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Hot Nasal Packing With Hot Saline Irrigation for Hemostasis After Adenoidectomy

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ClinicalTrials.gov Identifier: NCT04130672
Recruitment Status : Active, not recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmut Alper Kanmaz, Sanko University

Brief 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. 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


Condition or disease Intervention/treatment Phase
Hemostasis After Adenoidectomy Procedure: Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy Procedure: Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Prospective Randomized Controlled Study
Masking: Single (Investigator)
Masking Description: Single blinded study
Primary Purpose: Other
Official Title: Hot Nasal Packing With Hot Saline Irrigation for Hemostasis After Adenoidectomy: A Prospective Randomized Controlled Study
Actual Study Start Date : May 25, 2018
Actual Primary Completion Date : September 25, 2019
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arm Intervention/treatment
Hot saline irrigation
. 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.
Procedure: Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy
After hot packing nasopharyngeal irrigation with 50 C saline

Cold saline irrigation
. 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.
Procedure: Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy
After cold packing nasopharyngeal irrigation with 22 C saline




Primary Outcome Measures :
  1. Bleeding time [ Time Frame: through bleeding control , an average of 5 minutes ]
    Depanding on which type of saline irrigation and packing used after adenoidectomy


Secondary Outcome Measures :
  1. Bleeding amount [ Time Frame: through bleeding control , an average of 5 minutes ]
    Depanding on which type of saline irrigation and packing used after adenoidectomy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The patients who underwent adenoidectomy

Exclusion Criteria:

  • Patients with chronic diseases
  • Patients with bleeding diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130672


Locations
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Turkey
Mahmut Alper Kanmaz
Gaziantep, Turkey, 27090
Sponsors and Collaborators
Sanko University

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Responsible Party: Mahmut Alper Kanmaz, Assistant Professor, Sanko University
ClinicalTrials.gov Identifier: NCT04130672     History of Changes
Other Study ID Numbers: akanmaz
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: ıf anyone requires the patient's data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmut Alper Kanmaz, Sanko University:
Hot tampon
hot saline
adenoidectomy
hemostasis
bleeding control
Additional relevant MeSH terms:
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Hemostatics
Coagulants