Postoperative Nasal Irrigation Using Mucolytic Agents

Surgical Procedure, Unspecified Clinical Trial

Official title:

Postoperative Nasal Irrigation Using Mucolytic Agents in Patients Undergoing Endoscopic Sinus Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01582555
• Other study ID #: TASMC-12-AA-0089-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: April 16, 2012
• Last updated: April 19, 2012
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: AVRAHAM ABRGEL, MD
• Phone: 97236973544
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Nasal irrigation techniques have been used for many years and been shown to improve symptoms of rhinosinusitis. Although there is a wealth of literature available, establishing treatment protocols can be difficult because of the great variability in recommended composition (seawater or hypertonic or isotonic saline with or without additives) and irrigation technique (variations in pressure and volume). Nasal irrigation is also used in many centers as part of postoperative treatment protocols and in particular has been recommended following endoscopic sinus surgery (ESS). Nasal crusting and thick nasal discharge have a negative impact on these patients quality of life (QOL). At the time of our study, there are no studies comparing irrigation with mucolysis with saline irrigation following ESS. The investigators aimed to assess whether mucolysis is effective at improving patients QOL and reducing postoperative signs as assessed endoscopically.

Description:

The study will take place at Tel Aviv Sourasky medical center, otolaryngology outpatient clinic, a tertiary care academic hospital, for two years. It will be double-arm, open label, randomized controlled trial comparing two different methods of medical therapy following ESS. The allocation ratio is intended to be approximately equal for each arm. The two arms consisted of: a control arm (group A) of generic saline irrigation alone, irrigating with 20 mL per nostril tid for a total of 120 mL daily irrigation; and intervention arm (group B), which included generic N-Acetylcystine of 200 mg dissolved in 200 mL saline irrigated as per group A, 20 mL per nostril given tid daily (for a total of 120 mg). All medications will be used daily for the 3 months duration of the post-operative follow up. Patients will be instructed as to correct irrigation technique prior to discharge home from the hospital, and will be reminded of this technique at each postoperative clinic visit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 or over

2. Patient undergoing endoscopic sinus surgery

Exclusion Criteria:

1. Allergy to N-Acetylcysteine,

2. Any other nasal surgery performed concomitantly

3. Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) nasal pathology

4. Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome

5. Unable to give informed consent due to mental impairment

6. Unable to adhere follow up or treatment.

7. Patients requiring any additional nasal sprays (e.g. steroid sprays)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Drug:
• saline nasal irrigation alone
control arm (group A) of generic saline irrigation alone, irrigating with 20 mL per nostril tid for a total of 120 mL daily irrigation
• dissolved N-Acetylcystine
intervention arm (group B), which included generic N-Acetylcystine of 200 mg dissolved in 200 mL saline irrigated as per group A, 20 mL per nostril given tid daily (for a total of 120 mg).

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in QOL based on the Sino-Nasal Outcome Test-22 (SNOT-22) scores	The primary outcome measure is change in QOL based on the Sino-Nasal Outcome Test-22 (SNOT-22) scores.(5) SNOT-22 scores were chosen as the primary outcome due to the importance of studying patient QOL outcomes as opposed to imaging or endoscopy scores that often do not correlate with patients' subjective perceptions of disease severity.	1 y	No
Secondary	Lund-Kennedy endoscopic score (LKES)	Secondary outcomes are the Lund-Kennedy endoscopic score (LKES) of each side of the nose that will be graded between 0 and 2 as recommended by the International Congress on Sinus Disease (Adhesions, Polyps, Crusting: 0 = none, 1 = middle meatus only, 2 = beyond middle meatus; Discharge: 0 = none, 1 = clear, thin, 2 = thick, purulent; Edema: 0 = none, 1 = mild, 2 = severe)	1y	No