Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04130672 |
| Other study ID # |
akanmaz |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2018 |
| Est. completion date |
September 15, 2020 |
Study information
| Verified date |
October 2019 |
| Source |
Sanko University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
