Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT04189393
Eligibility Criteria:
Inclusion Criteria:
* Patients with proven malignancy of the distal esophagus, pancreatic head/corpus, colon or rectum
* Patients undergoing primary elective surgery with construction of an anastomosis of the gastrointestinal tract
* Adult patients above age 18 years
* Written informed consent
Exclusion Criteria:
* History of chronic gastro-intestinal disease e.g. Crohns disease and ulcerative colitis
* Presence of acute gastrointestinal infection
* Chronic use of oral antibiotics (3 months or longer)
* Patients undergoing gastrointestinal surgery for gastrointestinal cancer in acute setting
* Patients undergoing construction of an end/loop colostomy or ileostomy (following primary resection)
* Patients undergoing colon and/ or rectal resection without construction of an anastomosis
* Patients who have insufficient knowledge of the Dutch language
* Patients who are not able to give reliable answers to the questionnaires due to a (mental) disease or (cognitive) condition
* Patients who are not able to collect microbiome samples due to a physical or mental condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04189393
Study Brief:
Protocol Section:
NCT04189393