Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Main objective is to evaluate effectiveness of delayed coloanal anastomosis (ACAD) in the medium and lower rectal cancer treatment,
The primary endpoint was the effectiveness of the ACAD surgery evaluated in terms of absence of fistula requiring stoma diversion. We wish to highlight that the rate of patients with a fistula requiring stoma diversion is less than 15%, that is to say that the effectiveness of the ACAD rate is higher than 85%. Based on a one-sided binomial test with the null and alternative hypotheses respectively 85% 95% 53 ACAD eligible and evaluable patients will be required (one-sided type I error of 5% and 80% power). If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the ACAD is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients ACAD.
Delayed coloanal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation
EVRARD Serge, PU-PH
FRANCE : French Agency for Sanitary Safety of Health Products