Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
248 participants
INTERVENTIONAL
2021-12-01
2024-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention with vitamin supplement
Intervention with vitamin supplement Multi-E and Multi-G
GIKAVI
Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.
Interventions
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GIKAVI
Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Zuyderland Medisch Centrum
OTHER
Responsible Party
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Principal Investigators
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Guy Vijgen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Zuyderland MC
Locations
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ZuyderlandMC
Sittard, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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van der Velden AL, Vermeer TA, Boerma EG, Belgers EH, Stoot JH, Leers MP, Sosef MN, Vijgen GH. Vitamin insufficiency after surgery for oesophagogastric neoplasms: a study protocol for a prospective intervention study. BMJ Open. 2023 Jul 4;13(7):e067981. doi: 10.1136/bmjopen-2022-067981.
Other Identifiers
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NL78919.096.21
Identifier Type: -
Identifier Source: org_study_id
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