The primary objective is to assess whether a 10-14 day Merocel with TC packing of the sinus is better than a one day Merocel with TC packing in the improvement of clinical and sinus parameters in patients with symmetrical CRSwNP following FESS. The…
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Source
Brief title
Condition
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ethmoid inflammation
Mean difference in ethmoid inflammation and polyp score (graded in a visual
analog scale 0 to 100 mm) between two sides on day 30 (± 7 days).
Secondary outcome
Mean difference in ethmoid inflammation (graded in a visual analog scale 0 to
100 mm) between two sides. This will be assessed during two follow up visits:
day 90 (± 14 days) and day 180 (± 14 days).
Polyp score
Mean difference in the polyp score between two sides. It will be assessed three
times during follow up: day 30 (± 7 days), day 90 (± 14 days) and day 180 (± 14
days).
Presence of synechiae:
Mean difference in synechiae presence (graded in a visual analog scale 0 to 100
mm) between two sides. The presence of synechiae will be assessed on three
different follow up visits: day 30 (± 7 days), day 90 (± 14 days) and 180 (± 14
days).
Middle turbinate position:
Mean difference in middle turbinate position (lateralized, medialized or
neutral) between two sides will be assessed on three different follow up
visits: on day 30 (± 7 days), 90 (± 14 days) and day 180 (± 14 days).
Modified Lund-Kennedy score:
Mean difference in the modified Lund-Kennedy score between two sides. The
modified Lund Kennedy score will be assessed three times during follow up: day
30 (± 7 days), day 90 (± 14 days) and day 180 (± 14 days).
Patient discomfort
Mean difference of overall patient`s discomfort score determined by severity of
nasal symptoms (graded 0-5) between two sides. Patients will be given a diary,
and asked to assess their discomfort daily.
Three ENT surgeons will independently assess the ethmoid inflammation, presence
of synechiae, position of middle turbinate and the modified Lund-Kennedy score
system through blinded video-review.
Background summary
Chronic rhinosinusitis is a very prevalent condition which affects
approximately 14% of the Dutch general population [1]. Distinction is made
between, chronic rhinosinusitis without nasal polyps and chronic rhinosinusitis
with nasal polyps (CRSwNP). CRSwNP in adults is defined as presence of two or
more symptoms, one of which should be either nasal obstruction / blockage /
congestion or nasal discharge / postnasal drip, and can be accompanied with
facial pain, pressure and reduction or loss of smell lasting for at least 12
weeks. Nasal polyps must be visualized bilaterally on the endoscopical
examination in the middle meatus [2]. Treatment of CRSwNP should be tailored to
each patient, and may be conservative or surgical. Conservative treatment
options include topical steroids, nasal irrigation with saline solution, and
oral antibiotics. If conservative management fails to improve symptoms,
surgical treatment should be considered [2]. However, the optimal surgical
treatment for CRSwNP has yet to be identified.
Functional endoscopic sinus surgery (FESS) is considered a safe and effective
treatment (EPOS) and is commonly performed in the Academic Medical Center
(AMC). The underlying principle of FESS is the restoration of the anatomy and
function of the respiratory epithelium of the paranasal sinuses in minimally
invasive fashion [3][4]. Even after a successful surgery, surgical treatment
may fail due to a variety of reasons which can occur postoperatively, including
mucosal inflammation, lateralization of the middle turbinate, formation of
synechiae, recurrence of nasal polyps and ostial stenosis of the operated sinus
[5][6][7][2]. To prevent the occurrence of these changes and optimize treatment
outcome, several postoperative management strategies have been developed. These
postoperative management strategies often include the local administration of
corticosteroids in the sinus cavity to reduce mucosal inflammation and
stabilization of the medialized turbinate.
Up to date, there is no consensus on the optimal postoperative management of
FESS in patients with CRSwNP. Consequently, there are several techniques in
use, such as; the placement of nonabsorbable nasal packing with or without
local corticosteroid [8][9][10][11], drug eluting absorbable stents [12][9],
microde-brider medialization technique [13], and middle turbinate suture
technique [14]. Moreover, there are also authors who prefer no placement of the
nasal packing [15][9].
Study objective
The primary objective is to assess whether a 10-14 day Merocel with TC packing
of the sinus is better than a one day Merocel with TC packing in the
improvement of clinical and sinus parameters in patients with symmetrical
CRSwNP following FESS. The 0 hypothesis is that there is no difference in
inflammation between one day packing or 10-14 days packing of the sinus with
Merocel with TC. The secondary objective of this trial is to evaluate the level
of improvement in nasal symptoms, for which the patient*s subjective discomfort
level will be scored.
Study design
This randomized, single center, controlled clinical trial shall be conducted at
the Academic Medical Center (AMC), Department of Otorhinolaryngology. The
sample size will consist of 20 patients having FESS due to CRSwNP refractory to
medical treatment. This study is designed to evaluate whether a 10-14 day
Merocel with TC packing of the sinus is better than a one day Merocel with TC
packing. Patients will be used as their own controls, with packing duration
randomized per side (ethmoid).
Intervention
At the time of the procedure, the packing will be prepared for use according to
its *Directions for Use*. Patients will be prepared in the normal manner for
endonasal surgery. Intravenous CS shall be administered during anesthetic
induction. Antibiotic therapy shall consist of cefazoline 1000mg, during the
anesthetic induction and amoxicillin/clavulanate 625mg per os every 8 hours for
14 days after surgery. Patients with penicillin allergy shall receive
levofloxacin 500 mg once daily or clindamycin 300mg three times daily instead.
At the end of the procedure and in absence of complication, the operating
surgeon shall receive two Merocel packings with TC which will be inserted to
the nasal cavity as per "Directions for Use". To prevent introduction of
confounding factors, no other hemostatic materials shall be allowed in any of
the ethmoid cavities. Packing of the inferior meatus shall be allowed only if
necessary and as long as it remains inferior to the middle meatus. If excessive
bleeding requires further hemostatic material the patient shall be excluded.
Surgical manipulation of the middle turbinate for medialization or partial
resection will be allowed. Complete surgical removal of middle turbinate will
not be allowed. All procedures shall be recorded onto physical media and
reviewed to ensure uniform compliance with all study specifications. Topical CS
will be started one day after packing removal.
At the end of the procedure, the randomization process will assign a number for
each packed side separately.
Directions for Use
* Inspect the package for any obvious damage, discard if damaged.
* Open the package through the tear-notch.
* Open the foil packaging.
* Inspect the Merocel packing. If the Merocel packing is broken or
damaged discard and obtain a new Merocel packing.
* Open the package using sterile technique.
* Using a carefully dried *pick up* or forceps hold Merocel packing by one
extremity.
* Smear the TC ointment over the surface of the Merocel packing.
* Remove excessive TC ointment.
* Ensure hemostasis in operated sinus cavities prior to insertion.
* Gently introduce the Merocel with TC packing into the nasal cavity.
* Under endoscopy apply it into the surgically treated ethmoid sinus.
* Make sure all parts of the device are well apposed against the tissue.
* Confirm final placement by endoscopic visualization.
Study burden and risks
Terracortril and Merocel are registered products.
The use of nasal packing with Merocel and Terracortril may carry the following
risks:
Mild risks: discomfort and irritation.
Moderate risks: headache, hypersensitivity, bronchospasm, pack dislodgement,
foreign body granuloma and bleeding after removal.
Severe: status asthmaticus, angioedema, anaphylactic shock, blood dyscrasias,
convulsion, aspiration and toxic shock syndrome
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
patients aged ><=18 years, symmetrical crswnp, in whom bilateral primary or revision endoscopic ethmoidectomy is performed due to failure of medical treatment. Intervention on other paranasal sinuses (with the exception of extensive frontal sinus intervention (Draf 3) and correction of septal deviation as part of the study procedure shall be allowed when necessary
Exclusion criteria
Patients dependent on oral CS and patients who took oral CS from 30 days before the surgery. Patients with cystic fibrosis, antrochoanal polyp, inverted papilloma and vasculitis. Patients with known hypersensitivity to any component of Terracortril will be excluded from the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59079.018.16 |