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Completed

NCT Number: NCT00184392

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

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

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Key information

Conditions

Acute Recurrent Rhinosinusitis Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otolaryngology, Sorlandet Hospital, Kristiansand, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

debridement or saline irrigation

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. Pain due to cleaning of the nose

    Time frame: 1 and 2 weeks after surgery

    Pain on VAS

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

    Time frame: 2 weeks after surgery

    0=no crusts

    • =mild
    • =impossible to see under concha media

  3. the tendency to post operative infections

    Time frame: 3 months

    Patient information connected to examination from the investigator

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

    Time frame: 2 weeks

    0 no bleeding

    • spots of blood
    • bleeding from the nose

  5. 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Helse Midt-Norge
  • St. Olavs Hospital

Registry information

Official study title

Debridement After Functional Endoscopic Sinus Surgery

Important dates

Study start
2005
Primary completion
2005
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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