Traditional lateral ileostomy versus percutaneous ileostomy by exclusion probe for the protection of extraperitoneal colo-rectal anastomosis: the ALPPI (Anastomotic Leak Prevention by Probe Ileostomy) trial. A randomized controlled trial.

BACKGROUND:Low colo-rectal anastomoses have a relevant risk of leakage. The protective stomas (ileostomy or colostomy) have always been utilized to reduce the complications due to anastomotic leakage. The stoma not only causes relevant morbidity but also needs a second operation to be closed, with an added risk of complications. PURPOSE:For this reason we planed and carried out a temporary percutaneous ileostomy by a jejunal probe introduced in the distal ileum, that can be removed without a surgical procedure and with negligible complications. METHODS:The ALPPI trial is a randomized controlled, open, parallel, equivalence multicenter study. Patients undergoing elective laparoscopic or laparotomic surgery for rectal cancer with extraperitoneal anastomosis, will be randomly allocated to undergo either lateral ileostomy or percutaneous ileostomy by exclusion probe. RESULTS:The primary endpoint is the protection of the extraperitoneal colo-rectal anastomosis in terms of incidence of symptomatic and asymptomatic anastomotic leakages. The secondary endpoints are the evaluation of complications due to the placement and the removal of the exclusion probe for percutaneous ileostomy. CONCLUSIONS:The ALPPI trial is designed to provide the surgical community with an evidence based new technique in the protection of low colo-rectal anastomosis, alternative to the conventional stomas. TRIAL REGISTRATION:The ALPPI trial was approved by the Ethical Committee of Regional Public Health System of Umbria, Italy, (Protocol Number 28657/11/AV, study code RO-MA 01) and it is registered in the International Standard Randomised Controlled Trial Number (ISRCTN) Register with identification number ISRCTN99356919.