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NCT Number: NCT05659524

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

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.

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Key information

Conditions

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

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

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About this study

This prospective study, coupled with the results of the recent POET study evaluating the role of antibiotics in postoperative outcomes for pituitary surgery, will guide physicians in the optimal management of patients following endoscopic pituitary surgery.

The investigator group has an established record of completing multicenter studies (e.g., POET, TRANSPHER) that have influenced clinical practice guidelines, raised the profile of Barrow in the pituitary and skull base community, and resulted in numerous peer-reviewed publications and awards.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • History of radiation to the skull base

Treatment and study plan

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.

Primary outcomes

  1. Difference in mean sinonasal quality of life

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Endoscopy findings

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Malika Bhargava

CONTACT

[email protected]

602-406-7121

Val Calores

CONTACT

[email protected]

602-406-8772

Sponsors and collaborators

Lead sponsor

Lori Wood

Other

Collaborators

  • Barrow Brain and Spine

Registry information

Official study title

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial

Acronym: NOSE

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Dec 21, 2022
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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