Postoperative Nasal Irrigation Using Mucolytic Agents

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

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.

Study Overview

• Status: Unknown
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Drug: saline nasal irrigation alone; Drug: dissolved N-Acetylcystine

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Avraham Abergel, MD, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (ESTIMATE): April 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: endoscopy; QOL; sinus surgery; mucolysis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: TASMC-12-AA-0089-CTIL