nitinol and Anastomotic-Leak

Preclinical studies have suggested that nitinol-based compression anastomosis might be a viable solution to anastomotic leak following low anterior resection. A prospective multicentre open label study was therefore designed to evaluate the performance of the ColonRing(™) in (low) colorectal anastomosis.. The primary outcome measure was anastomotic leakage. Patients were recruited at 13 different colorectal surgical units in Europe, the United States and Israel. Institutional review board approval was obtained.. Between 21 March 2010 and 3 August 2011, 266 patients completed the study protocol. The overall anastomotic leakage rate was 5.3% for all anastomoses, including a rate of 3.1% for low anastomoses. Septic anastomotic complications occurred in 8.3% of all anastomoses and 8.2% of low anastomoses.. Nitinol compression anastomosis is safe, effective and easy to use and may offer an advantage for low colorectal anastomosis. A prospective randomized trial comparing ColonRing(™) with conventional stapling is needed.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Anastomosis, Surgical; Anastomotic Leak; Colectomy; Colon; Europe; Female; Humans; Israel; Male; Middle Aged; Product Surveillance, Postmarketing; Prospective Studies; Rectum; Sepsis; United States; Young Adult

The NiTi CAR™ 27 is a newer device that uses compression to create an anastomosis. An analysis of this device in the creation of colorectal anastomoses in humans has yet to be reported in the USA.. A non-randomized, prospective pilot study of the NiTi CAR™ 27 device in patients undergoing a left-sided colectomy between March 2008 and August 2009 was performed.. Twenty-three patients (9 men and 14 women) underwent a left-sided colectomy and compression anastomosis with the CAR™ 27 device. Minor morbidities, 3 of 23 (13%) patients, included one small postoperative abscess requiring antibiotics alone and two postoperative anastomotic strictures requiring balloon dilation. Major morbidities, 1 of 23 (4%) patients, included a partial anastomotic dehiscence/leak requiring surgical dismantling of the anastomosis and diversion.. The CAR™ 27 device shows promise as a safe and effective alternative for the creation of colorectal anastomoses. However, studies in a larger patient population are warranted to demonstrate equivalence of this device.

Topics: Adult; Aged; Alloys; Anastomosis, Surgical; Anastomotic Leak; Colon; Female; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Rectum

This study aimed to evaluate the safety and efficacy of a new nickel-titanium shape memory alloy compression anastomosis ring, NiTi CAR 27, in constructing an anastomosis for colorectal cancer resection compared with conventional staples.. In total, 234 consecutive patients diagnosed with colorectal cancer receiving sigmoidectomy and anterior resection for end-to-end anastomosis from May 2010 to June 2012 were retrospectively analyzed. The postoperative clinical parameters, postoperative complications and 3-year overall survival in 77 patients using a NiTi CAR 27 compression ring (CAR group) and 157 patients with conventional circular staplers (STA group) were compared.. There were no statistically significant differences between the patients in the two groups in terms of general demographics and tumor features. A clinically apparent anastomotic leak occurred in 2 patients (2.6%) in the CAR group and in 5 patients (3.2%) in the STA group (p=0.804). These eight patients received a temporary diverting ileostomy. One patient (1.3%) in the CAR group was diagnosed with anastomotic stricture through an electronic colonoscopy after 3 months postoperatively. The incidence of postoperative intestinal obstruction was comparable between the two groups (p=0.192). With a median follow-up duration of 39.6 months, the 3-year overall survival rate was 83.1% in the CAR group and 89.0% in the STA group (p=0.152).. NiTi CAR 27 is safe and effective for colorectal end-to-end anastomosis. Its use is equivalent to that of the conventional circular staplers. This study suggests that NiTi CAR 27 may be a beneficial alternative in colorectal anastomosis in Chinese colorectal cancer patients.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Anastomosis, Surgical; Anastomotic Leak; Colon, Sigmoid; Colorectal Neoplasms; Equipment Design; Equipment Safety; Female; Humans; Male; Middle Aged; Postoperative Period; Retrospective Studies; Surgical Staplers; Treatment Outcome; Young Adult

With increasingly advanced therapeutic endoscopic procedures and more complex gastrointestinal surgery, endoscopists are more often confronted with perforations, fistulas, and anastomotic leakages for which nonsurgical closure is desired. The over-the-scope clip (OTSC) is a novel endoscopic tool for consideration in such situations. We treated seven patients (age range 35 - 83 years; five men, two women), three with colonic perforation, one with perforation of the stomach, and three with anastomotic leakage after gastrointestinal surgery. Follow-up was at least 74 days. Eight OTSCs were deployed. In all but one patient closure of the perforation was demonstrated. Further surgery was avoided in four of the seven patients. The OTSC is a system that is easy to handle and safe. It seems to be ideally suited to use for a relatively small (iatrogenic) perforation, where a single clip can be released with carbon dioxide insufflation. Anastomosis leakage and larger dehiscence can also be treated to avoid further surgery, but the utility in this situation needs to be defined in the future.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Anastomotic Leak; Colon; Endoscopy, Gastrointestinal; Female; Humans; Intestinal Perforation; Male; Middle Aged; Surgical Instruments