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NCT01968603 Clinical Trial

Weight Gain in Surgically Treated Adult-onset Craniopharyngioma

Adult-onset Craniopharyngioma Clinical Trial

Official title:
Weight Gain in Surgically Treated Adult-onset Craniopharyngioma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01968603
Other study ID # KY2013-315
Secondary ID
Status Completed
Phase N/A
First received October 20, 2013
Last updated October 20, 2013
Start date July 2013
Est. completion date October 2013

Study information
Verified date October 2013
Source Huashan Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.

Description:

Morbid obesity, intractable weight gain due to hypothalamic damage, is a common and troubling complication in patients undergoing surgery for craniopharyngioma combined or not with radiotherapy, with an incidence of 23~62% in pediatric patients. It has a major negative impact on metabolic and cardiovascular health and quality of life in long-term survivors. Identifying patients at higher risks for developing postoperative weight gain is of great importance in preventing obesity and taking early actions in this population. Though a lot of previous studies have been made in pediatric patients and several factors, such as hypothalamic involvement, higher body mass index (BMI) standard deviation score (SDS) at diagnosis, age at diagnosis and hydrocephalus requiring a shunt, have been identified as risk factors for postoperative weight gain, data on this important morbidity in adult-onset patients are sparse, especially in Chinese population. Therefore, the investigators are going to undertake a retrospective evaluation of postoperative weight change in adult-onset patients undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 81 Years
Eligibility Inclusion Criteria:

adult-onset, aged 18 years or more; pathologically confirmed craniopharyngioma; primary surgery performed at our hospital; at least 3 months of follow-up including body weight measurement; ambulatory (since lack of ambulation may predispose to weight gain); not receiving supraphysiologic doses of glucocorticoid (e.g. hydrocortisone, prednisone, or dexamethasone to exceed 12mg/m2•d hydrocortisone equivalent) for more than 2 months after tumor therapy.

Exclusion Criteria:

Childhood-onset, <18 years old; Inconsistent pathology; Without follow-up records in the investigators' institution.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Endocrinology and Metabolism Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of postoperative weight gain 2.5 years No