Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy

NCT ID: NCT03437954

Last Updated: 2019-03-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-12-31

Brief Summary

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This research is being done because it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

Detailed Description

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Currently it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. Traditional standard of care is to recommend that patients be restricted to a soft diet post-operatively. However, the investigators believe that there may be benefit in allowing patients to eat a restriction-free diet. In this study, the investigators will compare the current standard of care verse a non-restricted diet. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

Conditions

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Chronic Tonsillitis Sleep Disordered Breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Standard soft diet

Group Type OTHER

Diet modification

Intervention Type OTHER

Patients will be randomized to follow the standard post-tonsillectomy diet at our institution, which consists of soft foods for ten days, or will be in the non-restricted diet group following surgery.

Non-restricted diet

Group Type OTHER

Diet modification

Intervention Type OTHER

Patients will be randomized to follow the standard post-tonsillectomy diet at our institution, which consists of soft foods for ten days, or will be in the non-restricted diet group following surgery.

Interventions

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Diet modification

Patients will be randomized to follow the standard post-tonsillectomy diet at our institution, which consists of soft foods for ten days, or will be in the non-restricted diet group following surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.

Exclusion Criteria

\-
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Earl Harley, MD

Role: STUDY_DIRECTOR

MedStar Georgetown University Hospital

Locations

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MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelly Scriven, MD

Role: CONTACT

202-444-8186

Earl Harley, MD

Role: CONTACT

202-444-8186

Facility Contacts

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Earl Harley, MD

Role: primary

202-444-8186

Other Identifiers

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Georgetown_Univeristy_MC

Identifier Type: -

Identifier Source: org_study_id

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