Colorectal Neoplasms
Conditions
Keywords
Colorectal Neoplasm, Anastomosis, Surgical device
Brief summary
The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting.
Detailed description
Despite technological advancements, the rate of anastomotic leak after left colon and rectal resection remains high. In most cases, these complications are identified only from the clinical symptoms and the delay in the diagnosis may lead to more severe outcomes. The device C-REX, developed by CarpoNovum, may help the anastomosis construction, providing at the same time a system to monitor the anastomosis until complete 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. The objective of the study is to provide preliminary data to determine whether the C-REX device may reduce the rate and severity of anastomotic leak after left colon and high rectal resection, providing new insights on the feasibility and effectiveness of the C-REX device in a real-word setting.
Interventions
DEVICEC-REX
The C-REX is a CE-marked class IIa device consisting of an invasive surgical part, including two anastomotic rings, intended for short-term use, and surgical instruments LapAid and RectoAid for assisting the placement of the anastomotic ring to intestine. The device is supplemented with a catheter to monitor the anastomosis.
Sponsors
Carponovum AB
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pilot, single-center, interventional, prospective case-series study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old, men or women. * Planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice. * Patient indicated to elective minimally invasive sigmoid or high rectal resection.
Exclusion criteria
* Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. * Patients with preoperative evidence of distal metastasis. * Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. * Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition. * Patients indicated to defunctioning ileostomy (intention to treat). * Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological anastomotic leaks | 90 days after surgery | Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive leak tests | Intraoperative | Assess the rate of intraoperative positive leak tests in the C-REX arm |
| Positive C-REX integrity tests | Intraoperative | Assess the rate of intraoperative positive C-REX integrity tests in the C-REX arm |
| Time of anastomosis construction | Intraoperative | Assess the median time of anastomosis construction in the C-REX arm |
| Anastomotic stenosis | 90 days after surgery | Assess the rate of anastomosis stenosis, as assessed by the 90-day endoscopic evaluation in the C-REX arm |
| Severity of anastomotic leaks | 90 days after surgery | Assess the severity of the anastomotic leaks, classifying the events according to the International Study Group of Rectal Cancer (ISGR) criteria in the C-REX arm |
| Helathcare costs | 90 days after surgery | Evaluate the median healthcare costs (direct and indirect) in the C-REX arm |
| Low Anterior Resection Syndrome | 90 days after surgery | Assess the median Low Anterior Resection Syndrome (LARS) score (ranging from 0 to 40, with 21 indicating significant symtpoms) in the C-REX arm. |
| Investigator's satisfaction | Intraoperative | Evaluate the grade of investigator's satisfaction in using the C-REX device by using a simple likert scale ranging from 0 (completely unsatisfaid) to 5 (completely satisfaid). |
| Postoperative complications | 90 days after surgery | Assess the median Comprehensive Complication Index (CCI) in the C-REX arm |
Countries
Italy
Contacts
Primary ContactAnnalisa Spinelli, PhD
Backup ContactStefano De Zanet, MS
Outcome results
None listed