Prediction Model for Postoperative Headache After Transsphenoidal Pituitary Surgery

NCT07446036 | Active Not Recruiting

• 1 other identifier: HX-B-2025100
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Pituitary Adenoma; Endonasal Surgery; Predictive Model

Keywords

pituitary adenoma; endonasal surgery; headache

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  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.

  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.

Secondary Outcomes (3)

• 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

Other Outcomes (3)

• Length of Postoperative Headache

  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.

• Location of Postoperative Headache

  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.

• Analgesics frequency

  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.

Study Arms (1)

postoperative short-term headache

patient with postoperative short-term headache is defined as a VAS peak score ≥ 4 within two weeks postoperatively；

Procedure: Transsphenoidal Pituitary Surgery

Interventions

Transsphenoidal Pituitary Surgery PROCEDURE

all pituitary cases recruited in the study received transsphenoidal pituitary surgery

postoperative short-term headache

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects of this study are patients with pituitary adenomas undergoing neuroendoscopic transsphenoidal surgery at Beijing Tiantan Hospital from March to December 2026.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Fengtai, 100071, China

Location

MeSH Terms

Conditions

Headache; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Peng Li, Phd

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 3, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (1)