TonsillectomyEarly Phase 1NCT00730340
Closure Method Study Following Tonsillectomy in Children
A Early Phase 1 study testing Closure of the Tonsillar Fossa and Tonsillectomy with open fossa in people with Tonsillectomy and Children, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Tonsillectomy, Children
- What is being tested?
- Closure of the Tonsillar Fossa and Tonsillectomy with open fossa
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2010
- Phase
- Early Phase 1
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Normal children between that ages of five to ten requiring a tonsillectomy
Who cannot join
- Children older than ten years of age.
- Those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Decreased Morbidity With Closure of the Tonsillar Fossae
This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.
Read the detailed description
This is a children's study. Patients experience significant postoperative pain, activity limitation and sometimes other significant postoperative complications. We are going to compare the effects of closing the tonsil wound versus non-closure. A daily journal will be kept (by the patient's parent or legal guardian)to log in measures of morbidity. Postoperative telephone calls will be made and scripted questions will be asked regarding any tonsillar hemorrhage requiring medical re-evaluation, and dehydration requiring medical re-evaluation. The patients will also be examined in the clinic at 10-14 days postoperatively to determine if the fossa remained closed or dehisced.
- Conditions
- Tonsillectomy, Children
- Being tested
- Closure of the Tonsillar Fossa, Tonsillectomy with open fossa
- Keywords
- Tonsillectomy, tonsillar fossa, wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the Tonsillar FossaProcedure or surgery
We hypothesize that closure of the tonsillar fossa decreases the morbidity of pain by decreasing exposure of the raw operative bed to oral secretions, mediation, and oral intake, and decreases the morbidity of post-operative hemorrhage by having the operative wound closed.
Tonsillectomy with open fossaProcedure or surgery
SOP for a tonsillectomy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients will receive closure of the tonsillar fossae following tonsillectomy. Receives: Procedure: Closure of the Tonsillar Fossa |
| 2 | Active comparator | Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy Receives: Procedure: Tonsillectomy with open fossa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure
Measured: 6 months
Secondary outcomes (1)
The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced.
Measured: 10-14 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Investigators
- Wayne E Berryhill, M.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730340
- Sponsor's protocol ID
- Tonsillar Closure_Berryhill
- Status last verified
- Jun 2010
- First submitted
- 5 Aug 2008
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Morbidity With Closure of the Tonsillar Fossae
- ClinicalTrials.gov ID
- NCT00730340
- Acronym / sponsor ID
- Tonsillar Closure_Berryhill
- Conditions
- Tonsillectomy, Children
- Keywords
- Tonsillectomy, tonsillar fossa, wound closure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Aug 2008 (estimated)
- 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 is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.
Detailed description
This is a children's study. Patients experience significant postoperative pain, activity limitation and sometimes other significant postoperative complications. We are going to compare the effects of closing the tonsil wound versus non-closure. A daily journal will be kept (by the patient's parent or legal guardian)to log in measures of morbidity. Postoperative telephone calls will be made and scripted questions will be asked regarding any tonsillar hemorrhage requiring medical re-evaluation, and dehydration requiring medical re-evaluation. The patients will also be examined in the clinic at 10-14 days postoperatively to determine if the fossa remained closed or dehisced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Closure of the Tonsillar FossaPatients will receive closure of the tonsillar fossae following tonsillectomy. |
| 2 | Active comparator | Procedure: Tonsillectomy with open fossaPatients will not receive closure to one or both tonsillar fossa following a tonsillectomy |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Normal children between that ages of five to ten requiring a tonsillectomy
Key exclusion criteria (2 listed)
- Children older than ten years of age.
- Those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.
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 |
|---|---|---|
| Closure of the Tonsillar FossaWe hypothesize that closure of the tonsillar fossa decreases the morbidity of pain by decreasing exposure of the raw operative bed to oral secretions, mediation, and oral intake, and decreases the morbidity of post-operative hemorrhage by having the operative wound closed. | Procedure or surgery | 1 |
| Tonsillectomy with open fossaSOP for a tonsillectomy. | Procedure or surgery | 2 |
Primary outcome
Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure
Time frame: 6 months
1 secondary outcome
The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced.
Time frame: 10-14 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
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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.
Wayne E Berryhill, M.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Closure of the Tonsillar Fossa and Tonsillectomy with open fossa in people with Tonsillectomy and Children, run by University of Oklahoma 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 2 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: finished, as of the sponsor's last update on 15 Jun 2010. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure (time frame: 6 months). 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 15 Jun 2010.