A Prospective Double-blined Randomized Trial to Evaluate The Influence of Tantum Verde® on Recovery Following Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bleeding: time to complete cessation, need for re-operation
研究概览
简要总结
The purpose of this study is to assess the effects of Tantum Verde® for improving recovery following tonsillectomy Study design: A prospective double-blined randomized trial. Sample size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be treated with a placebo.
The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign the inform consent in one of two places: in the departments before the surgery or in the clinic in the visit before the surgery. The patients will be evaluated for their ability to gargle and spit water before the surgery, after which they will be assigned to either the treatment group who will get a solution of Tantum Verde or the control group who will receive saline with mint flavor, both in identicle bottles. Randomization will be done using a random number generator program.
The patients will be asked to gargle and spit the solution they received three times a day for 30 seconds, for the following week after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing tonsillectomy with or without adenoidectomy
- •Over 12 years of age
- •Signed informed consent by patient or caregiver
排除标准
- •Inability to gargle and spit
- •Allergy to one of the solution ingredients
- •Significant comorbidity (e.g. diabetes, bleeding disorders)
- •Unable/ unwilling to comply with the protocol requirements
- •Pregnancy or breast feeding
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- •Withdrawal Criteria:
- •Patients did not comply with the protocol requirements
研究组 & 干预措施
Tantum Verde® mouthwash
solution of Tantum Verde
干预措施: Tantum Verde® mouthwash (Drug)
placebo mouthwash
saline with mint flavor
干预措施: Placebo mouthwash (Other)
结局指标
主要结局
Bleeding: time to complete cessation, need for re-operation
时间窗: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
Pain: reduction in severity based on VAS score.
时间窗: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain: time to complete resolution based on VAS score.
时间窗: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively
时间窗: Data of Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively will be collected on day 14
Bleeding: postoperative measures to reduce bleeding
时间窗: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
次要结局
- Duration of hospital stay(day14)
- Time to return to normal diet and activities.(day 14)
- Readmission for any reason.(14 Days after surgery)
研究者
Ronen Ohad
MD
Western Galilee Hospital-Nahariya