Hemostasis After AdenoidectomyNCT04130672
Hot Nasal Packing With Hot Saline Irrigation for Hemostasis After Adenoidectomy
A study testing Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy and Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy in people with Hemostasis After Adenoidectomy, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aimed to investigate the efficacy of hot posterior nasal packing and hot saline irrigation in bleeding control after adenoidectomy. Methods: 130 patients scheduled for the only adenoidectomy were included, and randomized into two groups at the beginning of the surgical operation. Read more about this study
- Who is it for?
- Ages 18 months to 13 years
- Conditions the study is for
- Hemostasis After Adenoidectomy
- What is being tested?
- Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy and Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2018to 15 Sep 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 months to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The patients who underwent adenoidectomy
Who cannot join
- Patients with chronic diseases
- Patients with bleeding diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hot Nasal Packing With Hot Saline Irrigation for Hemostasis After Adenoidectomy: A Prospective Randomized Controlled Study
Objective: This study aimed to investigate the efficacy of hot posterior nasal packing and hot saline irrigation in bleeding control after adenoidectomy.
Methods: 130 patients scheduled for the only adenoidectomy were included, and randomized into two groups at the beginning of the surgical operation. After adenoidectomy, saline impregnated tampon, and saline irrigation at room temperature (22 ° C) was applied to the patients in one group while 50 °C saline impregnated tampon and saline irrigation at the same temperature were applied to the patients in the other group. We record the time for up to 3 minutes after tamponage for bleeding control, bleeding volume, and the amount of bleeding in the nasopharynx
Read the detailed description
A prospective controlled randomized, single-blind study was designed to investigate the effect of a hot tampon with hot saline irrigation in hemostasis of adenoidectomy. After the parents signed informed consent, the patients under the age of 16 years, who underwent adenoidectomy due to the chronic nasal obstruction, were included in this study. Patients with chronic diseases, patients with bleeding diseases, and patients who had additional procedures were excluded from the study. Among 137 patients who met the inclusion criteria, one hundred and thirty patients agreed to give an informed consent form were included in the study. Under the Declaration of Helsinki, the study protocol was approved by the Clinical Research Ethics Committee (Permit number:5/2019 ).
The patients were divided into 22 ° C and 50 ° C irrigation groups using a computerized random number chart for each working day. To provide blind-evaluation of bleeding by the surgeon, a nurse organized heating the tampon and water, placed both nostrils latex Foley catheters and performed the irrigation processes.
The temperature of the irrigation water and the tampon was adjusted through mixing hot and cold water while immersing a thermometer in the water. The temperature of the irrigation fluid was also controlled every minute to make sure it is a constant value of 50 °C (Fig. 1).
All operations will be performed under general anesthesia and a flexible fiberoptic endoscope carefully assessed adenoid size before the operation with the following grading system: grade 1 (<1/3 of posterior choanae obstructed), grade 2 (1/3-2/3 of posterior choanae obstructed) and grade 3 (>2/3 of posterior choanae obstructed) [13]. Following the patients lay down with Rose's position which their head and neck were extended by placing rolls under the shoulder, the Boyle-Davis mouth retractor was placed, and adenoidectomy was performed via curettes. Complete excision was confirmed by digital palpation and nasopharyngeal mirror. After adenoidectomy, tonsil tampon at room temperature or 50 ° C was placed in the nasopharynx. Five minutes later, the tampon was removed, and 22 ° C or 50 ° C saline irrigation was applied. The scoring system described by Boezaart et al. [14] was adapted to the nasopharynx and using this scoring system and the direct visual observation instead of scoring endoscopy, the nasopharynx was scored and recorded at four different time points: after just tamponing, at the end of one, two and three minutes. The scoring was consisted of following scores: 0=there is no bleeding, 1=accumulation in the nasopharynx is very slow and slightly leak, 2= nasopharynx filling if not aspirated intermittently, 3= blood accumulation in the nasopharynx requiring frequent aspiration, 4= nasopharynx filling if not continuously aspirated, 5= severe bleeding overflowing to the oropharynx. The scoring process was terminated when the washing liquid was clean from bleeding during the irrigation. If this washing time was less than 3 minutes, bleeding scores at remaining time points were also accepted as 0. The irrigation fluids were applied at a rate of about 150 ccs per minute and not exceeding 500 ccs in total. When the irrigation time exceeded 3 minutes, the procedure was stopped to control the bleeding through bipolar cauterization, and the irrigation was continued with saline at the same temperature. The amount of bleeding was determined by removing the volume of irrigation fluid from the volume of the material accumulated in the aspirator chamber. The bleeding site and residual adenoid were detected by the nasopharyngeal mirror.
- Conditions
- Hemostasis After Adenoidectomy
- Being tested
- Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy, Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy
- Keywords
- Hot tampon, hot saline, adenoidectomy, hemostasis, bleeding control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomyProcedure or surgery
After hot packing nasopharyngeal irrigation with 50 C saline
Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomyProcedure or surgery
After cold packing nasopharyngeal irrigation with 22 C saline
| Study group | Role | What they receive |
|---|---|---|
| Hot saline irrigation | Other | . After adenoidectomy, tonsil tampon at room temperature or 50 ° C was placed in the nasopharynx. Five minutes later, the tampon was removed, and 50 ° C saline irrigation was applied. Receives: Procedure: Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy |
| Cold saline irrigation | Other | . After adenoidectomy, tonsil tampon at room temperature or 22 ° C was placed in the nasopharynx. Five minutes later, the tampon was removed, and 22 ° C saline irrigation was applied. Receives: Procedure: Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding time
Depanding on which type of saline irrigation and packing used after adenoidectomy
Measured: through bleeding control , an average of 5 minutes
Secondary outcomes (1)
Bleeding amount
Depanding on which type of saline irrigation and packing used after adenoidectomy
Measured: through bleeding control , an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start25 May 2018
- Primary completion25 Sep 2019
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemostasis After AdenoidectomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Alper Kanmaz, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130672
- Sponsor's protocol ID
- akanmaz
- Status last verified
- Oct 2019
- First submitted
- 19 Aug 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ıf anyone requires the patient's data
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hot Nasal Packing With Hot Saline Irrigation for Hemostasis After Adenoidectomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04130672
- Acronym / sponsor ID
- akanmaz
- Conditions
- Hemostasis After Adenoidectomy
- Keywords
- Hot tampon, hot saline, adenoidectomy, hemostasis, bleeding control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 17 Oct 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.
Objective: This study aimed to investigate the efficacy of hot posterior nasal packing and hot saline irrigation in bleeding control after adenoidectomy.
Methods: 130 patients scheduled for the only adenoidectomy were included, and randomized into two groups at the beginning of the surgical operation. After adenoidectomy, saline impregnated tampon, and saline irrigation at room temperature (22 ° C) was applied to the patients in one group while 50 °C saline impregnated tampon and saline irrigation at the same temperature were applied to the patients in the other group. We record the time for up to 3 minutes after tamponage for bleeding control, bleeding volume, and the amount of bleeding in the nasopharynx
Detailed description
A prospective controlled randomized, single-blind study was designed to investigate the effect of a hot tampon with hot saline irrigation in hemostasis of adenoidectomy. After the parents signed informed consent, the patients under the age of 16 years, who underwent adenoidectomy due to the chronic nasal obstruction, were included in this study. Patients with chronic diseases, patients with bleeding diseases, and patients who had additional procedures were excluded from the study. Among 137 patients who met the inclusion criteria, one hundred and thirty patients agreed to give an informed consent form were included in the study. Under the Declaration of Helsinki, the study protocol was approved by the Clinical Research Ethics Committee (Permit number:5/2019 ).
The patients were divided into 22 ° C and 50 ° C irrigation groups using a computerized random number chart for each working day. To provide blind-evaluation of bleeding by the surgeon, a nurse organized heating the tampon and water, placed both nostrils latex Foley catheters and performed the irrigation processes.
The temperature of the irrigation water and the tampon was adjusted through mixing hot and cold water while immersing a thermometer in the water. The temperature of the irrigation fluid was also controlled every minute to make sure it is a constant value of 50 °C (Fig. 1).
All operations will be performed under general anesthesia and a flexible fiberoptic endoscope carefully assessed adenoid size before the operation with the following grading system: grade 1 (<1/3 of posterior choanae obstructed), grade 2 (1/3-2/3 of posterior choanae obstructed) and grade 3 (>2/3 of posterior choanae obstructed) [13]. Following the patients lay down with Rose's position which their head and neck were extended by placing rolls under the shoulder, the Boyle-Davis mouth retractor was placed, and adenoidectomy was performed via curettes. Complete excision was confirmed by digital palpation and nasopharyngeal mirror. After adenoidectomy, tonsil tampon at room temperature or 50 ° C was placed in the nasopharynx. Five minutes later, the tampon was removed, and 22 ° C or 50 ° C saline irrigation was applied. The scoring system described by Boezaart et al. [14] was adapted to the nasopharynx and using this scoring system and the direct visual observation instead of scoring endoscopy, the nasopharynx was scored and recorded at four different time points: after just tamponing, at the end of one, two and three minutes. The scoring was consisted of following scores: 0=there is no bleeding, 1=accumulation in the nasopharynx is very slow and slightly leak, 2= nasopharynx filling if not aspirated intermittently, 3= blood accumulation in the nasopharynx requiring frequent aspiration, 4= nasopharynx filling if not continuously aspirated, 5= severe bleeding overflowing to the oropharynx. The scoring process was terminated when the washing liquid was clean from bleeding during the irrigation. If this washing time was less than 3 minutes, bleeding scores at remaining time points were also accepted as 0. The irrigation fluids were applied at a rate of about 150 ccs per minute and not exceeding 500 ccs in total. When the irrigation time exceeded 3 minutes, the procedure was stopped to control the bleeding through bipolar cauterization, and the irrigation was continued with saline at the same temperature. The amount of bleeding was determined by removing the volume of irrigation fluid from the volume of the material accumulated in the aspirator chamber. The bleeding site and residual adenoid were detected by the nasopharyngeal mirror.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A Prospective Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Hot saline irrigation | Other | Procedure: Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy. After adenoidectomy, tonsil tampon at room temperature or 50 ° C was placed in the nasopharynx. Five minutes later, the tampon was removed, and 50 ° C saline irrigation was applied. |
| Cold saline irrigation | Other | Procedure: Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy. After adenoidectomy, tonsil tampon at room temperature or 22 ° C was placed in the nasopharynx. Five minutes later, the tampon was removed, and 22 ° C saline irrigation was applied. |
Who may qualify
- Ages
- 18 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The patients who underwent adenoidectomy
Key exclusion criteria (2 listed)
- Patients with chronic diseases
- Patients with bleeding diseases
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 |
|---|---|---|
| Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomyAfter hot packing nasopharyngeal irrigation with 50 C saline | Procedure or surgery | Hot saline irrigation |
| Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomyAfter cold packing nasopharyngeal irrigation with 22 C saline | Procedure or surgery | Cold saline irrigation |
Primary outcome
Bleeding time
Time frame: through bleeding control , an average of 5 minutes
Depanding on which type of saline irrigation and packing used after adenoidectomy
1 secondary outcome
Bleeding amount
Time frame: through bleeding control , an average of 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: Undecided. ıf anyone requires the patient's data
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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 Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy and Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy in people with Hemostasis After Adenoidectomy, run by Sanko University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 17 Oct 2019. 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 Turkey (Türkiye). 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. 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?
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?
Bleeding time (time frame: through bleeding control , an average of 5 minutes). 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 17 Oct 2019.