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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03708523
Other study ID # 201809035RIND
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date September 2019

Study information

Verified date October 2018
Source National Taiwan University Hospital
Contact Fon-Yih Tsuang
Phone 0972651142
Email tsuangfy@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study tried to highlight the predictive value of the morning postoperative cortisol levels, which can act as the prognosis value of the postoperative pituitary function, providing future medication advices for improving patients' safety of drugs.


Description:

Transsphenoidal adenomectomy usually accompanied by the failure or recovery of the pituitary gland, which usually causing further hypopituitarism and hormone recovery. In order to prevent the potential applications of adrenal cortical malfunction after the surgery, many medical centers will use glucocorticoid supplements during the perioperative period care. However, this treatment might expose the normal hypothalamic-pituitary-adrenal (HPA) axis function patients into potential threats after the treatment of glucocorticoid supplements, such as bone loss, hypertension, emotional distress, and weight gain. To avoid unnecessary supply of glucocorticoids, the key question is to monitor the pituitary function. Thus, in this study we try to predict the morning postoperative cortisol levels, for further prediction of the postoperative pituitary function. To do so, we will review the retrospective charts of transsphenoidal adenomectomied patients from January, 2013 to April, 2018 in the NTUH Taipei. Use statistical methods analyzing all sorts of medical reports, including perioperative hormone thresholds.This study tried to highlight the predictive value of the morning postoperative cortisol levels, which can act as the prognosis value of the postoperative pituitary function, providing future medication advices for improving patients' safety of drugs.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion:

Patients who had been treated with TSA were enrolled.

Exclusion:

1. Hypopituitarism preoperatively.

2. Acromegaly

3. Multiple operations

4. Incomplete hormone data or loss of follow-up

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei city

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Next Day Early Morning Growth Hormone as Predictor of Pituitary Function After Transsphenoidal Adenomectomy To predict the morning postoperative cortisol levels, for further prediction of the postoperative pituitary function. 2 days
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