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Table 1 Summary of the included studies

From: Efficacy and safety of paranasal sinus balloon catheter dilation in pediatric chronic rhinosinusitis: a systematic review

Study Design nd Mean Age (Age range), years Sinuses dilated via balloon Inclusion Adjunct procedure(s) Follow-up time Efficacy (by SN-5)
Mean (SD)
Efficacy (by others)
Mean (SD)
Revision, antibiotics use and AEs
Ramadan HH et al. 2010a [35] Prospective interventional non-randomized 30 (55 sinuses) 6.6 (2–11) 48 Maxillary 2 Frontal 5 Sphenoid Chronic sinusitis (> 3 months or 6 episodes per year) AND 2 failed courses of antibiotics AND positive CT scan Adenoidectomy (= 17) 52 weeks Preop: 4.2, Postop: 3;
24 (80%) improveda
NR Second intervention by ESS (2);
AEs: NR
Ramadan HH et al. 2010b [36] Prospective single arm cohort 24 (56 sinuses) 6.5 (2–11) 50 Maxillary 2 Frontal 4 Sphenoid Refractory CRS which failed medical treatment AND evidence of CRS on CT scan Adenoidectomy (= 15); Ethmoidectomy (= 6) 52 weeks Preop: 4.9 (1.14), Postop: 2.95 (1.35);
21 improveda
NR AEs: None
Ramadan HH et al. 2012 [28] Prospective single arm cohort 26 (33 sinuses) 7.7 (4–12) 33 Maxillary Chronic sinusitis (> 3 months or 6 episodes per year) after failed adenoidectomy AND positive CT findings. Ethmoidectomy (n = 4); Maxillary antrostomy (n = 3); Revision adenoidectomy (= 2) 52 weeks Preop: 4.6 (0.9), Postop: 3 (1.2);
21 (81%) improveda
NR AEs: None
Thottam PJ et al. 2012 [30] Retrospective, two group cohort blinded 15 (40 sinuses) 9.3 (3–17) 30 Maxillary 10 Frontal Refractory CRS (at least 90 days despite medical therapy) AND CT confirmed uncomplicated CRS with the presence of maxillary +/− frontal sinus disease. Ethmoidectomy > 4 months (average of 37 weeks) SN-5: NR;
12 (80.0%) Improvedb
NR Second intervention by ESS (1);
Off Antibiotic: 11 (73.3%);
AEs: None
Wang F et al. 2015 [29] Prospective interventional non-randomized controlled 42 9.3 (7–12) Maxillary and Frontalc Diagnosis of CRS according to EPOS 2012. Refractory CRS (defined as at least 2 years despite medical therapy) Adenoidectomy 1 year Preop: 4.3 (0.9), Postop: 2.9 (0.8);
39 (92.9%) improveda
VAS
Preop: 5.2 (1.4),
Postop: 3.1 (1.6)
AEs: periorbital swelling (1)
Thottam PJ et al. 2016 [31] Retrospective, two group cohort 13 (34 sinuses) 9.3 (3–18) 26 Maxillary 8 Frontal Refractory sinus symptoms despite medical treatments AND CT scan confirmed uncomplicated CRS and the presence of maxillary sinus disease with a Lund-Mackay score greater than 5. Ethmoidectomy 2 years SN-5: NR;
10 (76.9%) Improvedb
NR Second intervention by ESS (1);
AEs: NR
Soler ZM et al. 2017 [24] Prospective single arm cohort 33 6.6 (2–12) Maxillary, Frontal and Sphenoidc Diagnosis of CRS according to EPOS12, positive CT findings and disease resistant to medical treatments. Adenoidectomy (= 19); Inferior turbinate reduction (n = 6); Ethmoidectomy (n = 4); Tonsillectomy (= 5); Others (= 4) 6 months Preop: 4.8 (1.2), Postop: 1.7 (0.8);
32 (97%) improveda
NR Second intervention (0);
AEs: None
Liu J et al. 2017 [25] Prospective single arm cohort 30 (61 sinuses) 10.2 (6–15) 38 Maxillary 9 Frontal 14 Sphenoid Confirmed by positive Nasal endoscopy and CT scan AND failed Medical management for at least 3 months None 12 months Preop: 23.04 (12.47), Postop: 1.07 (2.11) Lund-Mackay score Preop: 12.29 (6.23), Postop: 1.39 (2.47);
VAS Preop: 17.86 (7.59),
Postop: 0.57 (1.60);
Endoscopic score of Lund-kennedy preop: 6.69 (3.07),
postop: 0.36 (1.89)
AEs: synechia (3)
Gerber ME et al. 2018 [32] Randomized controlled blinded study 12 7 Maxillaryc CRS with at least 12 weeks of two symptoms AND refractory to medical treatments AND recurrence (4 or more episodes per year) AND evidence of rhinosinusitis on CT scan. Adenoidectomy with maxillary sinus irrigation (all patients) 12–18 months Preop: 3.62 (1.24), Postop: 2.40 (1.11) NR NR
Zalzal HG et al. 2019 [33] Retrospective single arm cohort 38 6.76 Maxillaryc CRS with at least 90 days of 2 or more of symptoms, or endoscopic signs AND failure of medical treatment defined by EPOS 2012 AND previous adenoidectomy AND Lund-Mackay score of at least 5 AND maxillary sinus involvement. None 5 years SN-5: NR NR Second intervention by ESS: 5 (13.1%);
Off antibiotic: 26 (68.4%)
  1. AEs Adverse events
  2. CRS Chronic rhinosinusitis
  3. CT Computed tomography
  4. ESS Endoscopic sinus surgery
  5. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012
  6. NR Not reported
  7. SN-5 Sino-Nasal 5 quality of life scale
  8. VAS Visual analogue scale
  9. a(0.5 decrease or more in SN-5 score) described by Kay and Rosenfeld
  10. bImprovement were defined as a decrease in the total complaint score of 1 or more symptoms. Symptoms are facial pain, sinus congestion, postnasal drip, rhinorrhea, headache, and low-grade fever
  11. cNumber of sinuses dilated via balloon sinuplasty was not specified in the included sample
  12. dNumber of children underwent balloon sinuplasty and included in the analysis of the respective study