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New treatment option for TME
Official title REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
ClinicalTrials.gov ID: NCT07463261
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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);
- Planned radical minimally invasive (laparoscopic/robot-assisted) intervention with TME and formation of primary colorectal/colonanal anastomosis;
You likely can't join if
- Age ≥80 years;
- Presence of a pre-existing diverting ileostomy or colostomy;
- Peritumoral abscess or tumor perforation;
- Distant metastases (M1) identified preoperatively and/or intraoperatively;
- Synchronous or metachronous malignancy;
- Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);
See the full 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);
- Planned radical minimally invasive (laparoscopic/robot-assisted) intervention with TME and formation of primary colorectal/colonanal anastomosis;
- Adequate hematologic function: hemoglobin ≥100 g/L, leukocytes \>4 × 10\^9/L, platelets \>100 × 10\^9/L;
- Adequate renal function: serum creatinine \<150 µmol/L;
- Adequate hepatic function: AST/ALT \<100 U/L;
- Predicted risk of anastomotic leakage ≤10% (AFOR 0-1).
- Age ≥80 years;
- Presence of a pre-existing diverting ileostomy or colostomy;
- Peritumoral abscess or tumor perforation;
- Distant metastases (M1) identified preoperatively and/or intraoperatively;
- Synchronous or metachronous malignancy;
- Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);
- Evidence of malnutrition (serum albumin \<34 g/L);
- Severe uncontrolled comorbid conditions (e.g., acute myocardial infarction, uncontrolled hypertension, decompensated heart failure, immunosuppression, systemic corticosteroid therapy, severe chronic obstructive...
- Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively;
- Predicted risk of anastomotic leakage \>10% (AFOR 2-6).
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
- Nizhny Novgorod, Russia
- Saint Petersburg, Russia
- Ufa, Russia
- Yekaterinburg, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia; Nizhny Novgorod, Russia; Saint Petersburg, Russia; Ufa, Russia; Yekaterinburg, Russia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.