A Study of Different Endoscopic Surgery Procedures in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Surgery Clinical Trial

Official title:

Long-term Outcomes of Radical Endoscopic Sinus Surgery Plus Draf 3 Procedure in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps and Asthma: A 9-year Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878355
• Other study ID #: TR-ES
• Status: Completed
• Phase: N/A
• Start date: January 1, 2010
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CRS remains a common challenging clinical entity due to variable phenotypes with different underlying mechanisms that lead to persistence or recurrence polyps. The eosinophils dominant inflammation was considered as a major pathological hallmark and challenges of CRS with nasal polyps (CRSwNP). Differentiate surgical approaches towards eosinophilic CRSwNP (eCRSwNP) should be addressed on the basis of the inflammatory endotypes. eCRSwNP has been recognized as the most easily relapsed type of CRS, and the combination of asthma increases the difficulty of treatment. Till now there is no recognized surgical strategy for eCRSwNP with asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 71 Years

Eligibility

Inclusion Criteria:

• The diagnosis of CRSwNP was based on the standard criteria issued in the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines.

• Participants had at least 1 previous sinus surgery underwent FESS (middle turbinate (MT) preserved), good gasification of frontal sinus and with concomitant asthma.

• The diagnosis of asthma was confirmed by a chest physician according to Global Initiative for Asthma (GINA) guidelines.

• Polyp biopsy was undertaken 1 week before surgery and the eCRSwNP was confirmed by the number of eosinophils exceeded 10% of total infiltrating inflammatory cells in the polyp tissue through the evaluation by using hematoxylin and eosin (H&E) staining.

Exclusion Criteria:

• Patients were excluded if they had unilateral disease, allergic fungal rhinosinusitis, antrochoanal polyps, or cysts.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Nasal Polyps
• Sinusitis
• Surgery

Intervention

Procedure:
• radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.
The procedure of RESS was completed as described in "full-house FESS (FHF)" approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected. The technique for the Draf 3 frontal drillout procedure was described in detail in previous publications with resection of the superior nasal septum, central frontal sinus floor, and frontal beak region, resulting in a widely patent, oval-shaped, common frontal sinus neo-ostium
• radical endoscopic sinus surgery (RESS)
The procedure of RESS was completed as described in "full-house FESS (FHF)" approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected
• functional endoscopic sinus surgery (FESS)
FESS was performed by Messerklinger technique with middle turbinate preservation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month	1 year after surgery
Primary	recurrence	Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month	3 years after surgery
Primary	recurrence	Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month	5 years after surgery
Secondary	Visual analogue scale of 4 major clinical symptoms	Subjective symptoms were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable. Four major symptoms include nasal congestion, rhinorrhea, loss of smell, and headache and/or facial pain.	at baseline, and 1 year, 3years, 5 years after surgery
Secondary	Sinus-specific quality of life (QoL)	Sinus-specific quality of life (QoL) was assessed using the 22-item Sinonasal Outcome Test (SNOT-22)	at baseline, and 1 year, 3years, 5 years after surgery
Secondary	Postoperatively endoscopic results	Postoperatively endoscopic results were scored according to the Lund-Kennedy system, with the assessment of edema, nasal discharge, scarring, and crusting	at baseline, and 1 year, 3years, 5 years after surgery