Chronic TonsillitisNCT03437954
Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
A study testing Diet modification in people with Chronic Tonsillitis and Sleep Disordered Breathing, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Chronic Tonsillitis, Sleep Disordered Breathing
- What is being tested?
- Diet modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Earl Harley, MD, 202-444-8186, harleye@georgetown.edu
About this study
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.
Read the detailed description
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
- Chronic Tonsillitis, Sleep Disordered Breathing
- Being tested
- Diet modification
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard soft diet | Other | Not described Receives: Other: Diet modification |
| Non-restricted diet | Other | Not described Receives: Other: Diet modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of surgery through postoperative day 10.
Secondary outcomes (2)
Pain
Patient or patient caregiver report of pain at each post operative day using a validated Wong Baker FACES pain scale.
Measured: From time of surgery through postoperative day 10.
Days missed from normal activity
Patient or patient care giver reported number of days spent absent from normal activity as noted at post operative visit.
Measured: From time of surgery through postoperative day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Dec 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TonsillitisStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Earl Harley, MD, Study director, MedStar Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437954
- Sponsor's protocol ID
- Georgetown_Univeristy_MC
- Status last verified
- Mar 2019
- First submitted
- 24 Jan 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
- ClinicalTrials.gov ID
- NCT03437954
- Acronym / sponsor ID
- Georgetown_Univeristy_MC
- Conditions
- Chronic Tonsillitis, Sleep Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard soft diet | Other | Other: Diet modification |
| Non-restricted diet | Other | Other: Diet modification |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet modificationPatients 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. | Other | Non-restricted diet, Standard soft diet |
Primary outcome
Bleeding
Time frame: From time of surgery through postoperative day 10.
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.
2 secondary outcomes
Pain
Time frame: From time of surgery through postoperative day 10.
Days missed from normal activity
Time frame: From time of surgery through postoperative day 10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
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The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earl Harley, MD study director
MedStar Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet modification in people with Chronic Tonsillitis and Sleep Disordered Breathing, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Scriven, MD (202-444-8186, kelly.a.scriven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: From time of surgery through postoperative day 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.