Prospective Quality of Life Study in Pituitary Surgery

University of Virginia

Status: Unknown

Conditions: Endoscopic Skull Base Surgery; Postoperative Period; Post Operative Care

Treatments: Other: Follow-up schedule

Study type: Observational

Funder types: Other

Identifiers

NCT03694990

20758

Details and patient eligibility

About

Post-operative assessment and debridement are key components in patient care for surgery patients. However, a standardized protocol for management after endoscopic skull base surgery is unavailable. In this study, investigators will observe the effect of various follow-up schedules on the patient's quality of life after surgery. Patients who received surgery for pituitary adenoma will be placed randomly in 1 of 3 groups (short-term = follow-up in 2 weeks and 8 weeks after surgery; intermediate = 4 weeks and 8 weeks; long-term = 8 weeks). At each visit, patients will be asked to complete a packet of surveys and questionnaires that provide metrics on their quality of life in addition to receiving standard patient care (post-operative assessment and nasal debridement). Researchers hope to find that a follow-up schedule that has patients visiting the clinic closer to their surgery date will increase the patient's quality of life after surgery.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has surgery for pituitary adenoma at UVA after May 1st, 2018
• Has sellar and parasellar pathology
• ≥ 18 years old
• Can complete all parts of study in English

Exclusion criteria

• Extended approaches
• Use of naso-septal flap during the current surgical procedure
• Septoplasty
• Prior history of Chronic Rhinosinusitis (CRS)
• Prior history of sphenoidotomy
• < 18 years old
• Prisoner

Trial design

165 participants in 3 patient groups

Short-term

Description:

Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery.

Treatment:

Other: Follow-up schedule

Intermediate

Description:

Patients will be scheduled for PO follow-up visits 4 weeks, and 8 weeks after surgery.

Treatment:

Other: Follow-up schedule

Long-term

Description:

Patients will be scheduled for PO follow-up visits 8 weeks after surgery.

Treatment:

Other: Follow-up schedule