Obstructive Sleep Disordered BreathingNCT03475329
Adeno-tonsillectomy in Treatment of Obstructive Sleep Apnea
An observational study of Obstructive Sleep Disordered Breathing, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate adenoidectomy with bilateral partial tonsillectomy compared with adenoidectomy with classical unilateral complete tonsillectomy for management of pediatric Obstructive Sleep-Disordered Breathing (OSDB) in terms of efficacy of the technique and reducing postoperative complications. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Obstructive Sleep Disordered Breathing
- What is being tested?
- adenotonsillectomy
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Feb 2020
- Phase
- Observational
- 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 1 year to 3 years
- All sexes
- Child
Study population: The study will be conducted on Otorhinolaryngology Department, Assiut University Hospital.The study will be carried on 60 consecutive cases.
Who may be able to join
- • Age: 1-3 yeas.
- Diagnosed to have Obstructive Sleep-Disordered Breathing (OSDB) due to adenotonsillar enlargement confirmed by flexible nasoendoscopic assessment.
Who cannot join
- • Any associated medical comorbidity that contraindicates general anesthesia.
- Children having other causes for OSDB (e.g. obesity, Down syndrome, craniofacial abnormalities, neuromuscular disorders, sickle cell disease, or mucopolysaccharidoses).
- Refusal of enrollment in the research by care givers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adenoidectomy With Bilateral Partial Tonsillectomy Versus Adenoidectomy With Unilateral Complete Tonsillectomy in Treatment of Children With Obstructive Sleep-Disordered Breathing :Acomparative Study
The aim of the study is to evaluate adenoidectomy with bilateral partial tonsillectomy compared with adenoidectomy with classical unilateral complete tonsillectomy for management of pediatric Obstructive Sleep-Disordered Breathing (OSDB) in terms of efficacy of the technique and reducing postoperative complications.
Read the detailed description
Tonsillectomy is one of commonly performed pediatric otorhinolaryngology surgeries.
The two main indications of tonsillectomy in children include recurrent tonsillitis and Obstructive Sleep-Disordered Breathing (OSDB); including obstructive sleep apnea and upper airway resistance syndrome.
Total tonsillectomy means total removal of the tonsillar tissue with the tonsillar capsule. The main drawbacks of tonsillectomy are the potential for serious postoperative bleeding, postoperative pain, eating and drinking difficulties, and reduced immune function in the early stages after the operation. Partial tonsillectomy (intracapsular tonsillectomy, subtotal tonsillectomy) means subtotal removal of tonsillar tissue, leaving a margin of tissue on the tonsillar capsule . In contrast to complete tonsil removal, Partial tonsillectomy does not violate the capsule, and leaves lymphoid tissue as a protective tissue on the pharyngeal muscle layer thus preserving of the connective tissue capsule and pharyngeal muscles. This diminishes the direct and indirect trauma during an intraoperative procedure and the inflammation due to secondary infection during the postoperative period. Recently, children with OSDB have benefited from the less invasive partial tonsillectomy with less pain, equivalent or easier recovery, better food intake, and maintain the immunological function of the tonsils, while being as effective as tonsillectomy for resolving upper-airway obstructive symptoms.
Many studies have evaluated the outcomes of the two techniques, but uncertainty remains with regard to the efficacy, complications and long term outcomes. Some studies have reported the recurrence of obstructive symptoms due to regrowth of the remaining tonsillar tissue. Thus, it is important to evaluate Partial tonsillectomy comprehensively, especially paying attention to short-term and long-term results.
Over the last years, unilateral complete tonsillectomy (usually combined with adenoidectomy) was the most commonly utilized procedure for treatment of pediatric obstructive sleep-disordered breathing below the age of four years old in Otorhinolaryngology Department, Assiut University
- Conditions
- Obstructive Sleep Disordered Breathing
- Being tested
- adenotonsillectomy
- Keywords
- pediatric obstructive sleep disordered breathing-partial tonsillectomy -unilateral complete tonsillectomy -adenoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenotonsillectomyOther
adenoidectomy with bilateral tonsillectomy versus adenoidectomy with unilateral complete tonsillectomy
| Study group | Role | What they receive |
|---|---|---|
| adenoidectomy with bilateral partial tonsillectomy | Not described Receives: Other: adenotonsillectomy | |
| adenoidectomy with complete unilateral tonsillectomy | Not described Receives: Other: adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain assessed by cries scale
The CRIES scale is used for infants > than or = 38 weeks of gestation. Characteristics of crying, oxygen requirement, changes in vital signs, facial expression, and sleep state are scored. A maximal score of 10 is possible. If the CRIES score is > 4, further pain assessment should be undertaken, and analgesic administration is indicated for a score of 6 or higher.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Farag Zaki, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475329
- Sponsor's protocol ID
- AITOOSA
- Status last verified
- Jan 2019
- First submitted
- 12 Mar 2018
- Last updated
- 23 Jan 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoidectomy With Bilateral Partial Tonsillectomy Versus Adenoidectomy With Unilateral Complete Tonsillectomy in Treatment of Children With Obstructive Sleep-Disordered Breathing :Acomparative Study
- ClinicalTrials.gov ID
- NCT03475329
- Acronym / sponsor ID
- AITOOSA
- Conditions
- Obstructive Sleep Disordered Breathing
- Keywords
- pediatric obstructive sleep disordered breathing-partial tonsillectomy -unilateral complete tonsillectomy -adenoidectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 23 Mar 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.
The aim of the study is to evaluate adenoidectomy with bilateral partial tonsillectomy compared with adenoidectomy with classical unilateral complete tonsillectomy for management of pediatric Obstructive Sleep-Disordered Breathing (OSDB) in terms of efficacy of the technique and reducing postoperative complications.
Detailed description
Tonsillectomy is one of commonly performed pediatric otorhinolaryngology surgeries.
The two main indications of tonsillectomy in children include recurrent tonsillitis and Obstructive Sleep-Disordered Breathing (OSDB); including obstructive sleep apnea and upper airway resistance syndrome.
Total tonsillectomy means total removal of the tonsillar tissue with the tonsillar capsule. The main drawbacks of tonsillectomy are the potential for serious postoperative bleeding, postoperative pain, eating and drinking difficulties, and reduced immune function in the early stages after the operation. Partial tonsillectomy (intracapsular tonsillectomy, subtotal tonsillectomy) means subtotal removal of tonsillar tissue, leaving a margin of tissue on the tonsillar capsule . In contrast to complete tonsil removal, Partial tonsillectomy does not violate the capsule, and leaves lymphoid tissue as a protective tissue on the pharyngeal muscle layer thus preserving of the connective tissue capsule and pharyngeal muscles. This diminishes the direct and indirect trauma during an intraoperative procedure and the inflammation due to secondary infection during the postoperative period. Recently, children with OSDB have benefited from the less invasive partial tonsillectomy with less pain, equivalent or easier recovery, better food intake, and maintain the immunological function of the tonsils, while being as effective as tonsillectomy for resolving upper-airway obstructive symptoms.
Many studies have evaluated the outcomes of the two techniques, but uncertainty remains with regard to the efficacy, complications and long term outcomes. Some studies have reported the recurrence of obstructive symptoms due to regrowth of the remaining tonsillar tissue. Thus, it is important to evaluate Partial tonsillectomy comprehensively, especially paying attention to short-term and long-term results.
Over the last years, unilateral complete tonsillectomy (usually combined with adenoidectomy) was the most commonly utilized procedure for treatment of pediatric obstructive sleep-disordered breathing below the age of four years old in Otorhinolaryngology Department, Assiut University
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adenoidectomy with bilateral partial tonsillectomy | – | Other: adenotonsillectomy |
| adenoidectomy with complete unilateral tonsillectomy | – | Other: adenotonsillectomy |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- The study will be conducted on Otorhinolaryngology Department, Assiut University Hospital.The study will be carried on 60 consecutive cases.
Key inclusion criteria (2 listed)
- • Age: 1-3 yeas.
Key exclusion criteria (3 listed)
- • Any associated medical comorbidity that contraindicates general anesthesia.
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 |
|---|---|---|
| adenotonsillectomyadenoidectomy with bilateral tonsillectomy versus adenoidectomy with unilateral complete tonsillectomy | Other | adenoidectomy with bilateral partial tonsillectomy, adenoidectomy with complete unilateral tonsillectomy |
Primary outcome
postoperative pain assessed by cries scale
Time frame: two weeks
The CRIES scale is used for infants > than or = 38 weeks of gestation. Characteristics of crying, oxygen requirement, changes in vital signs, facial expression, and sleep state are scored. A maximal score of 10 is possible. If the CRIES score is > 4, further pain assessment should be undertaken, and analgesic administration is indicated for a score of 6 or higher.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Disordered Breathing, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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 23 Jan 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 Egypt. 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?
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?
postoperative pain assessed by cries scale (time frame: two weeks). 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 23 Jan 2019.