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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184392
First Posted: September 16, 2005
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
The goal of this study is to increase knowledge about how to treat patients after sinus surgery.

Condition Intervention
Acute Recurrent Rhinosinusitis Procedure: debridement or saline irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Debridement After Functional Endoscopic Sinus Surgery

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Adhesions in middle meatus or not [ Time Frame: 3 months ]

    synechia between concha media and lateral nasal wall 0=no adhesion

    1=adhesions present



Secondary Outcome Measures:
  • Pain due to cleaning of the nose [ Time Frame: 1 and 2 weeks after surgery ]
    Pain on VAS

  • Does cleaning of the nose reduce: crusts in the nose 14 days after surgery [ Time Frame: 2 weeks after surgery ]

    0=no crusts

    1. =mild
    2. =impossible to see under concha media

  • the tendency to post operative infections [ Time Frame: 3 months ]
    Patient information connected to examination from the investigator

  • Does debridement increase bleeding from the nose the first 14 days after surgery [ Time Frame: 2 weeks ]

    0 no bleeding

    1. spots of blood
    2. bleeding from the nose

  • nasal congestion after surgery [ Time Frame: 2 weeks ]
    a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery


Enrollment: 60
Study Start Date: January 2005
Study Completion Date: September 2007
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: debridement or saline irrigation
1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation
Procedure: debridement or saline irrigation
debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184392


Locations
Norway
Department of Otolaryngology, Sorlandet Hospital
Kristiansand, Norway, 4606
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, Norway, 7052
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Helse Midt-Norge
Investigators
Principal Investigator: Vegard Bugten, M.D. Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184392     History of Changes
Other Study ID Numbers: 229-04
First Submitted: September 15, 2005
First Posted: September 16, 2005
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Norwegian University of Science and Technology:
Sinus surgery
endoscopic
postoperative care
debridement
randomized
acute recurrent rhinosinusitis
chronic rhinosinusitis
nasal polyps
Chronic rhinosinusitis with nasal polyps
Chronic rhinosinusitis without nasal polyps