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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Turkey (Türkiye)1 site
  • Mahmut Alper Kanmaz

    Gaziantep, 27090

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04130672
Study groupRoleWhat they receive
Hot saline irrigationOther. 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 irrigationOther. 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.

  1. 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)
  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.

  1. First posted17 Oct 2019
  2. Study start25 May 2018
  3. Primary completion25 Sep 2019
  4. Study completion15 Sep 2020 (estimated)

Resources

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)
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

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.

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