Weight Gain in Surgically Treated Adult-onset Craniopharyngioma

October 20, 2013 updated by: Zhaoyun Zhang, Huashan Hospital
The aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Department of Endocrinology and Metabolism

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

18 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult-onset patients with craniopharyngioma undertaking primary surgery in the investigators' institution

Description

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 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
Time Frame
percentage of postoperative weight gain
Time Frame: 2.5 years
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Li yi ming, Huashan Hospital

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

July 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 20, 2013

First Submitted That Met QC Criteria

October 20, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 20, 2013

Last Verified

October 1, 2013

More Information

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.

Clinical Trials on Adult-onset Craniopharyngioma

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