TonsillectomyNCT02190162
The Influence of Tantum Verde® on Recovery Following Tonsillectomy
A study testing Tantum Verde® mouthwash in people with Tonsillectomy and Adenoidectomy, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Tonsillectomy, Adenoidectomy
- What is being tested?
- Tantum Verde® mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing tonsillectomy with or without adenoidectomy
- Over 12 years of age
- Signed informed consent by patient or caregiver
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Double-blined Randomized Trial to Evaluate The Influence of Tantum Verde® on Recovery Following Tonsillectomy
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.
- Conditions
- Tonsillectomy, Adenoidectomy
- Being tested
- Tantum Verde® mouthwash, Placebo mouthwash
- Keywords
- Patients undergoing tonsillectomy with or without adenoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tantum Verde® mouthwashDrug
Placebo mouthwashOther
Mouthwash with placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Tantum Verde® mouthwash | Active comparator | solution of Tantum Verde Receives: Drug: Tantum Verde® mouthwash |
| placebo mouthwash | Placebo comparator | saline with mint flavor Receives: Other: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: reduction in severity based on VAS score.
Measured: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain: time to complete resolution based on VAS score.
Measured: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively
Measured: 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
Measured: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
Bleeding: postoperative measures to reduce bleeding
Measured: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
Secondary outcomes (3)
Readmission for any reason.
Measured: 14 Days after surgery
Duration of hospital stay
Measured: day14
Time to return to normal diet and activities.
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ronen Ohad, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190162
- Sponsor's protocol ID
- 0028-14-NHR
- Status last verified
- Oct 2018
- First submitted
- 16 Jun 2014
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double-blined Randomized Trial to Evaluate The Influence of Tantum Verde® on Recovery Following Tonsillectomy
- ClinicalTrials.gov ID
- NCT02190162
- Acronym / sponsor ID
- 0028-14-NHR
- Conditions
- Tonsillectomy, Adenoidectomy
- Keywords
- Patients undergoing tonsillectomy with or without adenoidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Jul 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tantum Verde® mouthwash | Active comparator | Drug: Tantum Verde® mouthwashsolution of Tantum Verde |
| placebo mouthwash | Placebo comparator | Other: Placebo mouthwashsaline with mint flavor |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing tonsillectomy with or without adenoidectomy
- Over 12 years of age
- Signed informed consent by patient or caregiver
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tantum Verde® mouthwash | Drug | Tantum Verde® mouthwash |
| Placebo mouthwashMouthwash with placebo solution | Other | placebo mouthwash |
Primary outcome
Pain: reduction in severity based on VAS score.
Time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain: time to complete resolution based on VAS score.
Time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively
Time frame: 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
Time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
Bleeding: postoperative measures to reduce bleeding
Time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
3 secondary outcomes
Readmission for any reason.
Time frame: 14 Days after surgery
Duration of hospital stay
Time frame: day14
Time to return to normal diet and activities.
Time frame: day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tantum Verde® mouthwash in people with Tonsillectomy and Adenoidectomy, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: reduction in severity based on VAS score. (time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.