Postoperative Nasal Irrigation Using Mucolytic Agents

NCT01582555 | Unknown

• 1 other identifier: TASMC-12-AA-0089-CTIL
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedure, Unspecified

Keywords

mucolysis; QOL; endoscopy; sinus surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lund-Kennedy endoscopic score (LKES)

  1y

Study Arms (2)

saline irrigation

EXPERIMENTAL

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

intervention arm (group B),

EXPERIMENTAL

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

Interventions

saline nasal irrigation alone DRUG

control arm (group A) of generic saline irrigation alone, irrigating with 20 mL per nostril tid for a total of 120 mL daily irrigation

Also known as: Ocean, Saline Nasal Mist, Deep Sea Nasal Spray

saline irrigation

dissolved N-Acetylcystine DRUG

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).

Also known as: Ocean, Saline Nasal Mist, Deep Sea Nasal Spray

intervention arm (group B),

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over
• Patient undergoing endoscopic sinus surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Study Officials

• Avraham Abergel, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AVRAHAM ABRGEL, MD

CONTACT

97236973544

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 20, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

IL (1)