Pressure-controlled tube ileostomy after lower anterior resection of rectal cancer: a new type of protective stoma in rectal anastomosis.

Abstract

Background: Tube ileostomy can prevent anastomotic leakage (AL) on the patients underwent lower anterior resection. However, it has one major disadvantage: the inability to control fecal diversion efficacy (FDE). In this single-center, prospective randomized controlled trial (RCT), we evaluated a novel technique, pressure-controlled tube ileostomy (PCTI), which uses cuff-pressure adjustment to maintain reliable FDE, and assessed its safety and effectiveness.

Methods: This study was conducted as a single-center prospective RCT. Patients were randomly allocated (1:1) to PCTI or LI (Ll) using a computer-generated sequence with allocation concealment via sealed opaque envelopes; blinding of surgeons/patients was not feasible.

Results: Baseline characteristics were comparable between groups. The anastomotic leakage rates were 9.2% (23/250) in the PCTI group and 9.7% (24/248) in the LI group received the initial surgery (P=0.85). The rates of stoma-related complications including infections, irritant dermatitis, herniation and so on, were 8.8% in PCTI group and 16.2% in LI group (P=0.0133), respectively. Fifteen patients received LI retained their stoma, compared with 2 in the PCTI group (P=0.0013). In PCTI group, the time of cannula extubation and stoma closure after cannula extubation were 20.5±4.6 and 7.2±4.4 days, respectively.

Conclusions: The PCTI can effectively inhibit the occurrence of grade C anastomotic leakage and reduce the occurrence of serious complications caused by anastomotic leakage through the FDE control by adjusting the cuff pressure and can avoid secondary reversal surgery. We consider that the improved PCTI is a safe and practical-surgical technique in protecting the anastomosis.