Clinical Trial

Prediction Model for Postoperative Headache After Transsphenoidal Pituitary Surgery

Active, Not Recruiting
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Summary
Primary Objective: This observational study aims to construct a predictive model for short-term headache following endonasal pituitary adenoma surgery and to identify risk factors associated with postoperative headache after endonasal surgery. Secondary Objectives: First, to investigate the relationship between the severity of short-term postoperative headache and long-term life burden (at 1 and 3 months postoperatively), as well as its correlation with quality of life. Second, to elucidate the clinical characteristics and evolutionary patterns of short-term postoperative headache. Third, to explore key aspects of perioperative management, including changes in nasal cavity status and postoperative mobilization, which may optimize the management of short-term postoperative headache. Primary outcome measure1: VAS scale(0-10) Primary outcome measure2: feature of postoperative headache including (location, type, length, accompany symptom, and factors that elevate or sharpen headache, analgesics usage, analgesics frequency, analgesics effect) Secondary outcome measure 1: HIT-6 test Secondary outcome measure 2: Postoperative Olfaction Secondary outcome measure 3: Postoperative Massive Epistaxis Participants will undergo daily assessments postoperatively, which include evaluations of headache, nasal cavity status, and analgesic drug usage. These assessments will continue until two consecutive Visual Analog Scale (VAS) scores are less than 4. Additionally, participants will complete questionnaires, including the Headache Impact (HIT-6) test at 4 weeks and 12 weeks postoperatively.
Trial Details
NCT Number NCT07446036
Lead Sponsor Beijing Tiantan Hospital
Conditions Headache, Pituitary Adenoma, Endonasal Surgery, Predictive Model
Enrollment 500 participants
Start Date 2026-01-01
Primary Completion 2026-08 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-03