REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department

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-inferior to that in the diverting stoma group. The secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30,

Trial Details

NCT ID
NCT07463261
Phase
NA
Sponsor
ANO Scientific and Practical Club for the Development of Modern Medical Technologies
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Without a preventive stoma
  • With a preventive stoma
Locations (sample)
  • Moscow, Russia|55.75204,37.61781
  • Moscow, Russia|55.75204,37.61781
  • Moscow, Russia|55.75204,37.61781
  • Nizhny Novgorod, Russia|56.32867,44.00205
  • Saint Petersburg, Russia|59.93863,30.31413

Key Eligibility 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);

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →