A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection (NCT06481605) | Clinical Trial Compass
UnknownNot Applicable
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection
Italy30 participantsStarted 2024-07-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.