Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06615583 (NOVA) for Colon Neoplasm is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection (NOVA) 30 Adaptive Design Novel Treatment
Clinical Trial NCT06615583 (NOVA) is an interventional study for Colon Neoplasm and is currently not yet recruiting. Enrollment is planned to begin on October 1, 2024 and continue until the study accrues 30 participants. Led by Istituto Clinico Humanitas, this study is expected to complete by March 31, 2026. The latest data from ClinicalTrials.gov was last updated on September 26, 2024.
Brief Summary
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...Show More
Detailed Description
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 t...Show More
Official Title
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study
Conditions
Colon NeoplasmOther Study IDs
- NOVA
- CHR1-2024-102
NCT ID Number
Start Date (Actual)
2024-10-01
Last Update Posted
2024-09-26
Completion Date (Estimated)
2026-03-31
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Colorectal neoplasms
Colorectal anastomosis
Anastomotic leak
Surgical device
Colorectal anastomosis
Anastomotic leak
Surgical device
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalC-REX arm Patients will receive the C-REX device during sigmoid or high rectal resection. They will be instructed to follow a low residue diet and administered with a stool softener for five days after the surgical intervention. Approximately ten days after surgery, patients will release the study device and the anastomosis will be assessed with digital endoscopy. | Surgical device 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Anastomotic leak rate | Rate of radiologically confirmed anastomotic leaks and their severity according to the International Study Group of Rectal Cancer (ISGR) grade | 90 days after surgery |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | Intraoperative |
Time of anastomosis construction | Median time (in minutes) required to construct the anastomosis using the C-REX device | Intraoperative |
Time of C-REX evacuation | Median time required to evacuate the anastomotic ring of the C-REX device, in days | Ten days after surgery |
Anastomosis stenosis incidence rate | Incidence rate of anastomotic stenosis, as confirmed by digital endoscopy | 90 days after surgery |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Patients aged equal or more than 18 years old, both men and women.
- Patients with a proven diagnosis of sigmoid colon or high rectal tumors requiring anterior rectal resection as procedure of choice (colorectal cancer or benign polyps), as confirmed by radiological and histological exams.
- Patient indicated to minimally invasive or open 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 intraoperative evidence of any of these conditions will be withdrawn from the study.
- Patients with preoperative evidence of distal metastasis. Patients with intraoperative evidence of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
- Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. Patients with intraoperative evidence of intestinal or anal stenosis will be withdrawn from the study.
- Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.
- Patients who are unable or received contraindication for the preoperative mechanical preparation. Patients with a preoperative evidence or suspicion of incomplete colon cleansing will be withdrawn from the study.
- Patients indicated to defunctioning stoma. Patients requiring diverting stoma as for intraoperative indication will be withdrawn from the study.
- Patients with an anastomosis in rectum below the peritoneal reflection and/or another procedure of choice than high anterior resection.
- 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.
Istituto Clinico HumanitasCarponovum ABStudy Central Contact
Contact: Annalisa Maroli, Ph.D., 02 8224 7776, [email protected]
Contact: Stefano De Zanet, 02 8224 4623, [email protected]
1 Study Locations in 1 Countries
MI
IRCCS Humanitas Research Hospital, Rozzano, MI, 20089, Italy