دورية أكاديمية
أعرض في EDS

Vitamin insufficiency after surgery for oesophagogastric neoplasms: a study protocol for a prospective intervention study.

التفاصيل البيبلوغرافية
العنوان: Vitamin insufficiency after surgery for oesophagogastric neoplasms: a study protocol for a prospective intervention study.
المؤلفون: van der Velden AL; Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands l.vandervelden@zuyderland.nl., Vermeer TA; Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Boerma EG; Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Belgers EH; Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Stoot JH; Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Leers MP; Clinical Chemistry & Hematology, Zuyderland Medical Centre, Heerlen, The Netherlands., Sosef MN; Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Vijgen GH; Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
المصدر: BMJ open [BMJ Open] 2023 Jul 04; Vol. 13 (7), pp. e067981. Date of Electronic Publication: 2023 Jul 04.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Vitamins*/therapeutic use , Esophageal Neoplasms*/surgery, Humans ; Quality of Life ; Prospective Studies ; Calcium ; Calcium, Dietary
مستخلص: Introduction: Oesophageal cancer (EC) and gastric cancer (GC) are among the top 10 cancers worldwide. Both diseases impact the nutritional status of patients and their Quality of Life (QoL). Preoperative malnutrition is reported in 42%-80%. However, studies investigating postoperative nutritional status are limited, and postoperative identification and treatment of micronutrient and macronutrient deficiencies are currently lacking in (inter-)national guidelines. The aim of this study is to identify and target micronutrient deficiencies after surgery for oesophagogastric neoplasms.
Methods: This is a single-centre prospective intervention trial performed in Zuyderland Medical Centre. 248 patients who underwent oesophagectomy (n=124) or (sub)total gastrectomy (n=124) from 2011 until 2022 will be included. Both groups will receive Calcium Soft Chew D3 and a multivitamin supplement (MVS) specifically developed according to the type of operation patients underwent; the oesophagectomy group will receive Multi-E and the gastrectomy group will receive Multi-G. The MVSs will be taken once daily and Calcium Soft Chew D3 two times per day. Supplementation will start after baseline measurements. At baseline (T0), blood withdrawal for micronutrient analysis and faecal elastase-1 analysis for exocrine pancreatic insufficiency (EPI) will be performed. Additionally, patients will receive questionnaires regarding QoL and dietary behaviour. After 180 days of supplementation (T1), baseline measurements will be repeated, and the supplement tolerance questionnaire will be completed. Measurements will also be conducted after 360 days (T2) and after 720 days (T3) of supplementation. The main study parameter is micronutrient deficiency (yes/no) for all measurements. Secondary parameters include occurrence of EPI (n, %), diarrhoea (n, %), steatorrhoea (n, %) or bloating (n, %), time between surgery and start of supplementation (mean in months), and QoL at all time points.
Ethics and Dissemination: The study was approved by the Zuyderland Medical Centre Ethics Committee, Heerlen, the Netherlands. The findings will be disseminated through scientific congresses and in peer-reviewed journals.
Trial Registration Number: NCT05281380.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: gastrointestinal tumours; malabsorption; nutritional support; oesophageal disease; surgery
سلسلة جزيئية: ClinicalTrials.gov NCT05281380
المشرفين على المادة: 0 (Vitamins)
SY7Q814VUP (Calcium)
0 (Calcium, Dietary)
تواريخ الأحداث: Date Created: 20230705 Date Completed: 20230707 Latest Revision: 20230718
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC10335568
DOI: 10.1136/bmjopen-2022-067981
PMID: 37407040
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2022-067981