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

Primary Purpose

Acute Recurrent Rhinosinusitis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
debridement or saline irrigation
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Recurrent Rhinosinusitis focused on measuring Sinus surgery, endoscopic, postoperative care, debridement, randomized, acute recurrent rhinosinusitis, chronic rhinosinusitis, nasal polyps, Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis without nasal polyps

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Otolaryngology, Sorlandet Hospital
  • Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

debridement or saline irrigation

Arm Description

1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation

Outcomes

Primary Outcome Measures

Adhesions in middle meatus or not
synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present

Secondary Outcome Measures

Pain due to cleaning of the nose
Pain on VAS
Does cleaning of the nose reduce: crusts in the nose 14 days after surgery
0=no crusts =mild =impossible to see under concha media
the tendency to post operative infections
Patient information connected to examination from the investigator
Does debridement increase bleeding from the nose the first 14 days after surgery
0 no bleeding spots of blood bleeding from the nose
nasal congestion after surgery
a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery

Full Information

First Posted
September 15, 2005
Last Updated
February 27, 2014
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Midt-Norge
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1. Study Identification

Unique Protocol Identification Number
NCT00184392
Brief Title
Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?
Official Title
Debridement After Functional Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Midt-Norge

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Recurrent Rhinosinusitis
Keywords
Sinus surgery, endoscopic, postoperative care, debridement, randomized, acute recurrent rhinosinusitis, chronic rhinosinusitis, nasal polyps, Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis without nasal polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
debridement or saline irrigation
Arm Type
Experimental
Arm Description
1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation
Intervention Type
Procedure
Intervention Name(s)
debridement or saline irrigation
Intervention Description
debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery
Primary Outcome Measure Information:
Title
Adhesions in middle meatus or not
Description
synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain due to cleaning of the nose
Description
Pain on VAS
Time Frame
1 and 2 weeks after surgery
Title
Does cleaning of the nose reduce: crusts in the nose 14 days after surgery
Description
0=no crusts =mild =impossible to see under concha media
Time Frame
2 weeks after surgery
Title
the tendency to post operative infections
Description
Patient information connected to examination from the investigator
Time Frame
3 months
Title
Does debridement increase bleeding from the nose the first 14 days after surgery
Description
0 no bleeding spots of blood bleeding from the nose
Time Frame
2 weeks
Title
nasal congestion after surgery
Description
a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Bugten, M.D.
Organizational Affiliation
Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Sorlandet Hospital
City
Kristiansand
ZIP/Postal Code
4606
Country
Norway
Facility Name
Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
City
Trondheim
ZIP/Postal Code
7052
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17075402
Citation
Bugten V, Nordgard S, Steinsvag S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. doi: 10.1097/01.mlg.0000241362.06072.83.
Results Reference
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Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?

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