End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study (NCT00497263) | Clinical Trial Compass
CompletedPhase 2
End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study
Belgium
Plain-language summary
the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient age over 18
* Patient schedule for colonic surgery requiring E-t-E anastomosis
* Patient is able to understand and to sign the Informed Consent Form
Exclusion Criteria:
* Patient has known allergy to Nickel
* Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection
* Patient on regular steroid medication
* Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis
* Patient following radiation (that compromised the anastomosis)
* Patient who are undergoing a defunctioning stoma
* Patient with contraindication to general anesthesia
* Patient who is currently participating in other clinical trial
* Patient who refuse consent
What they're measuring
1
functioning anastomosis & no occurrence of adverse events related to device use
Timeframe: during hospitalization and until 3 months after discharge