Postoperative Nasal Irrigation Using Mucolytic Agents

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01582555

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Procedure, Unspecified	Drug: saline nasal irrigation alone Drug: dissolved N-Acetylcystine	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: saline irrigation 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;	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 Other Names: Ocean, Saline Nasal Mist, Deep Sea Nasal Spray
Experimental: intervention arm (group B), 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).	Drug: 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). Other Names: Ocean, Saline Nasal Mist, Deep Sea Nasal Spray

Arm

Intervention/Treatment

Experimental: saline irrigation

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;

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

Other Names:

Ocean, Saline Nasal Mist, Deep Sea Nasal Spray

Experimental: intervention arm (group B),

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).

Drug: 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).

Other Names:

Ocean, Saline Nasal Mist, Deep Sea Nasal Spray

Outcome Measures

Primary Outcome Measures

change in QOL based on the Sino-Nasal Outcome Test-22 (SNOT-22) scores [1 y]
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.

Secondary Outcome Measures

Lund-Kennedy endoscopic score (LKES) [1y]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18 or over
Patient undergoing endoscopic sinus surgery

Exclusion Criteria:

Allergy to N-Acetylcysteine,
Any other nasal surgery performed concomitantly
Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) nasal pathology
Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
Unable to give informed consent due to mental impairment
Unable to adhere follow up or treatment.
Patients requiring any additional nasal sprays (e.g. steroid sprays)