Postoperative Nasal Irrigation Using Mucolytic Agents
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Purpose
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 | Intervention |
|---|---|
|
Surgical Procedure, Unspecified |
Drug: saline nasal irrigation alone Drug: dissolved N-Acetylcystine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Postoperative Nasal Irrigation Using Mucolytic Agents in Patients Undergoing Endoscopic Sinus Surgery |
- change in QOL based on the Sino-Nasal Outcome Test-22 (SNOT-22) scores [ Time Frame: 1 y ] [ Designated as safety issue: No ]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.
- Lund-Kennedy endoscopic score (LKES) [ Time Frame: 1y ] [ Designated as safety issue: No ]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)
| Estimated Enrollment: | 44 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Ocean, Saline Nasal Mist, Deep Sea Nasal Spray
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: AVRAHAM ABRGEL, MD | 97236973544 |
| Israel | |
| Tel Aviv Medical Center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: AVRAHAN ABERGEL, MD 97236973544 | |
| Principal Investigator: | Avraham Abergel, MD | Tel Aviv Medical Center |
More Information
No publications provided
| Responsible Party: | Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01582555 History of Changes |
| Other Study ID Numbers: | TASMC-12-AA-0089-CTIL |
| Study First Received: | April 16, 2012 |
| Last Updated: | April 19, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
mucolysis QOL endoscopy sinus surgery |
Additional relevant MeSH terms:
|
Acetylcysteine Expectorants N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 16, 2013