Clinical trial NCT04130672: Hot Nasal Packing With Hot Saline Irrigation for Hemostasis After Adenoidectomy
Official title: Hot Nasal Packing With Hot Saline Irrigation for Hemostasis After Adenoidectomy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemostasis After Adenoidectomy
Keywords: Hot tampon
hot saline
adenoidectomy
hemostasis
bleeding control
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective Randomized Controlled Study
Primary purpose: OTHER

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

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.

Eligibility criteria: Inclusion Criteria:

The patients who underwent adenoidectomy

Exclusion Criteria:

* Patients with chronic diseases
* Patients with bleeding diseases

Primary outcomes:
measure: Bleeding time
timeFrame: through bleeding control , an average of 5 minutes
Secondary outcomes:
measure: Bleeding amount
timeFrame: through bleeding control , an average of 5 minutes
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Mahmut Alper Kanmaz
Study officials:
References: