NCT00184392

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

11 months

First QC Date

September 15, 2005

Last Update Submit

February 27, 2014

Conditions

Acute Recurrent Rhinosinusitis

Keywords

Sinus surgeryendoscopicpostoperative caredebridementrandomizedacute recurrent rhinosinusitischronic rhinosinusitisnasal polypsChronic rhinosinusitis with nasal polypsChronic rhinosinusitis without nasal polyps

Outcome Measures

Primary Outcomes (1)

  • Adhesions in middle meatus or not

    synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present

    3 months

Secondary Outcomes (5)

  • Pain due to cleaning of the nose

    1 and 2 weeks after surgery

  • Does cleaning of the nose reduce: crusts in the nose 14 days after surgery

    2 weeks after surgery

  • the tendency to post operative infections

    3 months

  • Does debridement increase bleeding from the nose the first 14 days after surgery

    2 weeks

  • nasal congestion after surgery

    2 weeks

Study Arms (1)

debridement or saline irrigation

EXPERIMENTAL

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

Interventions

debridement or saline irrigationPROCEDURE

debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery

debridement or saline irrigation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Otolaryngology, Sorlandet Hospital

Kristiansand, 4606, Norway

Location

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, 7052, Norway

Location

Related Publications (1)

  • 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.

    PMID: 17075402RESULT

MeSH Terms

Conditions

Nasal Polyps

Interventions

Debridement

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2005

Study Completion

September 1, 2007

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

NO(2)