A prospective multi-institutional study assessing clinical outcome with the NiTi compression anastomosis ring (Biodynamix ColonRingTM) in elective colorectal anastomoses.

BACKGROUND/AIMS: This 3-institution study assessed the short-term clinical outcome and safety profile of the NiTi Biodynamix ColonRingTM compression anastomosis in elective colorectal resection.

METHODOLOGY

A prospective, open-label, non-randomized trial was conducted at 3 separate institutions between October 2008 to October 2009 in patients undergoing elective colorectal resection with the Biodynamix ColonRingTM compression anastomosis ring, assessing technical factors in its operative use, immediate and short-term clinical outcome parameters (length of hospital stay, time to first passage of flatus and stool and to oral intake) and peri-operative complications including anastomotic failure or stenosis and wound infection.

RESULTS

Forty patients (22 females, mean age 65.9 years; range 36-83 years were included in the analysis with 14 cases being performed laparoscopically. The median duration of surgery was 120 minutes (range 60-456 minutes) with a mean anastomotic time of 14.8 minutes (range 1.75-50 minutes). The mean height of anastomosis from the anal verge was 18.2cm. The median time to passage of first flatus and first stool was 2.4 and 3.5 days, respectively with a mean hospital stay of 7.3 days. There was one postoperative death (unrelated to an anastomotic complication) with 2 anastomotic leaks (5%), 2 wound infections (5%) and no cases of early anastomotic stricture.

CONCLUSIONS

The compression anastomosis ColonRingTM handles easily with an acceptable clinical outcome following both laparoscopic and open use. The incidence of anastomotic and wound complications is comparable to conventional stapled technology.