Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

NCT05659524 | Recruiting DMC

• 1 other identifier: PHX-20-500-189-30-12
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pituitary Tumor

Outcome Measures

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.

  12 weeks

Secondary Outcomes (5)

• Endoscopy findings

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

• Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction.

  12 weeks

Study Arms (2)

Nasal saline irrigation

ACTIVE COMPARATOR

Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations

Other: Nasal saline irrigation

No Intervention

NO INTERVENTION

Patients randomized to not performing saline sinonasal irrigations.

Interventions

Nasal saline irrigation OTHER

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.

Nasal saline irrigation

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient undergoing endoscopic surgery for resection of pituitary tumors
• nonfunctioning adenoma
• acromegaly
• prolactinoma
• Rathke's cleft cyst
• Adults \>18 and \<85 years of age
• English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales
• Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable
• Planned binostril surgical approach
• Either with or without septal flap reconstruction
• Either with or without septoplasty

You may not qualify if:

• Active sinus infection
• Allergic rhinitis
• Asthma
• Vascular or inflammatory disease
• History of previous sinonasal surgery
• Any subject who is unwilling or unable to sign informed consent for the study
• Pregnancy
• Incarcerated patients
• Cushing's disease
• History of chronic sinusitis
• Extended approaches to the skull base
• Active sinusitis
• Nasal polyps
• Concurrent antibiotics for another indication (i.e., urinary tract infection)
• Immunodeficiency

Sponsors & Collaborators

• Lori Wood: lead
• Barrow Brain and Spine: collaborator

Study Sites (2)

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Central Study Contacts

Val Calores

CONTACT

602-406-8772; Val.calores@dignityhealth.org

Malika Bhargava

CONTACT

602-406-7121; Malika.Bhargava@dignityhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The study will be blinded to the Otolaryngologist involved in the study. The research team and the patient will not be blinded. The goal of blinding the Otolaryngologist is to minimize the bias in grading the Lund Kennedy endoscopic scores which are a subjective metric interpreted in the office setting.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Operations Manager of Neurosurgery Research

Model Details: Multicenter randomized single-blinded, intervention trial involving 70 patients from this site (140 treated patients total from all sites), undergoing endoscopic transsphenoidal surgery for pituitary lesions. The same cohort will simultaneously be used to evaluate the role of sinonasal irrigations in those patients who undergo nasoseptal flap reconstructive procedures as part of their treatment.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 21, 2022
• Study Start: December 18, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)