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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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

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Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Prednisone group

Prednisone 50 mg daily for 10 days immediately pre-op

Group Type EXPERIMENTAL

Oral Prednisone

Intervention Type DRUG

Prednisone 50 mg once daily for 10 days pre-op

Placebo group

Placebo pill for 10 days immediately pre-operative

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

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

Interventions

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Oral Prednisone

Prednisone 50 mg once daily for 10 days pre-op

Intervention Type DRUG

Placebo comparator

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

Intervention Type DRUG

Other Intervention Names

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steroids corticosteroids sugar pill

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No