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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status and phase: Completed; Phase 3

Conditions: Nasal Polyps

Treatments: Drug: Oral Prednisone; Drug: Placebo comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT00440219

07-0001-A

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Prednisone group

Experimental group

Description:

Prednisone 50 mg daily for 10 days immediately pre-op

Treatment:

Drug: Oral Prednisone

Placebo group

Placebo Comparator group

Description:

Placebo pill for 10 days immediately pre-operative

Treatment:

Drug: Placebo comparator