicrodebriderCurettage AdenoidectomyPediatric AdenoidectomyObstructive Sleep ApneaSnoringMouth BreathingOperative timeBlood loss

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Blood Loss

    Total blood loss during adenoidectomy, measured from the graduated suction cylinder and by weighing pre-weighed roller packs used in the nasopharynx, with 1 gram of blood equivalent to 1 mL.

    From the start of surgery until completion of adenoidectomy and handover of the patient to the anesthetist for extubation.

Other Outcomes (1)

  • Operative time

    From the start of surgical incision until completion of wound closure

Study Arms (2)

Conventional Curretage Adenoidectomy

ACTIVE COMPARATOR

Participants will undergo conventional adenoidectomy using a St. Clair Thompson adenoid curette under general anesthesia with orotracheal intubation.

Procedure: Conventional Curretage Adenoidectomy

Endoscopic Microdebrider-Assisted Adenoidectomy

EXPERIMENTAL

Participants will undergo adenoidectomy using a microdebrider under endoscopic visualization.

Procedure: Endoscopic Microdebrider-Assisted Adenoidectomy

Interventions

Conventional Curretage AdenoidectomyPROCEDURE

Surgical removal of enlarged adenoid tissue using a St. Clair Thompson adenoid curette under general anesthesia with orotracheal intubation.

Conventional Curretage Adenoidectomy
Endoscopic Microdebrider-Assisted AdenoidectomyPROCEDURE

A 45° angled blade will be introduced through the oropharynx, with irrigation at 15 mL/min and the microdebrider set at 5000 oscillations/second. A zero-degree endoscope will be inserted through either nostril for visualization during the procedure.

Endoscopic Microdebrider-Assisted Adenoidectomy

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • History of obstructive sleep apnea
  • Mouth breathing
  • Snoring
  • Adenoid facies

You may not qualify if:

  • Craniofacial syndromes (cleft lip, cleft palate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSnoringMouth BreathingHemorrhage

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Muhammad W Saleem, FCPS

    Allama Iqbal Teaching Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 5, 2026

Study Start

May 1, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

October 5, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)