A Comparative Study Evaluating the Impact of Intensive Dietary Care on Weight Change and Biological Parameters in Patients Who Underwent Surgery for Craniopharyngioma During the First Postoperative Year (CRANIODIET)
A Comparative Historical-prospective "Before/After" Study Evaluating the Impact of Intensive Dietary Care on Weight Change and Biological Parameters in Patients Who Underwent Surgery for Craniopharyngioma During the First Postoperative Year
Craniopharyngiomas are rare benign tumors that develop in the hypothalamic-pituitary region. Their prevalence is estimated at approximately 1 in 50,000 people in France.
The main symptoms associated with this condition are headaches and visual, neurological, and hormonal disorders. These symptoms appear when the tumors are large enough to compress adjacent structures (optic chiasm, pituitary gland, etc.).
The current standard treatment is surgical removal via endonasal approach or craniotomy, most often combined with adjuvant radiotherapy. One of the common postoperative complications is significant and rapid weight gain leading to obesity, which occurs in 26 to 61% of cases depending on the type of surgery.
These disorders can cause impulsive eating, hyperphagia, and persistent hunger, leading to deleterious metabolic consequences with an increase in comorbidities (diabetes, cardiovascular disease, joint problems, abnormal blood tests, asthma, etc.). They can also have psychosocial consequences, with a significant risk of professional and personal activity cessation during the first year after surgery due to asthenia and other possible postoperative complications (dizziness, discomfort, etc.).
In addition, this surgery alters the functioning of the pituitary gland, requiring lifelong hormone supplementation, particularly with hydrocortisone, a hormone that is essential for stress management and energy release. The optimal doses for these replacement therapies are difficult to determine. They are most often found at the end of the first year after surgery, which can then allow for a gradual resumption of normal social and professional activities and better control of health and dietary advice. This first year after surgery is therefore a pivotal year in the possible development of obesity in these patients, which justifies the importance of intensive dietary care offered to these patients as early as possible.
The investigators hypothesise that intensive dietary care could prevent weight gain and an increase in comorbidities in patients who have undergone surgery for craniopharyngioma.
The primary objective of this study is to evaluate the impact of intensive dietary care (intervention group in a prospective phase) versus usual care (control group in a retrospective pre-intervention phase) on the relative weight change in patients one year after the first resection of a craniopharyngioma.
The primary endpoint is the relative change in weight at 1 year post-surgery, i.e. the difference between the weight recorded at the last dietary consultation 1 year post-surgery and that recorded at the preoperative consultation, relative to the weight recorded at the preoperative consultation.
This study is a comparative, quasi-experimental before/after study, with a pre-control phase corresponding to patients who have undergone surgery for their craniopharyngioma and have received standard dietary management versus an interventional 'after' phase, corresponding to patients who will undergo surgery for their craniopharyngioma and who will receive intensive dietary management. The study is single-centre, with 50 patients to be recruited in the control group and 25 in the intervention group.
The expected results are to assess whether intensive dietary care (versus standard care) can limit weight gain in the year following the first removal of a craniopharyngioma, as well as its impact on socio-professional activities and the onset of comorbidities.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
Retrospective group:
- Male or female patients aged between 18 and 70 (outside this age range, the BMI criteria are different).
- Patients with craniopharyngioma who underwent initial craniopharyngioma resection surgery in Prof. Dufour's neurosurgery department at La Timone Hospital (APHM) between 1 January 2017 and 31 December 2021.
- Weight data available at 15 days, 3 months and 1 year after their initial surgery in the Electronic Patient Record (EPR).
- Patient informed and not opposed to the reuse of their data.
-
Prospective group:
- Male or female patients aged between 18 and 70 (outside this age range, the BMI criteria are different).
- Patients with craniopharyngioma in the immediate preoperative period of a first craniopharyngioma resection scheduled to be performed in Prof. Dufour's neurosurgery department at La Timone Hospital (APHM).
- Patients affiliated with or covered by a social security scheme.
- Patients who have signed a free, written and informed consent form.
- Patients who have scales at home and are able to weigh themselves.
Exclusion Criteria:
-
- Retrospective group:
- Patients with type 1 diabetes due to possible weight variation linked to a potential imbalance in diabetes.
- Patients with a history of bariatric surgery, whose weight loss could be skewed by the surgical procedure (low food intake) and by changes in the secretion of the hormones leptin (satiety hormone) and ghrelin (hunger hormone), which are possible confounding factors.
- Patients with recurrent craniopharyngioma who have a history of craniopharyngioma surgery or radiotherapy treatment for this tumour. These patients may already have hypothalamic disorders, eating disorders or weight gain following the initial removal of the craniopharyngioma.
- Adult patients under guardianship or curatorship. Pregnant or breastfeeding women.
-
Prospective group:
- Patients with memory disorders that prevent them from following dietary guidelines.
- Patients with type 1 diabetes due to possible weight variation linked to a potential imbalance in diabetes.
- Patients with a history of bariatric surgery, whose weight loss could be skewed by the surgical procedure (low food intake) and by changes in the secretion of the hormones leptin (satiety hormone) and ghrelin (hunger hormone), which are possible confounding factors.
- Patients with recurrent craniopharyngioma who have a history of craniopharyngioma surgery or radiotherapy treatment for this tumour. These patients may already have hypothalamic disorders, eating disorders or weight gain following the initial removal of the craniopharyngioma.
- Adult patients under guardianship or curatorship.
- Pregnant or breastfeeding women.
- Pregnancy (self-reported) or breastfeeding and all other categories of persons benefiting from special protection under the French Public Health Code (CSP): patients under legal protection, patients hospitalised without consent, patients admitted to social or health facilities for care and not for research, and patients in emergency situations.
- Patients unable to give informed consent or who refuse to participate in the study.
Patient already participating in an interventional study on craniopharyngioma.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Žádný zásah: Retrospective group
|
|
|
Experimentální: Prospective group
|
Intensive dietary care following surgery for a craniopharyngioma with 3 visits 2 weeks prior surgery, and 3 months after surgery associated with a follow up every 2 weeks over a year after surgery |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relative weight change at 1 year post-surgery of a craniopharyngioma
Časové okno: 1 year
|
Difference between the weight recorded at the last dietary consultation 1 year post-surgery and that recorded at the preoperative consultation, relative to the weight recorded at the preoperative consultation |
1 year
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relative weight change 15 days after surgery
Časové okno: 15 days
|
Difference between the weight recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation |
15 days
|
|
Relative weight change 3 months after surgery
Časové okno: 3 months
|
difference between the weight recorded during the dietary consultation 3 months after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation |
3 months
|
|
Relative weight change 1 year after surgery
Časové okno: 1 year
|
Difference between the weight recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation |
1 year
|
|
Absolute weight change 15 days after surgery
Časové okno: 15 days
|
Difference between the weight recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation |
15 days
|
|
Absolute weight change at 3 months post-surgery
Časové okno: 3 months
|
the difference between the weight recorded during the dietary consultation 3 months post-surgery and that recorded during the preoperative consultation |
3 months
|
|
Absolute weight change at 1 year post-surgery
Časové okno: 1 year
|
the difference between the weight recorded during the dietary consultation 1 year post-surgery and that recorded during the preoperative consultation |
1 year
|
|
Weight before surgery and then 15 days, 3 months, and 1 year after surgery
Časové okno: 15 days, 3 months and 1 year
|
Wheigh collecting on a weighing machine |
15 days, 3 months and 1 year
|
|
Absolute change in BMI 15 days after surgery
Časové okno: 15 days
|
difference between the BMI recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation |
15 days
|
|
Absolute change in BMI 3 months after surgery
Časové okno: 3 months
|
difference between the BMI recorded during the dietary consultation 3 months after surgery and that recorded during the preoperative consultation |
3 months
|
|
Absolute change in BMI at 1 year after surgery
Časové okno: 1 year
|
difference between the BMI recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation |
1 year
|
|
Relative change in BMI 15 days after surgery
Časové okno: 15 days
|
the difference between the BMI recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation |
15 days
|
|
Relative change in BMI at 3 months post-surgery
Časové okno: 3 months
|
difference between the BMI recorded during the dietary consultation 3 months post-surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation |
3 months
|
|
Relative change in BMI at 1 year after surgery
Časové okno: 1 year
|
the difference between the BMI recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation |
1 year
|
|
Percentage of patients who are overweight (BMI between 25 and 29.9 kg/m²) 15 days, 3 months and 1 year after surgery
Časové okno: 15 days, 3 months and 1 year
|
Number of patients in each BMI category (Calculation of BMI according to Quetelet's formula) 15 days, 3 months and 1 year after surgery |
15 days, 3 months and 1 year
|
|
Percentage of patients in each BMI category according to the World Health Organisation classification at 15 days, 3 months and 1 year after surgery
Časové okno: 15 days, 3 months and 1 year
|
Number of patients in each BMI category according to the World Health Organisation classification (Calculation of BMI according to Quetelet's formula) at 15 days, 3 months and 1 year after surgery. Classification is as follow:
|
15 days, 3 months and 1 year
|
|
Percentage of intermediate weight gain at each consultation
Časové okno: 1 week or 15 days
|
Result of the calculation of divided the weight at today's consultation by the weight at the last consultation |
1 week or 15 days
|
|
Percentage of patients presenting one or more biological abnormalities related to overweight or obesity (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) 15 days, 3 months, and 1 year after surgery
Časové okno: 15 days, 3 months, and 1 year
|
Number of patients presenting one or more biological abnormalities related to overweight or obesity (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) |
15 days, 3 months, and 1 year
|
|
Percentage of patients with abnormal fasting blood glucose levels 15 days, 3 months, and 1 year after surgery
Časové okno: 15 days, 3 months, and 1 year
|
Number of patients with abnormal fasting blood glucose levels |
15 days, 3 months, and 1 year
|
|
Percentage of patients with abnormal total cholesterol levels 15 days, 3 months, and 1 year after surgery
Časové okno: 15 days, 3 months, and 1 year
|
Number of patients with abnormal total cholesterol levels |
15 days, 3 months, and 1 year
|
|
Percentage of patients with abnormal HDL cholesterol levels 15 days, 3 months, and 1 year after surgery
Časové okno: 15 days, 3 months, and 1 year
|
Number of patients with abnormal HDL cholesterol levels |
15 days, 3 months, and 1 year
|
|
Percentage of patients with abnormal LDL cholesterol levels 15 days, 3 months, and 1 year after surgery
Časové okno: 15 days, 3 months, and 1 year
|
Number of patients with abnormal LDL cholesterol levels |
15 days, 3 months, and 1 year
|
|
Percentage of patients with abnormal triglyceride levels at 15 days, 3 months, and 1 year after surgery
Časové okno: 15 days, 3 months, and 1 year
|
Number of patients with abnormal triglyceride levels |
15 days, 3 months, and 1 year
|
|
Change in quality of life compared to the preoperative dietary consultation, 15 days, 3 months and 1 year after surgery
Časové okno: 15 days, 3 months and 1 year
|
Analysis of quality of life questionnaires (WHOQOL-BREF) |
15 days, 3 months and 1 year
|
|
Total energy intake
Časové okno: 15 days, 3 months and 1 year
|
Assessment of total energy intake calculated from dietary intake, including proteins, lipids and carbohydrates.Unit of Measure: kcal |
15 days, 3 months and 1 year
|
|
Questionnaire on eating behaviour and feelings about food (DEBQ), pre-operatively, then 15 days, 3 months and 1 year after surgery
Časové okno: 15 days, 3 months and 1 year
|
Analysis of the Dietary Behaviour and Eating Feelings Questionnaire (DEBQ) |
15 days, 3 months and 1 year
|
|
Analysis of body composition (fat mass, lean mass) using an impedance meter (In Body device) 15 days, 3 months and 1 year after surgery
Časové okno: 15 days, 3 months and 1 year
|
Impedance measurement |
15 days, 3 months and 1 year
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- RCAPHM23_0030
- ID RCB: 2024-A00186-41 (Jiný identifikátor: ANSM)
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