Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tonsillectomy +/- adenoidectomy | Active Comparator | Participants will undergo extracapsular tonsillectomy +/- adenoidectomy. |
|
| Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty | Experimental | Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lateral pharyngoplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | Change between baseline (immediately post-op) through 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change between baseline (immediately post-op) through 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants requiring intravenous fluid administration for dehydration | Presentation to healthcare facility due to lack of/perceived inadequate oral intake or decreased urination requiring intravenous fluid administration | Change between baseline (immediately post-op) through 6 weeks after surgery |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon Calaguas, MD | Contact | (909) 558-8558 | scalaguas@llu.edu | |
| Ethan Frank, MD | Contact | (909) 558-8558 | efrank@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tsungju O-Lee, MD | Loma Linda University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Professional Building - Murrieta | Not yet recruiting | Murrieta | California | 92563 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16414127 | Background | 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. | |
| 32057680 | Background | Kim 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
At the beginning of the study, each surgeon will receive an 80-item numbered list for which a random generator has been used to assign lateral pharyngoplasty or no lateral pharyngoplasty to each study participant. Each participant recruited for the study will undergo the correlating procedure at the time of surgery. Thus, the surgeon is necessarily not blinded, but the participant and parents would be blinded, and informed consent for the procedure would be for tonsillectomy +/- adenoidectomy, possible lateral pharyngoplasty.
| Tonsillectomy | Procedure | Extracapsular tonsillectomy |
|
| Loma Linda University ENT/Head & Neck Surgery | Recruiting | Riverside | California | 92506 | United States |
|
| Pediatric Ear, Nose, and Throat Surgery and Audiology | Not yet recruiting | San Bernardino | California | 92408 | United States |
|
| SAC Health - ENT Clinic | Not yet recruiting | San Bernardino | California | 92410 | United States |
|
| 9015944 | Background | Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91. |
| 30204981 | Background | Shu 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. |
| 30611028 | Background | Wulu 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. |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D014069 | Tonsillitis |
| C000729730 | tonsillolith |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided