Health TrialsbyHealthPanel

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

ConditionPituitary Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorLori Wood

About this trial

This is a prospective, single-blinded, multicenter study evaluating the benefit of sinonasal irrigations following endoscopic pituitary surgery. The goal of this study is to create practice changing guidelines with objective data highlighting the importance of irrigations on postoperative outcomes for pituitary surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient undergoing endoscopic surgery for resection of pituitary tumors

nonfunctioning adenoma

acromegaly

prolactinoma

Disqualifiers

Active sinus infection

Allergic rhinitis

Asthma

Vascular or inflammatory disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nasal saline irrigation

    Other intervention

    The following nasal care recommendations have been approved by the study protocol committee for patients randomized to the treatment arm with saline irrigations: * Postoperative days 1 through 3: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. * Postoperative day 3 to week 12: patients will begin twice daily sinus irrigation rinse (e.g., NeilMed Sinus Rinse). They will perform 240 mL sinus rinses BID. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Nasal saline irrigationActive comparator 1 intervention
Group B: No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Difference in mean sinonasal quality of life

Difference in mean sinonasal quality of life between groups as determined by patient reported Sino-nasal Outcome Test (SNOT-22) scores at 4 weeks. SNOT-22 scoring can be completed during a clinic visit or by phone interview. It is critical that the follow-up times are standardized because symptoms improve with time. A reduction in SNOT-22 composite score is indicative of improvement in symptoms.

Time frame
12 weeks

Secondary outcomes

1

Endoscopy findings

Postoperative nasal endoscopy findings of purulence, nasal crusting, polyps, and synechiae as estimated on the Endoscopic Appearances scale developed by Lund- Kennedy at 1 week, 4 weeks, and 12 weeks after surgery.

Time frame
12 weeks
2

Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores

Sinonasal quality of life as determined by patient-reported ASK Nasal-12 scores at 1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after surgery.

Time frame
12 weeks
3

Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22)

Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) overall scores at 1week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery.

Time frame
12 weeks
4

Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores

Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores at 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lori Wood

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Sponsor institution

Barrow Brain and Spine

Collaborator

Source ClinicalTrials.gov
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