Recruiting nowNot phasedRandomised
| Registry number | NCT07463261 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 442 people (planned) |
| Who can join | aged 18 Years to 70 Years |
| Run by | ANO Scientific and Practical Club for the Development of Modern Medical Technologies |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Without a preventive stoma
- Procedure With a preventive stoma
What it is measuring
Colorectal anastomotic leak
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers are testing whether carefully selected patients with mid- or low-rectal cancer can have a low anterior resection without a temporary diverting stoma (an opening that diverts stool away from the bowel join) without causing more anastomotic leaks, or breaks at that join, than surgery with a stoma. This is a comparison of surgical approaches, not a new drug.
A no-stoma approach could spare patients the effects of a temporary stoma and a later reversal operation if it is no less safe. The trial will mainly measure whether leakage within 30 days is no higher without a stoma, and will also compare stoma rates, quality of life, hospital recovery, complications and reoperations up to one year.
Worth knowing: The findings will apply only to patients judged to have a predicted leak risk below 10%, not to all patients undergoing rectal surgery.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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);
- 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).
Exclusion Criteria
- 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 pulmonary disease, chronic kidney disease stage 4-5), type 1 or t…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 7 sites. Listed in: Russia.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07463261, registered by ANO Scientific and Practical Club for the Development of Modern Medical Technologies on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.