Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 763
- 试验地点
- 1
- 主要终点
- which side was more painful on or about postoperative day 14
研究概览
简要总结
The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy leads to less pain and bleeding risk than leaving it open to heal by secondary intention.
详细描述
After induction of appropriate general anesthesia, a tonsillectomy was performed and control of bleeding was achieved as is routine for the individual Otolaryngologist performing the procedure. Next the surgeon used 3-0 chromic (absorbable) sutures on tapered needles to close one tonsillar fossa but leave the tonsillar fossa on the other side open. The side chosen was determined by a computer generated schedule. Routine postoperative care was given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
did not tell participant which side was sutured.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient for whom tonsillectomy is recommended for recurrent pharyngitis, obstructive sleep disorder, snoring, halitosis, feeding difficulty associated with adenotonsillar hypertrophy, and who in the investigator's opinion, is capable of providing reliable responses to post-operative follow-up questions as defined in this protocol.
排除标准
- •Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess
研究组 & 干预措施
suture one tonsillar fossa
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
干预措施: suture one tonsillar fossa (Procedure)
One side not sutured
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
结局指标
主要结局
which side was more painful on or about postoperative day 14
时间窗: 14 days
determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver
次要结局
- Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event(40 days)
- any other adverse events (complications)(40 days)
- which side was more painful on or about postoperative day 21(21 days)
- overall assessment at the postoperative clinic visit (on or about day 28)(28 days)
研究者
Bruce Matt
Associate Professor
Indiana University School of Medicine