No registrations found.
ID
Source
Health condition
Craniopharyngioma; (Hypothalamic) Obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
% Weight change
Secondary outcome
Changes in pituitary replacement therapy
Background summary
Craniopharyngioma is a sellar tumour associated with high rates of pituitary deficiencies (~98%) and hypothalamic obesity (~50%). It is unknown whether long-term weight loss can be established with bariatric surgery in obese craniopharyngioma patients with hypothalamic dysfunction. Therefore, we perform a multicenter retrospective study where we compare weight loss after 1, 2, 3, 4 and 5 years in patients with hypothalamic obesity due to craniopharyngioma, with matched obese controls from the Scandinavian Obesity Surgery Registry, a nationwide registry. Controls have follow-up data available at 6 weeks, and 1, 2 and 5 years. Linear interpolation is performed for any missing values in patients or controls. The matching procedure is extensive: controls are selected according to gender, type of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy), pre-operative T2DM, and pre-operative hypertension. Further matching is performed by year of obesity operation (10-year span category), age at obesity operation (10-year span category), and pre-operative body mass index (BMI) (maximum of ±5 kg/m2 different from the control). Controls are included only once. If less than 10 controls can be found, the matching terms are slightly broadened: the criterion for matching age at bariatric surgery is extended to ±10 years of the patient's age instead of a certain age category. In case of extreme BMI, the limt for BMI are not applied. Baseline statistics are compared between patients with obesity after craniopharyngioma and the matched controls from the SOReg database by Mann-Whitney U-test and Fisher's exact test for continuous and categorical data, respectively, and related continuous data are evaluated with Wilcoxon's rank test. Percentage weight change is then compared with a one-factor generalised randomised block design, with two-way analysis of variance applied with matched case-control units included as blocks. Blootstrapping is performed if this is needed to meet the assumptions of the test. Furthermore, the changes in pituitary replacement therapy are described.
Study objective
We hypothesize that patients with craniopharyngioma and hypothalamic obesity have less efficacy of bariatric surgery compared to controls from a 'general' obese population
Study design
1, 2, 3, 4, 5 years follow-up
Intervention
Matched case control study: obese patients with craniopharyngioma and bariatric surgery are compared to obese controls with bariatric surgery and no history of craniopharyngioma
Inclusion criteria
Patients with craniopharyngioma who underwent bariatric surgery and have at least 2 years of follow-up
Exclusion criteria
-
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9374 |
Other | METC Erasmus MC : - |