- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708523
Next Day Growth Hormone Predicting Pituitary Function After Adenomectomy
October 14, 2018 updated by: National Taiwan University Hospital
Next Day Early Morning Growth Hormone as Predictor of Pituitary Function After Transsphenoidal Adenomectomy
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.
Study Overview
Status
Unknown
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fon-Yih Tsuang
- Phone Number: 0972651142
- Email: tsuangfy@gmail.com
Study Locations
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Taipei city, Taiwan, 100
- National Taiwan University Hospital
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Contact:
- Fon-Yih Tsuang, MD
- Phone Number: 0972651142
- Email: tsuangfy@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who had been treated with TSA were enrolled.
Description
Inclusion:
Patients who had been treated with TSA were enrolled.
Exclusion:
- Hypopituitarism preoperatively.
- Acromegaly
- Multiple operations
- Incomplete hormone data or loss of follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Next Day Early Morning Growth Hormone as Predictor of Pituitary Function After Transsphenoidal Adenomectomy
Time Frame: 2 days
|
To predict the morning postoperative cortisol levels, for further prediction of the postoperative pituitary function.
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2018
Primary Completion (ANTICIPATED)
September 1, 2019
Study Completion (ANTICIPATED)
September 1, 2019
Study Registration Dates
First Submitted
October 14, 2018
First Submitted That Met QC Criteria
October 14, 2018
First Posted (ACTUAL)
October 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 17, 2018
Last Update Submitted That Met QC Criteria
October 14, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201809035RIND
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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