Next Day Growth Hormone Predicting Pituitary Function After Adenomectomy

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03708523
Collaborator
(none)
400
1
10
40

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Retrospective
    Official Title:
    Next Day Early Morning Growth Hormone as Predictor of Pituitary Function After Transsphenoidal Adenomectomy
    Anticipated Study Start Date :
    Nov 1, 2018
    Anticipated Primary Completion Date :
    Sep 1, 2019
    Anticipated Study Completion Date :
    Sep 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Next Day Early Morning Growth Hormone as Predictor of Pituitary Function After Transsphenoidal Adenomectomy [2 days]

      To predict the morning postoperative cortisol levels, for further prediction of the postoperative pituitary function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei city Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Fon-Yih Tsuang, MD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03708523
    Other Study ID Numbers:
    • 201809035RIND
    First Posted:
    Oct 17, 2018
    Last Update Posted:
    Oct 17, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 17, 2018