RecruitingACTRN12621000857808

Validation of a Postoperative Diabetes Insipidus Prediction Tool In Patients Undergoing Skull Base Surgery

Validating the SALT Score for Prediction of Postoperative Diabetes Insipidus after Endoscopic Endonasal Skull Base Surgery

Sponsor

Mendel Castle-Kirszbaum

Enrollment

100 participants

Start Date

Jun 1, 2021

Study Type

Observational

Conditions

Diabetes Insipidus

Summary

We aim to prospectively validate a scoring system, the SALT score, in a cohort of patients with anterior skull base tumours undergoing endoscopic endonasal skull base surgery. We will assess how much patients drink and urinate in the days after surgery, as well as routine blood tests, to establish if patients develop diabetes insipidus, a condition where patients are not able to concentrate their urine. We will then assess whether the SALT score was able to predict which patients developed diabetes insipidus.

Eligibility

Sex: Both males and femalesMin Age: 10 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a scoring system called the SALT score to see how well it predicts which patients will develop diabetes insipidus (DI) after surgery on the skull base to remove pituitary tumours. Diabetes insipidus is a condition where the body cannot properly regulate urine concentration, leading to excessive urination and thirst — it is a known complication of certain brain surgeries. Researchers will closely monitor patients' fluid intake, urine output, and routine blood tests in the days following endoscopic endonasal (through the nose) skull base surgery. This data will be used to determine which patients develop DI, and then compared against the SALT score calculated before and during surgery to assess how accurate the prediction tool is. To be eligible, you need to have an anterior skull base condition (such as a pituitary tumour) that has been recommended for this specific surgical approach by a multidisciplinary team. Patients who already have diabetes insipidus before surgery are not eligible. This study is being run by a neurosurgical team and there is no experimental treatment involved — researchers are simply observing outcomes and validating the predictive tool.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will be subject to standard of care. Patients operated on for anterior skull base pathology will be scored based on imaging characteristics and intraoperative findings. The development of postoperative diabetes insipidus will be recorded in order to prospectively validate a novel predictive scoring system for the development of diabetes insipidus after endoscopic endonasal skull base surgery. The SALT score, presented here (PMID: 34041659) is a simple scoring system based on suprasellar extension of tumour, craniopharyngioma histology, Age <50y, and intraoperative Kelly grade 3 leak. Imaging is a preoperative volumetric gadolinium enhanced pituitary MRI and volumetric non-contrast CT brain. Both imaging modalities are performed in the week prior to surgery.