The goal of this pilot clinical trial is provide preminary evidence of the effectiveness of the C-REX device, developed by CarpoNovum AB, in preventing anastomotic leak and improving anastomosis healing after sigmoid or high rectal resection in patients with colon neoplasia. The primary aim of the study is to evaluate the rate of anastomotic leak in patients receiving the study device within 90 days from the surgical procedure.
Despite technological advancements, the rate of anastomotic leak after left colon and high rectal resection remains high, around 20%. The device C-REX, developed by CarpoNovum, may help the anastomosis construction and promote its healing. This may lead to reduced anastomotic leak rate and severity. This study aims to collect preliminary evidence on the effectiveness of C-REX to develop a future larger multicentric trial. This pilot study will collect preliminary data on the rate and severity of 90-day anastomotic leak in patients receiving the C-REX device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The C-REX device consists of an invasive surgical part, including two anastomotic rings, and surgical instruments for assisting the placement of the anastomotic ring to intestine. The rings are loosen from the inside of the intestinal wall and expelled with faeces per rectum once the anastomosis is healed in approximately ten days.
IRCCS Humanitas Research Hospital
Rozzano, MI, Italy
Anastomotic leak rate
Rate of radiologically confirmed anastomotic leaks and their severity according to the International Study Group of Rectal Cancer (ISGR) grade
Time frame: 90 days after surgery
Intraoperative anastomotic failures
Rate of intraoperative anastomotic construction failures, as confirmed by positive air leak test, reverse air leak test, or C-REX integrity pressure test after anastomosis construction
Time frame: Intraoperative
Time of anastomosis construction
Median time (in minutes) required to construct the anastomosis using the C-REX device
Time frame: Intraoperative
Time of C-REX evacuation
Median time required to evacuate the anastomotic ring of the C-REX device, in days
Time frame: Ten days after surgery
Anastomosis stenosis incidence rate
Incidence rate of anastomotic stenosis, as confirmed by digital endoscopy
Time frame: 90 days after surgery
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