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

NCT ID: NCT06169384

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-06-01

Brief Summary

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Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.

Detailed Description

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Conditions

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Adenoidal Hypertrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Endoscopic total adenoidectomy

Group Type ACTIVE_COMPARATOR

Endoscopic adenoidectomy

Intervention Type DEVICE

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 .

Endoscopic partial adenoidectomy

Group Type ACTIVE_COMPARATOR

Endoscopic adenoidectomy

Intervention Type DEVICE

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 .

Interventions

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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 .

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Mahmoud Mohamed Ragheb

Resident investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AssiutU

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed M Ragheb

Role: CONTACT

Phone: 01010058868

Email: [email protected]

Mohamed M Roshdy

Role: CONTACT

References

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1. Jervis-Bardy, J.; Department of Otolaryngology, Arkansas Children's Hospital, cLittle Rock, AR, United States. Journal of Craniofacial SurgeryVolume 30, Issue 5, Pages E454 - E4602019.

Reference Type BACKGROUND

1. Kummer AW, Lee L. Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 27:271-281

Reference Type BACKGROUND

Saunders NC, Hartley BE, Sell D, Sommerlad B. Velopharyngeal insufficiency following adenoidectomy. Clin Otolaryngol Allied Sci. 2004 Dec;29(6):686-8. doi: 10.1111/j.1365-2273.2004.00870.x.

Reference Type BACKGROUND
PMID: 15533160 (View on PubMed)

Other Identifiers

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Endoscopic adenoidectomy

Identifier Type: -

Identifier Source: org_study_id