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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS)
Study Overview
Brief 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.
Detailed Description
1. Quality Control and Assurance of the Study
To ensure the authenticity, integrity, and accuracy of the study data, as well as to ensure that the study process fully complies with the protocol and ethical standards, the following quality control and assurance measures have been established:
1.1 Development and Implementation of Standard Operating Procedures (SOPs)
- . Study-specific SOP: A dedicated Clinical Research Data Collection Standard Operating Procedure will be developed for this study. It will clearly define the definitions, collection methods, time points, and recording standards for each observation indicator (e.g., VAS scoring instructions, nasal patency grading criteria).
- . Data entry SOP: Norms for entering data into the electronic data capture system will be established to ensure that data is transferred from case report forms to the database in a timely, accurate, and consistent manner.
1.2 Investigator Training and Consistency Assessment
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Pregnant or breastfeeding women.
- •Conversion to craniotomy during surgery due to various reasons (such as uncontrollable bleeding, change in tumor nature).
Arms & Interventions
postoperative short-term headache
patient with postoperative short-term headache is defined as a VAS peak score ≥ 4 within two weeks postoperatively；
Intervention: Transsphenoidal Pituitary Surgery (Procedure)
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS)
Time Frame: Postoperative assessments shall be performed daily from Day 1, continuing until two consecutive VAS scores below 4 are obtained or until two weeks postoperatively, whichever occurs first.
The Visual Analogue Scale (VAS) is scored from 0 to 10, with higher scores denoting greater headache severity. Postoperative short-term headache is defined as the occurrence of two consecutive peak VAS scores ≥4 within the two-week postoperative period.
Secondary Outcomes
- Headache Impact Test (HIT-6)(4 weeks postoperatively and 12 weeks postoperatively)
- Rate of Postoperative Olfaction(4 weeks and 12 weeks postoperatively)
- Rate of Postoperative Massive Epistaxis(4 weeks and 12 weeks postoperatively)