Condition: TME · Rectal Cancer Surgery · Low Rectal Cancer · Sponsor: ANO Scientific and Practical Club for the Development of Modern Medical Technologies
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, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year. Participants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage \<10% according to the study risk model.
This description comes directly from the study's public registry record.
Vladislava S Goncharova, Ms. · +7 900 468 9026 · vladislava.26@mail.ru
Nikita N Burlov, Dr. · +79819430019 · dikefsound@gmail.com
Always discuss trial participation with your own doctor first.
| Moscow City Oncology Hospital No. 62 of the Moscow Department of Health | Moscow, Russia | Recruiting |
| Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation | Moscow, Russia | Recruiting |
| State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow" | Moscow, Russia | Recruiting |
| State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary"" | Nizhny Novgorod, Russia | Recruiting |
| Leningrad Regional Clinical Hospital | Saint Petersburg, Russia | Recruiting |
| Republican clinical oncological center | Ufa, Russia | Recruiting |
| Sverdlovsk Regional Oncological Center | Yekaterinburg, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07463261