REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
Recruiting
N/A
Interventional Study
TME
Rectal Cancer Surgery
Low Rectal Cancer
Middle Rectal Cancer
Local Advanced Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 442 (estimated)
- Sponsor
- ANO Scientific and Practical Club for the Development of Modern Medical Technologies · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage.
The primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferio…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* Age \>18 years;
* Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);
* Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;
* Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and/or pelvic MRI);
* P…
Contacts