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Stoma-Free surgery for rectal cancer? new trial tests safety

NCT ID NCT07463261

Disease control Sponsor: ANO Scientific and Practical Club for the Development of Modern Medical Technologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether low-risk rectal cancer patients can safely undergo surgery without a temporary stoma (a bag attached to the belly to collect waste). The trial will compare leak rates in 442 patients who either get a stoma or not. If skipping the stoma is shown to be safe, it could mean fewer surgeries and better quality of life for many patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Preventive stoma (diverting ileostomy or transverse colostomy) versus no stoma
What this could lead to
If successful, this could show that many low-risk rectal cancer patients can safely avoid a temporary stoma, improving quality of life after surgery.
What could go wrong
This is a mid-stage trial with 442 participants, so results may not apply to all patients. There is a risk that skipping the stoma could lead to more anastomotic leaks, requiring emergency reoperation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 442 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 type 2 diabetes mellitus, or psychiatric/neurological disorders impairing the ability to provide informed consent; * Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively; * Predicted risk of anastomotic leakage \>10% (AFOR 2-6).

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Local advanced rectal cancer Low rectal cancer Middle rectal cancer Rectal cancer surgery TME

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation

    RECRUITING

    Moscow, Russia

  • Leningrad Regional Clinical Hospital

    RECRUITING

    Saint Petersburg, Russia

  • Moscow City Oncology Hospital No. 62 of the Moscow Department of Health

    RECRUITING

    Moscow, 143423, Russia

  • Republican clinical oncological center

    RECRUITING

    Ufa, Russia

  • State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary""

    RECRUITING

    Nizhny Novgorod, Russia

  • 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"

    RECRUITING

    Moscow, Russia

  • Sverdlovsk Regional Oncological Center

    RECRUITING

    Yekaterinburg, Russia

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