Early closure of the protective ileostomy after rectal resection should become part of the Enhanced Recovery After Surgery (ERAS) protocol: a randomized, prospective, two-center clinical trial

Introduction
Protective loop ileostomy (PLI) is used to reduce the anastomotic leak rate after resection of the rectum. It is an effective, yet burdensome procedure contradicting the aims of enhanced recovery after surgery (ERAS) by slowing down recovery. Early closure (EC) of the PLI has the potential to change the situation, and it should become part of ERAS.

Aim
To analyze the effectiveness of EC in ERAS patients.

Material and methods
A randomized clinical trial was performed between October the 1st, 2016 and December the 31st, 2017. Fifty-eight adult patients (24 females, 34 males, mean age: 55.7 and 56.2) operated on for rectal carcinoma according to the ERAS protocol with PLI were randomly assigned to the late (L) or early (E) closure group (14 days after discharge). Time to start adjuvant chemotherapy, complication rate, and health care costs were analyzed.

Results
There were no significant differences between groups regarding the length of surgery (83.2 ±15.9 vs. 87.1 ±21.7 min, in E and L, respectively), intraoperative blood loss (15.2 ±7.5 vs. 17.3 ±11.1 ml, respectively), median hospital stay, or the time to pass flatus and stool. The difference in the time needed to start the adjuvant treatment (38.7 ±5.7 vs. 33.2 ±5.8 days, p < 0.01), was compensated by the reduction of time living with a stoma (17.2 vs. 299.0 days) and health care costs: (43.68 vs. 698.42 USD).

Conclusions
Early closure is a safe and effective therapeutic approach, improving the recovery. Therefore it should be implemented as part of the ERAS protocol for rectal cancer patients.