Background: The aim of this prospective study was to evaluate safety and efficacy of the NiTi ColonRing™ for anastomoses on the colon or rectum.
Methods: During the period September 2008-June 2011, anastomosis using the NiTi ColonRing™ was scheduled to be performed on 60 patients (36 females, 24 males/mean aged 67 years), 53 of whom underwent colectomy for cancer and 7 reconstruction after Hartmann's procedure. Application of the device failed in one case due to anatomical reasons. Colorectal resections performed were as follows: Right hemicolectomy (5 patients), left colectomy (2), sigmoidectomy (15) and low anterior resection (31). A follow-up clinic visit after 1 month was planned for all patients. Ten patients among the first 14 had rectosigmoidoscopy at 2-3 months. All cancer patients were scheduled for colonoscopy at 12 months.
Results: No intraoperative or postoperative bleeding related to the anastomotic technique was recorded. Median hospital stay after surgery was 10.2 days (9-22 days). One patient died on day 13 due to myocardial infarction. Clinically apparent leak was detected in one patient who had undergone reconstruction after Hartmann; the only treatment required was total parenteral nutrition for 12 days. Anastomotic stenosis occurred in another one patient who had undergone reconstruction after Hartmann; it was easily resolved by balloon dilatation. Mild complications were encountered in 23 other patients (39%). Oral feeding started after day 4. Anastomotic rings were expelled naturally within 7-17 days (mean, 9.2 days). A satisfactory anastomosis was revealed in patients examined colonoscopically at 2-3 and 12 months. Mean follow-up was 15.2 months (2-33 months).
Conclusions: NiTi ColonRing™ is reliable, safe and efficacious for large bowel anastomoses.