After surgery for esophageal cancer and gastric cancer micronutrient deficiencies are common and standard suppletion to prevent deficiencies should be performed.
ID
Bron
Verkorte titel
Aandoening
Esophageal cancer and gastric cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To identify which micronutrient deficiencies are most common after surgery for esophagogastric neoplasms and to observe the effect of supplementation.
Achtergrond van het onderzoek
Rationale: Esophageal cancer and gastric cancer are among the top ten most common cancers worldwide. Both diseases have major impact on the nutritional status of patients and their quality of life. Studies investigating post-operative nutritional status are limited and postoperative identification and treatment of micro- and macronutritional deficiencies are currently lacking in (inter-)national guidelines.
Objective: To identify and target vitamin deficiencies after surgery for esophagogastric neoplasms.
Study design: Single centre intervention study.
Study population: Patients aged 18 years and older that underwent esophagectomy or (sub- )total gastrectomy for esophagogastric neoplasms.
Intervention (if applicable): Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.
Main study parameters/endpoints: Baseline micronutrient deficiency measurements and after 6, 12, 24 months supplementation,.
Secondary study parameters/ endpoints: Occurrence of exocrine pancreatic insufficiency (n,%), occurrence of diarrhoea (n,%), steatorrhea (n,%), bloating (n,%), time between surgery and start of supplementation (mean in months), quality of life experienced (questionnaires) at baseline and after 6, 12, 24 months supplementation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no health-related risks are present for participants due to the administration of supplementation that is already used as in clinical practice.
Doel van het onderzoek
After surgery for esophageal cancer and gastric cancer micronutrient deficiencies are common and standard suppletion to prevent deficiencies should be performed.
Onderzoeksopzet
Baseline micronutrient deficiency measurements and after 6, 12, 24 months supplementation.
Onderzoeksproduct en/of interventie
Administriation of two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
A potential subject who meets any of the following criteria will be included for participation in this study:
- Patients ≥18 years of age who underwent an esophagectomy or (sub)total gastrectomy for malignancy with no signs of postoperative recurrence of disease.
- Written voluntary informed consent (IC).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients that underwent a wedge resection of the stomach
- Malignant disease recurrence
- Metastases
- Patients that are not capable to take supplementation due to altered mental status or
swallow difficulties
- No signed informed consent
- Patients who are receiving chemotherapy
- Patients with high vitamin status at baseline
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9787 |
| Ander register | METC Zuyderland : METCZ20210146 |