The effect of duration of nonabsorbable nasal packing (merocel) soaked with oxytetracycline and hydrocortisone (terrracortril) in the post-operative management of functional endoscopic sinus surgery in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on healing of the sinus cavity

The effect of duration of nonabsorbable nasal packing (merocel) soaked with oxytetracycline and hydrocortisone (terrracortril) in the post-operative management of functional endoscopic sinus surgery in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on healing of the sinus cavity - The effect of nasal packing in the post-operative management of FESS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42966

Enrollment

Registered

2016-11-08

Start date

2016-11-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasal polyps sinus inflammation

Interventions

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 b

chronic rhinosinusitis

endoscopic sinus surgery

postoperative management

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: patients aged >

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)