Recruiting

Observational Study

Sponsor:

Georgetown University

Code:

NCT03437954

Conditions

Chronic Tonsillitis

Sleep Disordered Breathing

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Interventions

Diet modification

Study Details

Brief summary:

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.

Conditions

Chronic Tonsillitis

Sleep Disordered Breathing

Study ID

NCT03437954

Start date

Dec 15, 2017

Status verified date

Mar, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Standard soft diet

other: Non-restricted diet

Interventions

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.

Primary outcome measure

  • Bleeding [ Time Frame: From time of surgery through postoperative day 10. ]

Central Contacts and Locations

Central contacts

Kelly Scriven, MD

202-444-8186kelly.a.scriven@gmail.com

Earl Harley, MD

202-444-8186harleye@georgetown.edu

Locations

MedStar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Earl Harley, MD

202-444-8186harleye@georgetown.edu

More Information

Sponsor

Georgetown University

Last update posted

Mar 12, 2019

Last verified

Mar, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2019-03-12.