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Completed
NCT02756273
Impact of a Bridge Device on the Loop Ileostomy
Conditions: Elective Colorectal Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 166
Sponsor: Centre Hospitalier Universitaire, Amiens
Location: Chu Rouen Rouen France
Summary
During the creation of an ileostomy, a bridge device is systematically placed in an aim to reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to justify this issue.
Moreover the placement of a bridge device increases the difficulty of nurse cares and is associated with its own morbidity.
Eligibility Criteria
Inclusion Criteria:
* colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease)
* requiring elective surgery with an ileostomy
* patient having given his consent before the enrollment
Exclusion Criteria:
* patient with early closure of the stoma (within 10 days after the colorectal surgery)
* long term corticoids
* emergency surgery
* history of stoma in the side of the stoma placement planned for the study
* BMI \>50
* No signature of the consent to participate in the study
* Physical or mental state not allowing participation in the study
* Contraindication to surgery
* ASA classification (American Society of Anesthesiologists) IV-V or life expectancy \
Source: ClinicalTrials.gov (NCT02756273). StuddyBuddy aggregates publicly available trial information.