Sleep-Disordered BreathingNCT05575401
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
A study testing Lateral pharyngoplasty and Tonsillectomy in people with Sleep-Disordered Breathing and Sleep Apnea Syndromes in Children, run by Loma Linda University at 4 sites in United States.
Trial summary
The goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are: Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children, Sleep Apnea, Obstructive
- What is being tested?
- Lateral pharyngoplasty and Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 May 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health
Who cannot join
- Subjects with congenital syndromes and/or developmental delay
- Subjects with cancer
- Subjects with gastrostomy tube use or dependence
- Subjects undergoing intracapsular tonsillectomy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Loma Linda University Professional Building - Murrieta
Murrieta, California, 92563
Tsungju O-Lee, MD, 951-290-4000, tolee@llu.edu
Vikrum Thimmappa, MD
- Recruiting
Loma Linda University ENT/Head & Neck Surgery
Riverside, California, 92506
Tsungju O-Lee, MD, 909-558-2824, tolee@llu.edu
Vikrum Thimmappa, MD, (909) 558-2824, vathimmappa@llu.edu
- Not yet recruiting
Pediatric Ear, Nose, and Throat Surgery and Audiology
San Bernardino, California, 92408
Tsungju O-Lee, MD, 909-558-2824, tolee@llu.edu
Vikrum Thimmappa, MD, (909) 558-2824, vathimmappa@llu.edu
- Not yet recruiting
SAC Health - ENT Clinic
San Bernardino, California, 92410
Vikrum Thimmappa, MD, 909-382-7100, vathimmappa@llu.edu
Vikrum Thimmappa, MD
About this study
Official title: Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
The goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are:
- Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone?
- Do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone?
- Is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? Researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. Parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.
Read the detailed description
This is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. Participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. The investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone.
- Conditions
- Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children, Sleep Apnea, Obstructive, Tonsillitis, Tonsillar Hypertrophy, Tonsil Stone
- Being tested
- Lateral pharyngoplasty, Tonsillectomy
- Keywords
- Tonsillectomy, Post-tonsillectomy hemorrhage, Post-tonsillectomy complication, Lateral pharyngoplasty
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Tonsillitis, tonsillolith
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral pharyngoplastyProcedure or surgery
Two figure-of-8 sutures using 3-0 vicryl are used to approximate the anterior and posterior tonsillar pillars and reconstruct the continuous mucosal covering of the lateral pharyngeal walls.
TonsillectomyProcedure or surgery
Extracapsular tonsillectomy
| Study group | Role | What they receive |
|---|---|---|
| Tonsillectomy +/- adenoidectomy | Active comparator | Participants will undergo extracapsular tonsillectomy +/- adenoidectomy. Receives: Procedure: Tonsillectomy |
| Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty | Experimental | Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty. Receives: Procedure: Lateral pharyngoplasty; Procedure: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of post-operative pain
Will use the Wong-Baker FACES pain scale, which shows a series of faces ranging from a happy face at 0 (representing no pain) to a crying face at 10 (representing the worst pain imaginable). Parent/caregiver will document the pain score and pain medication administrations/duration of use.
Measured: Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room
Measured: Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention
Count of subject/caregiver reports or presentations to a healthcare facility due to a post-tonsillectomy hemorrhage event that does not require control of hemorrhage in the operating room
Measured: Change between baseline (immediately post-op) through 6 weeks after surgery
Secondary outcomes (1)
Post-operative duration (in days) to normal oral intake
Parent/caregiver's will estimate the participant's daily soft diet oral intake as a percentage of perceived baseline/normal
Measured: Change between baseline (immediately post-op) through 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start17 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants ages 3-17 years undergoing tonsillectomy for any reason will be randomized to either undergo tonsillectomy +/- adenoidectomy (standard of care practice) or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention). Parents of participants in both arms will be given post-operative worksheets to document pain scores, pain medication administration, estimates of daily per os intake, and any complications.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsungju O-Lee, MD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575401
- Sponsor's protocol ID
- 5210282
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2022
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genc E, Hanci D, Ergin NT, Dal T. Can mucosal sealing reduce tonsillectomy pain? Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):725-30. doi: 10.1016/j.ijporl.2005.12.005. Epub 2006 Jan 18.
PubMed 16414127Kim JS, Kim BG, Kim DH, Hwang SH. Efficacy of pillar suture for post-tonsillectomy morbidity in children: a meta-analysis. Braz J Otorhinolaryngol. 2021 Sep-Oct;87(5):583-590. doi: 10.1016/j.bjorl.2019.12.007. Epub 2020 Jan 25.
PubMed 32057680Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91.
PubMed 9015944Shu Y, Yao HB, Yang DZ, Wang B. Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. Arch Argent Pediatr. 2018 Oct 1;116(5):316-321. doi: 10.5546/aap.2018.eng.316. English, Spanish.
PubMed 30204981Wulu JA, Chua M, Levi JR. Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review. Int J Pediatr Otorhinolaryngol. 2019 Feb;117:204-209. doi: 10.1016/j.ijporl.2018.12.003. Epub 2018 Dec 4.
PubMed 30611028
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05575401
- Acronym / sponsor ID
- 5210282
- Conditions
- Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children, Sleep Apnea, Obstructive, Tonsillitis, Tonsillar Hypertrophy, Tonsil Stone
- Keywords
- Tonsillectomy, Post-tonsillectomy hemorrhage, Post-tonsillectomy complication, Lateral pharyngoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2022 (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 goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are:
- Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone?
- Do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone?
- Is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? Researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. Parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.
Detailed description
This is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. Participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. The investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants ages 3-17 years undergoing tonsillectomy for any reason will be randomized to either undergo tonsillectomy +/- adenoidectomy (standard of care practice) or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention). Parents of participants in both arms will be given post-operative worksheets to document pain scores, pain medication administration, estimates of daily per os intake, and any complications.
| Arm | Type | Receives |
|---|---|---|
| Tonsillectomy +/- adenoidectomy | Active comparator | Procedure: TonsillectomyParticipants will undergo extracapsular tonsillectomy +/- adenoidectomy. |
| Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty | Experimental | Procedure: Lateral pharyngoplasty, Procedure: TonsillectomyParticipants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health
Key exclusion criteria (4 listed)
- Subjects with congenital syndromes and/or developmental delay
- Subjects with cancer
- Subjects with gastrostomy tube use or dependence
- Subjects undergoing intracapsular tonsillectomy
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 |
|---|---|---|
| Lateral pharyngoplastyTwo figure-of-8 sutures using 3-0 vicryl are used to approximate the anterior and posterior tonsillar pillars and reconstruct the continuous mucosal covering of the lateral pharyngeal walls. | Procedure or surgery | Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty |
| TonsillectomyExtracapsular tonsillectomy | Procedure or surgery | Tonsillectomy +/- adenoidectomy, Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty |
Primary outcome
Level of post-operative pain
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Will use the Wong-Baker FACES pain scale, which shows a series of faces ranging from a happy face at 0 (representing no pain) to a crying face at 10 (representing the worst pain imaginable). Parent/caregiver will document the pain score and pain medication administrations/duration of use.
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Count of subject/caregiver reports or presentations to a healthcare facility due to a post-tonsillectomy hemorrhage event that does not require control of hemorrhage in the operating room
1 secondary outcome
Post-operative duration (in days) to normal oral intake
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 16414127Genc E, Hanci D, Ergin NT, Dal T. Can mucosal sealing reduce tonsillectomy pain? Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):725-30. doi: 10.1016/j.ijporl.2005.12.005. Epub 2006 Jan 18.
- Background: PubMed 32057680Kim JS, Kim BG, Kim DH, Hwang SH. Efficacy of pillar suture for post-tonsillectomy morbidity in children: a meta-analysis. Braz J Otorhinolaryngol. 2021 Sep-Oct;87(5):583-590. doi: 10.1016/j.bjorl.2019.12.007. Epub 2020 Jan 25.
- Background: PubMed 9015944Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91.
- Background: PubMed 30204981Shu Y, Yao HB, Yang DZ, Wang B. Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. Arch Argent Pediatr. 2018 Oct 1;116(5):316-321. doi: 10.5546/aap.2018.eng.316. English, Spanish.
- Background: PubMed 30611028Wulu JA, Chua M, Levi JR. Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review. Int J Pediatr Otorhinolaryngol. 2019 Feb;117:204-209. doi: 10.1016/j.ijporl.2018.12.003. Epub 2018 Dec 4.
- Individual participant dataSharing planned: No
Related trials for Sleep-Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
Active, not recruitingObservational study
Epidemiology of Sleep-Disordered Breathing in Adults
Sleep Disorders, Cerebrovascular Disorders
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.
Tsungju O-Lee, MD principal investigator
Loma Linda University Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral pharyngoplasty and Tonsillectomy in people with Sleep-Disordered Breathing and Sleep Apnea Syndromes in Children, run by Loma Linda University at 4 sites 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 4 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Calaguas, MD ((909) 558-8558, scalaguas@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of post-operative pain (time frame: Change between baseline (immediately post-op) through 6 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575401, which also lists 5 linked publications.
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 Feb 2026.