The Influence of Tantum Verde® on Recovery Following Tonsillectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Double-blined Randomized Trial to Evaluate The Influence of Tantum Verde® on Recovery Following Tonsillectomy

Conditions
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Tonsillectomy, Adenoidectomy

Intervention / Treatment
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* Drug: Tantum Verde® mouthwash
* Other: Placebo mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing tonsillectomy with or without adenoidectomy Over 12 years of age Signed informed consent by patient or caregiver Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tantum Verde® mouthwash<br>solution of Tantum Verde | Drug: Tantum Verde® mouthwash<br> <br> |
| Placebo Comparator: placebo mouthwash<br>saline with mint flavor | Other: Placebo mouthwash<br>* Mouthwash with placebo solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain: reduction in severity based on VAS score. |  | postoperative pain using VAS(Visual Analogue Scale) on day 14 | 
| Pain: time to complete resolution based on VAS score. |  | postoperative pain using VAS(Visual Analogue Scale) on day 14 | 
| Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively |  | Data of Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively will be collected on day 14 | 
| Bleeding: time to complete cessation, need for re-operation |  | bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery. | 
| Bleeding: postoperative measures to reduce bleeding |  | bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission for any reason. |  | 14 Days after surgery | 
| Duration of hospital stay |  | day14 | 
| Time to return to normal diet and activities. |  | day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients undergoing tonsillectomy with or without adenoidectomy