• Parameters measured during the patient's hospitalization such as hospitalization time, time to flatus, time to bowel movements, time to toleration of liquids and fluids, use of narcotics and analgesics etc. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Quality of life measurements [ Time Frame: pre-op to 30 days ] [ Designated as safety issue: No ]

The purpose of this research is to try to find out if a device called a Compression Anastomosis Ring (CAR™ 27) will make it easier for surgeons to reconnect the two ends of the intestine and reduce the risk of complications as part of an end-to-end anastomosis.

NiTi Surgical Solutions, Ltd is investigating a new device which compresses or pinches the two ends of the intestines together until natural scar tissue forms along the circumference of the reconnection site to heal it. The CAR™ 27 device is very similar to the stapling devices routinely used, and has been approved by the Food and Drug Administration (FDA) for the use of joining two ends of the intestine in humans in the United States.

Over the past several years, the unique characteristics of super elasticity, shape-memory, acceptable resistance to corrosion, and biocompatibility exhibited by titanium-nickel memory alloys have been exploited in the manufacture of biomedical devices. Shape memory and super elastic implants have recently aroused wide interest in the medical field, and a number of proposed applications have been discussed in many articles.

One of these new fields involves the use of new surgical devices for the creation of anastomoses in the alimentary tract. Previous attempts at compression anastomoses have included the Murphy button, biofragmentable anastomotic ring (BAR) and AKA-2 devices. These have suffered to variable extents from difficulties in construction of the anastomosis to painful extraction per rectum.

The study outlined in this protocol assesses the technical feasibility and clinical performance of a device which uses shape memory metal in the Compression Anastomosis Ring (CAR™ 27). The CAR™ 27 has parts made of nickel-titanium alloy and is used in the creation of gastrointestinal anastomoses.

The nitinol in the ring (which contains nickel) is only in the springs and therefore is not in direct contact with the tissue that heals around the ring.

Currently, colorectal anastomoses are created either with stapling devices or by a hand-sewn technique. These techniques do not provide a completely "sealed" reconnection until the body's healing process "plugs" the defects. A colorectal anastomosis can develop serious complications such as anastomotic leaks or strictures. After anterior resection, the incidence of anastomotic leak ranges from 2.9% to 15.3% and the incidence of subsequent stenosis or stricture ranges from 1.2% to 4.2%. While some leaks and strictures are clinically silent, others require surgical intervention and can lead to significant morbidity and mortality. As a result the idea of tissue compression has been revisited.

Preliminary human data regarding the use of nitinol compression technology to construct colorectal anastomoses with the CAR suggests a safe, equivalent anastomosis to that produced by stapled anastomosis. This protocol is designed to develop data in regards to compression anastomosis in colon and colorectal procedures.

All surgeons will be trained by the company in an inanimate lab on the use of the device. The procedure is extremely similar to using a circular stapler and therefore the technical learning curve is very short. In addition the company's staff will be present during the first procedures to answer any questions or concerns. The company's staff will continue to join the procedures until the surgeons feels confident to continue without this support.

The CAR™ 27 device is similar to a regular circular stapler. The anvil of the device contains a durable plastic ring on the proximal side. The plastic ring is designed to hold tissue firmly in place once joined to the base. The base of the device contains a ring that has shape-memory Nickel-titanium alloy springs inside. When the device is "fired" it holds the two ends of tissue together with circumferentially placed barbed points which penetrate from the metal ring through the tissue, holding it to the plastic ring. The ring is released when the device is fired, creating a uniform compression around the ring. The device has a circular blade which cuts the tissue within the ring, creating a patent anastomosis. The tissue heals around the circular edges that are held within the ring and the device along with the compressed tissue slough off over the following days, at which point the ring is expelled from the body with a later bowel movement. The CAR™ 27 does not leave any foreign material in the body, creating a more natural union of tissue. The CAR™ 27 device has been cleared by the FDA and has obtained a CE mark.

The objective of this study is to evaluate the ability of the CAR™ 27 to create a colorectal compression anastomoses in patients, without device related adverse events and to evaluate the outcomes of the CAR™ 27 anastomoses in relation to complications during and post procedure.

• Inflammatory Bowel Diseases
• Peritonitis
• Colorectal Surgery

Inclusion Criteria:

• Patient is over 18 years old.
• Scheduled for a non-emergency procedure.
• Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

• Patient has an allergy to nickel.
• Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
• Patient is participating in another clinical trial which may affect this study's outcomes.
• Patient has been taking regular steroid medication.
• Patient has contraindications to general anesthesia.
• Patient has pre-existing sphincter problems or evidence of extensive local disease in the pelvis.