Common use of Study Design Clause in Contracts

Study Design. This is a randomized, multicenter (n=11), open-label, parallel group, controlled research study to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care. Intervention scheme/Study flow Enterostomy Creation Informed Consent Randomization Intervention vs Control group Enterostomy Closure Follow-Ups

Study Design. This is a randomized, multicenter (n=11), open-label, parallel group, controlled research study to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care. Intervention scheme/Study flow Enterostomy Creation Informed Consent Randomization Intervention vs Control group Enterostomy Closure Follow-UpsUps (3 & 6 months postoperative)

Study Design. This is a randomized, multicenter (n=11approx..=13), open-label, parallel group, controlled research study to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care. Intervention scheme/Study flow Enterostomy Creation Informed Consent Randomization Intervention vs Control group Enterostomy Closure Follow-UpsFlow