Post - Tonsillectomy PainNCT04161196
Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
A study testing tonsil pillars suturing and tonsillectomy without tonsil pillars suturing in people with Post - Tonsillectomy Pain, run by Hillel Yaffe Medical Center.
Trial summary
comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post - Tonsillectomy Pain
- What is being tested?
- tonsil pillars suturing and tonsillectomy without tonsil pillars suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and over.
- patients with tonsillectomy indication due to chronic Tonsillitis.
Who cannot join
- patients with tonsillectomy indication without chronic tonsillitis ( due to other causes).
- chronic disease, chronic neurology disease.
- chronic psychology disease.
- bleeding tendency.
Trial locations and contacts
No sites are listed yet.
About this study
comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy.
- Conditions
- Post - Tonsillectomy Pain
- Being tested
- tonsil pillars suturing, tonsillectomy without tonsil pillars suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonsil pillars suturingProcedure or surgery
The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.
tonsillectomy without tonsil pillars suturingProcedure or surgery
tonsillectomy without The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.
| Study group | Role | What they receive |
|---|---|---|
| patients with post - tonsillectomy suturing tonsil pillars | Active comparator | Not described Receives: Procedure: tonsil pillars suturing |
| patients without post - tonsillectomy suturing tonsil pillars | Placebo comparator | Not described Receives: Procedure: tonsillectomy without tonsil pillars suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
two patients' group in this study , one group will have a Tonsil pillars suturing after the tonsillectomy and the second group will not have this technique after the tonsillectomy, then patience should answer a post pain tonsillectomy questionnaire , by the questionnaire and the checkups to compare how each group affected ( using SPSS program and Statistics Methods.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post - Tonsillectomy PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161196
- Sponsor's protocol ID
- 077-19-HYMC
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
- ClinicalTrials.gov ID
- NCT04161196
- Acronym / sponsor ID
- 077-19-HYMC
- Conditions
- Post - Tonsillectomy Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 Nov 2019 (actual)
- 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.
comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with post - tonsillectomy suturing tonsil pillars | Active comparator | Procedure: tonsil pillars suturing |
| patients without post - tonsillectomy suturing tonsil pillars | Placebo comparator | Procedure: tonsillectomy without tonsil pillars suturing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 and over.
- patients with tonsillectomy indication due to chronic Tonsillitis.
Key exclusion criteria (4 listed)
- patients with tonsillectomy indication without chronic tonsillitis ( due to other causes).
- chronic disease, chronic neurology disease.
- chronic psychology disease.
- bleeding tendency.
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 |
|---|---|---|
| tonsil pillars suturingThe technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely. | Procedure or surgery | patients with post - tonsillectomy suturing tonsil pillars |
| tonsillectomy without tonsil pillars suturingtonsillectomy without The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely. | Procedure or surgery | patients without post - tonsillectomy suturing tonsil pillars |
Primary outcome
Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
Time frame: 1 year
two patients' group in this study , one group will have a Tonsil pillars suturing after the tonsillectomy and the second group will not have this technique after the tonsillectomy, then patience should answer a post pain tonsillectomy questionnaire , by the questionnaire and the checkups to compare how each group affected ( using SPSS program and Statistics Methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing tonsil pillars suturing and tonsillectomy without tonsil pillars suturing in people with Post - Tonsillectomy Pain, run by Hillel Yaffe Medical Center.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronen Bar, MD (+972-52-9257123, ronen.n.bar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing. (time frame: 1 year). 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 14 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.