Prediction Model for Postoperative Headache After Transsphenoidal Pituitary Surgery
Key facts
- Who runs it
- Beijing Tiantan Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 500 people, planned
- Started
- 1 Jan 2026
- Expected to end
- Dec 2026
- Type of study
- Observational
- Treatments tested
- Transsphenoidal Pituitary Surgery
- Record updated
- 3 March 2026
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age ≥ 18 years old
- Preoperatively diagnosed with pituitary adenoma by clinical and radiological (MRI) evaluation, and scheduled to undergo primary or recurrent neuroendoscopic transsphenoidal surgery in the Tumor Ward 7 of the Department of Neurosurgery at Beijing Tiantan Hospital
- Fully conscious with adequate cognitive and comprehension abilities to complete pain assessment scales (VAS) and questionnaires (HIT-6, psychological scales, etc.)
- Willing to participate in this study and provide written informed consent
Who cannot take part
- Presence of other intracranial tumors, or undergoing transsphenoidal surgery due to other diseases (such as aneurysms, Rathke's cysts, meningiomas, etc.)
- History of chronic headache (such as migraines, tension headaches) with a frequency of >4 times per month, or long-term dependence on analgesic medications
- Presence of severe nasal or sinus diseases preoperatively (such as chronic sinusitis requiring surgical intervention, nasal polyps) or a history of nasal surgery within the recent 3 months
- History of severe psychiatric or psychological disorders, or presence of cognitive impairment or language communication barriers that prevent participation in study assessments
- Conversion to craniotomy during surgery due to various reasons (such as uncontrollable bleeding, change in tumor nature)
- Pregnant or breastfeeding women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- postoperative short-term headache
patient with postoperative short-term headache is defined as a VAS peak score ≥ 4 within two weeks postoperatively；
Treatment: Transsphenoidal Pituitary Surgery
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Analysis of Risk Factors for Short-term Postoperative Headache and Construction of a Prediction Model After Transsphenoidal Surgery for Pituitary Adenoma: A Prospective Cohort Study
- Record updated
- 3 March 2026