NCT03437954

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

January 24, 2018

Last Update Submit

March 8, 2019

Conditions

Chronic TonsillitisSleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

  • Bleeding

    Blood tinged sputum or hemoptysis reported by patient or patient caregiver to on call resident or at post operative appointment; blood clot or bleeding from tonsil bed observed objectively on physical examination.

    From time of surgery through postoperative day 10.

Secondary Outcomes (2)

  • Pain

    From time of surgery through postoperative day 10.

  • Days missed from normal activity

    From time of surgery through postoperative day 10.

Study Arms (2)

Standard soft diet

OTHER
Other: Diet modification

Non-restricted diet

OTHER
Other: Diet modification

Interventions

Diet modificationOTHER

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 dietStandard soft diet

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Earl Harley, MD

    MedStar Georgetown University Hospital

    STUDY DIRECTOR

Central Study Contacts

Kelly Scriven, MD

CONTACT

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

Earl Harley, MD

CONTACT

202-444-8186harleye@georgetown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 19, 2018

Study Start

December 15, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

US(1)