Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?

Acute Recurrent Rhinosinusitis Clinical Trial

Official title:

Debridement After Functional Endoscopic Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184392
• Other study ID #: 229-04
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: February 27, 2014
• Start date: January 2005
• Est. completion date: September 2007

Study information

• Verified date: February 2014
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to increase knowledge about how to treat patients after sinus surgery.

Description:

Many surgeons consider the postoperative treatment after sinus surgery as important for the outcome as the surgery itself. However, postoperative treatment regimes differ considerably between surgeons. They include non-intervention, frequent in-office endoscopic debridement, stenting of the middle meatus, saline douching or irrigation of the nose, or combinations of these measures in various ways. The lack of consensus is unfortunate. It indicates a lack of knowledge about how to treat these patients optimally after surgery. This is partly due to a lack of internationally acknowledged randomised, comparative, prospective studies on the effects of the various postoperative measures and their interactions. Accordingly, some patients may receive a too intensive postoperative follow up, with unnecessary frequent visits with the doctor, unnecessary bleeding and inconvenience from unnecessary debridement/cleaning of the nose, and increased costs due to unnecessary medication. Conversely, there may be patients that receive too little attention in the postoperative period, and thus may have a suboptimal result of the operation.

Frequent cleaning/debridement of the nose after sinus surgery is believed to improve the outcome of functional endoscopic sinus surgery (FESS). However, the scientific data on its effects are limited. The purpose of this study was to evaluate the effects of cleaning/ debridement of the middle meatus 5-7 days and 12-14 days after sinus surgery in a randomized, partly blinded, controlled clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria are acute recurrent rhinosinusitis and chronic rhinosinusitis. The investigators used the classification of rhinosinusitis proposed by Lanza and Kennedy.

Exclusion Criteria:

• Previous FESS

• Systemic disease with affection of the nose (Wegener's granulomatosis, cystic fibrosis, Kartagener's syndrome, sarcoid)

• Primary ciliary dyskinesia

• Pregnancy

• Septoplasty in the same surgery

• Ongoing treatment for cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Recurrent Rhinosinusitis

Intervention

Procedure:
• debridement or saline irrigation
debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery

Locations

Country	Name	City	State
Norway	Department of Otolaryngology, Sorlandet Hospital	Kristiansand
Norway	Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Helse Midt-Norge, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Bugten V, Nordgård S, Steinsvåg S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesions in middle meatus or not	synechia between concha media and lateral nasal wall 0=no adhesion; 1=adhesions present	3 months	No
Secondary	Pain due to cleaning of the nose	Pain on VAS	1 and 2 weeks after surgery	No
Secondary	Does cleaning of the nose reduce: crusts in the nose 14 days after surgery	0=no crusts; =mild; =impossible to see under concha media	2 weeks after surgery	No
Secondary	the tendency to post operative infections	Patient information connected to examination from the investigator	3 months	No
Secondary	Does debridement increase bleeding from the nose the first 14 days after surgery	0 no bleeding; spots of blood; bleeding from the nose	2 weeks	No
Secondary	nasal congestion after surgery	a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery	2 weeks	No