Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health
排除标准
- •Subjects with congenital syndromes and/or developmental delay
- •Subjects with cancer
- •Subjects with gastrostomy tube use or dependence
- •Subjects undergoing intracapsular tonsillectomy
研究组 & 干预措施
Tonsillectomy +/- adenoidectomy
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.
干预措施: Tonsillectomy (Procedure)
Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.
干预措施: Lateral pharyngoplasty (Procedure)
Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.
干预措施: Tonsillectomy (Procedure)
结局指标
主要结局
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
时间窗: 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
Level of post-operative pain
时间窗: 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 not requiring surgical intervention
时间窗: 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
次要结局
- Post-operative duration (in days) to normal oral intake(Change between baseline (immediately post-op) through 6 weeks after surgery)