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Nasal PolypsPhase 3NCT00440219

The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.

A Phase 3 study testing Oral Prednisone in people with Nasal Polyps, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to determine if a short course of oral prednisone helps to improve the operative field and ease of surgery by minimizing bleeding during nasal polypectomy surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasal Polyps
What is being tested?
Oral Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
2 sitesCanada
Study dates
Nov 2010to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients with severe obstructing nasal polyps scheduled for surgery.

Who cannot join

  • Patient unable to tolerate side effects of prednisone
  • Uncontrolled diabetes mellitus
  • Hypertension
  • Previous congestive heart failure
  • Acute/chronic systemic infection
  • History of hypersensitivity to prednisone
  • History of cataracts or glaucoma

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Mount Sinai Hospital, University of Toronto

    Toronto, Ontario, M5G 1X5

  • St. Joseph's Health Centre

    Toronto, Ontario, M6R 1B5

Other trials in Canada

About this study

This study aims to determine if a short course of oral prednisone helps to improve the operative field and ease of surgery by minimizing bleeding during nasal polypectomy surgery.

Read the detailed description

This study will be conducted as a double blinded randomized control trial and aims to recruit about 34 patients (17 patients per arm). Patients will be randomized to receive either prednisone 50 mg po x10 days or an identical looking placebo x10 days. Photographs of the polyps will be taken prior to the intervention, on the day of surgery and in the follow-up visit. Symptom survey (SNOT22) will also be administered at these same time points. Blood loss will be determined volumetrically from the suction canister and by using the Wormald Surgical field grading scale. Surgeons will also complete a survey postoperatively evaluating visibility, difficulty and ease of surgery. At 2 weeks, 1 month, 3 months and 6 months, patients will again fill out the Sino-nasal Outcome Test - 22 (SNOT-22) and the surgeon will do an endoscopic assessment by using the Peri-Operative Sinus Endoscopy (POSE) scoring system .

Conditions
Nasal Polyps
Being tested
Oral Prednisone, Placebo comparator
Keywords
Nasal polyps, Steroids, Prednisone, Nasal polypectomy, Blood loss, surgical
Medical subject headings
Nasal Polyps, Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral PrednisoneDrug

    Also called steroids, corticosteroids

    Prednisone 50 mg once daily for 10 days pre-op

  • Placebo comparatorDrug

    Also called sugar pill

    Placebo pill identical to Prednisone 10 days once daily pre-op

Study groups in NCT00440219
Study groupRoleWhat they receive
Prednisone groupExperimentalPrednisone 50 mg daily for 10 days immediately pre-op
Receives: Drug: Oral Prednisone
Placebo groupPlacebo comparatorPlacebo pill for 10 days immediately pre-operative
Receives: Drug: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative blood loss. Wormald Surgical Field Grading Scale

    This is an 11-point validated scale designed to provide a standardized method of documenting bleeding in endoscopic sinus surgery [Athanasiadis et al., 2007]. In addition blood loss during the surgery will be calculated from the suction canisters after accounting for the amount of irrigation used.

    Measured: Intraoperative

  2. Visibility and easy of surgery

    The surgeon will assess visibility and easy of surgery during the surgery and the technical difficulty of the surgery using two visual analogue scale questions.

    Measured: Immediate Postoperative period

  3. Endoscopic assessment

    The Peri-Operative Sinus Endoscopy (POSE) scoring system (total score) will be used to assess the condition of the patients' sinus cavities and the Lindholdt scale will be used to provide objective measures of polyp recurrence size based on the percent obstruction of the nasal cavity and obstruction based on anatomic location.

    Measured: 4 weeks, 3 months, 6 months

Secondary outcomes (1)

  1. Quality of life survey (SNOT22)

    The Sino-nasal Outcome Test - 22 (SNOT-22) will be used as the main instrument to assess patients' disease specific symptoms. The total score from the SNOT-22 at 3 months follow-up will be the main outcome. The profile of symptom scores over the full follow-up period will be a secondary outcome.

    Measured: 2 weeks, 4 weeks, 3 months, 6 months post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2007 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2012
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440219
Sponsor's protocol ID
07-0001-A
Status last verified
Jan 2014
First submitted
22 Feb 2007
Last updated
10 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • O'Driscoll BR, Kalra S, Wilson M, Pickering CA, Carroll KB, Woodcock AA. Double-blind trial of steroid tapering in acute asthma. Lancet. 1993 Feb 6;341(8841):324-7. doi: 10.1016/0140-6736(93)90134-3.

    PubMed 8094111

  • Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19.

    PubMed 16815148

  • Johansson L, Akerlund A, Holmberg K, Melen I, Stierna P, Bende M. Evaluation of methods for endoscopic staging of nasal polyposis. Acta Otolaryngol. 2000 Jan;120(1):72-6. doi: 10.1080/000164800760370873.

    PubMed 10779190

  • Sieskiewicz A, Olszewska E, Rogowski M, Grycz E. Preoperative corticosteroid oral therapy and intraoperative bleeding during functional endoscopic sinus surgery in patients with severe nasal polyposis: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006 Jul;115(7):490-4. doi: 10.1177/000348940611500702.

    PubMed 16900802

  • Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.

    PubMed 17989575

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral Prednisone in people with Nasal Polyps, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative blood loss. Wormald Surgical Field Grading Scale (time frame: Intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00440219, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.

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