A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection
- Conditions
- Colorectal Neoplasms
- Interventions
- Device: C-REX
- Registration Number
- NCT06481605
- Lead Sponsor
- Istituto Clinico Humanitas
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description C-REX C-REX Patients will receive the C-REX device during anastomosis construction
- Primary Outcome Measures
Name Time Method Radiological anastomotic leaks 90 days after surgery Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm
- Secondary Outcome Measures
Name Time Method 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
Time of anastomosis construction Intraoperative Assess the median time of anastomosis construction in the C-REX arm
Postoperative complications 90 days after surgery Assess the median Comprehensive Complication Index (CCI) 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
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.
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
Helathcare costs 90 days after surgery Evaluate the median healthcare costs (direct and indirect) 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).
Positive leak tests Intraoperative Assess the rate of intraoperative positive leak tests in the C-REX arm
Trial Locations
- Locations (1)
IRCCS Humanitas Research Hospital
🇮🇹Rozzano, MI, Italy