C15.9
Conditions
Interventions
Group 1: Male patients suffering from distal esophageal carcinoma and undergoing elective esophagectomy after neoadjuvant chemotherapy
Sponsors
Unimedizin Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Elective surgery, oral food intake must be preserved, defecation via naturalis, omnivorous diet, neoadjuvant pre-treatment planned, M0 or clinical stage I to IVa, any tumor location in the esophagus (cervical, thoracic, esophagogastric junction)
Exclusion criteria
Exclusion criteria: Female gender, children and adolescents, emergency surgery, no oral food intake possible, anus praeter, lack of compliance, cognitive impairment (e.g. dementia), vegetarian or vegan diet, previous illnesses associated with chronic diarrhoea, known food intolerance leading to diarrhoea, long-term treatment with laxatives, primary surgery without pre-treatment, palliative treatment, presence of distant metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alpha diversity (measured by Shannon index) of the stool microbiome at initial diagnosis and after neoadjuvant pretreatment as well as 10 days and 3 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Further indices for quantifying a-diversity (Chao1, Simpson, Fisher) and ß-diversity (Bray-Curtis, weighted and unweighted UniFrac) at all times Influence of socio-demographic factors on the composition of the microbiome Abundance of bacterial taxa at phylum, genus and species level Influence of the histological differentiation of the tumor (squamous cell carcinoma vs. adenocarcinoma) on the composition of the microbiome Influence of neoadjuvant pre-treatment on the composition of the microbiome Metabolomic analysis of amino acid and folate metabolism and the Krebs cycle Sociodemographic parameters: Age, underlying disease, origin, comorbidities, previous surgeries, long-term medication (especially opiates and pantoprazole as well as preoperative antibiotic administration), diet, alcohol and nicotine consumption (current and history, extent of consumption) Clinical parameters: - Well-being via a numerical analog scale (1-10) - Pain (using a numerical analog scale (1-10)) - Nausea (yes vs. no) and vomiting (yes vs. no) - Nature of bowel movements (using the Bristol stool chart), occurrence of fatty stools - Frequency of diarrhea (several times a day - once a day - several times a week - once a week - several times a month - once a month - less than once a month) - Current weight, height, weight loss (yes vs. no), extent of weight loss or weight gain, evaluation of nutritional status - Has nutritional counseling been carried out (yes vs. no), if yes, when was the nutritional counseling carried out (before or after initial diagnosis), if no, is nutritional counseling planned (yes vs. no) or why not (free text) - Evaluation of a nutrition log at all four examination times (total calories, intake of carbohydrates, fats, protein, fiber, vitamins and other nutrients) - Evaluation of the body composition (via a bio-impedance measurement and via the evaluation of the available computer tomography carried out as part of the staging) at all four examinat | — |
Countries
Germany
Contacts
Public ContactAnn-Kathrin Lederer
Unimedizin Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Outcome results
None listed