Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms

December 5, 2023 updated by: Mohamed Mahmoud Mohamed Ragheb, Assiut University
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed M Roshdy

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • AssiutU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • .all patients with adenoid hypertrophy causing airway obstruction.

Exclusion Criteria:

  • 1. Chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
  • 2 . Systemic medical problems interfering with surgery.
  • 3 . Refusal of parents to participate.
  • 4. Craniofacial abnormalities.
  • 5. Down syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endoscopic total adenoidectomy
Device: Endoscopic adenoidectomy
Subjects will be randomly assigned into two groups (30 patient each group): Group A will undergo endoscopic partial adenoidectomy using the 70◦ rigid endoscope trans-orally and shaver (microdebrider) ,by removing the upper (choanal) part only with leaving the lower part of the adenoid .(2) Group B will undergo total adenoidectomy ,by removing all the adenoid lymphoid tissue .
Active Comparator: Endoscopic partial adenoidectomy
Device: Endoscopic adenoidectomy
Subjects will be randomly assigned into two groups (30 patient each group): Group A will undergo endoscopic partial adenoidectomy using the 70◦ rigid endoscope trans-orally and shaver (microdebrider) ,by removing the upper (choanal) part only with leaving the lower part of the adenoid .(2) Group B will undergo total adenoidectomy ,by removing all the adenoid lymphoid tissue .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
Time Frame: 1 to 2 years .
1. Relief of nasal obstruction while preserving the function of velopharyngeal valve and assessment of the recurrence rate.
1 to 2 years .
Incidence of recurrence using fibro-optic evaluation
Time Frame: 1 to 2 years .
Relief of nasal obstruction of posterior nasal chona using fibro-optic evaluation and assessment of recurrence rate using also questionnaires sheets to all parents.
1 to 2 years .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endoscopic adenoidectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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