Comparative Efficacy of Buffered Hypertonic Saline and Ringer’s Lactate Nasal Irrigation in Postoperative Management of Chronic Rhinosinusitis: A Randomized Double-Blind Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Primary Outcome:
研究概览
简要总结
The primary aim of this study is to evaluate and compare the efficacy, safety, and patient compliance of
Ringer’s lactate and buffered hypertonic saline nasal irrigation in the postoperative management of
chronic rhinosinusitis (CRS) following endoscopic sinus surgery (ESS). The study seeks to determine
whether Ringer’s lactate nasal irrigation provides comparable or superior symptom relief, promotes
better mucosal healing (as assessed by Lund Kennedy score), and minimizes side effects, offering a
safer and more tolerable alternative for long-term use compared to buffered hypertonic saline.
The study is designed to test the following hypotheses:
H1 (Primary Hypothesis):
Patients using Ringer’s lactate nasal irrigation will experience greater improvements (reduction in
symptom burden) in Sino-Nasal Outcome Test-22 (SNOT-22) scores compared to those using buffered
hypertonic saline solutions over the 6-week treatment period relative to baseline assessments in postsurgical CRS patients.
H2 (Secondary Hypothesis):
Ringer’s lactate nasal irrigation will result in greater reductions in Lund-Kennedy scores (improvement
in mucosal healing, reduced inflammation, and polyp recurrence) compared to buffered hypertonic
saline solutions over the 6-week treatment period relative to baseline assessments in post-surgical CRS
patients.
Purpose of Hypothesis Testing
By evaluating these hypotheses, this study aims to provide high-quality evidence on the efficacy,
tolerability, and compliance of Ringer’s lactate nasal irrigation as a potential alternative to buffered
hypertonic saline in post-surgical CRS management. The results will contribute to a comparative
analysis of symptom relief, mucosal recovery, and patient adherence.
Findings from this trial may inform clinical guidelines by determining whether Ringer’s lactate offers
superior or equivalent benefits to hypertonic saline in enhancing post-ESS outcomes, potentially
optimizing long-term CRS management strategies and improving patient quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •Inclusion Criteria:
- •Age And Gender: Adults aged between eighteen to sixty-five years, regardless of gender.
- •Diagnosis Of Chronic Rhinosinusitis (CRS): Diagnosed with Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS Two Thousand Twenty) criteria, characterized by the following: Symptom Duration: Presence of symptoms for a minimum of twelve weeks.
- •Symptoms: Presence of two or more of the following symptoms, one of which must be either nasal blockage, nasal obstruction, nasal congestion, or nasal discharge (either anterior or posterior nasal drip): Mucopurulent drainage (anterior or posterior) Nasal obstruction or congestion Facial pain, pressure, or fullness Decreased or loss of sense of smell Objective Confirmation: Symptomatology must be confirmed by either: Endoscopic Signs: Presence of nasal polyps, mucopurulent discharge from the middle meatus, or mucosal edema or obstruction in the middle meatus.
- •CT Imaging: Evidence of mucosal alterations in the osteomeatal complex and or sinuses.
- •Inflammatory Documentation: Evidence of sinonasal inflammation must be documented by one or more of the following: Purulent (non-clear) mucus or edema in the middle meatus or ethmoid region Presence of nasal polyps in the nasal cavity or middle meatus Radiographic imaging showing inflammation in the paranasal sinuses
- •Willingness To Participate: Patients must be willing to provide informed consent and agree to adhere to all study protocols.
排除标准
- •Exclusion Criteria:
- •Pregnancy And Lactation: Pregnant or breastfeeding women.
- •Severe Comorbid Conditions: Presence of severe uncontrolled comorbidities such as: Uncontrolled diabetes Autoimmune diseases Severe cardiovascular or respiratory diseases
- •Known Allergies: Allergies to components of the nasal irrigation solutions, including Ringers lactate or buffered hypertonic saline.
- •Language Barrier: Patients unable to speak or understand Hindi or English.
- •Mucociliary Disorders: History of primary ciliary dyskinesia, cystic fibrosis, or other significant mucociliary dysfunction.
- •Dependence On Corticosteroids: Patients requiring prolonged systemic corticosteroid therapy for comorbid conditions like asthma or chronic obstructive pulmonary disease.
- •Infections And Other Nasal Conditions: History of cerebrospinal fluid leak Current infection or history of: Tuberculosis lung infection Herpes infection of the eye
- •Surgical History And Disorders: Previous nasal or sinus surgery within the last three months unrelated to the current chronic rhinosinusitis condition.
- •SNOT Twenty Two Score: Patients with baseline SNOT Twenty Two scores below nine, as they may not achieve a minimally clinically significant improvement in the study.
- •Bleeding Disorders Or Allergy To Anesthetics: Known bleeding disorders, use of blood thinners, or allergies to topical or injectable lidocaine.
- •Other Exclusions: Patients unwilling or unable to comply with study protocols or follow-up visits.
结局指标
主要结局
Primary Outcome:
时间窗: Baseline to the end of the treatment period, which is six weeks
Change in Sino Nasal Outcome Test Twenty Two (SNOT Twenty Two) Scores: The primary outcome is the change in SNOT Twenty Two scores from baseline to the end of the treatment period, which is six weeks. SNOT Twenty Two is a validated patient reported outcome measure assessing the severity of sinonasal symptoms and their impact on quality of life. Scores range from zero to one hundred ten, with higher scores indicating worse symptoms. Changes in SNOT Twenty Two will be compared between the Buffered Hypertonic Saline and Ringer’s Lactate groups.
时间窗: Baseline to the end of the treatment period, which is six weeks
次要结局
- Lund Kennedy’s Score via Nasal Endoscopy Findings(Patient comfort levels will be assessed using a Likert scale (1-10))
研究者
PATTEM MAHEETH
Indira Gandhi medical College and hospital