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New study tests Stoma-Free option for rectal cancer patients

NCT ID NCT07605611

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether giving a drug called somatostatin along with a clear liquid diet for a week after rectal cancer surgery can prevent dangerous bowel leaks as well as a temporary stoma (a bag outside the body). About 72 adults with low or mid rectal cancer will be randomly assigned to one of these two approaches. The goal is to see if the drug-and-diet method can reduce the need for a stoma while keeping patients safe.

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 72 people

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

Started

Nov 2025

Expected to finish

Jun 2030

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 75 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: 1. Adults aged 18 to 75 years 2. Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center 3. The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination 4. The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge 5. Patients have two or more risk factors for anastomotic leakage as assessed by the study team 6. American Society of Anesthesiologists physical status classification is grade 3 or lower 7. Body mass index is less than 30 kg/m² 8. The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent Exclusion Criteria: 1. Has another colorectal malignant tumor at the same time 2. The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge 3. Has metastatic disease before surgery 4. Is pregnant 5. Has a mental illness or addictive disorder that would prevent participation in the clinical trial 6. Requires emergency surgery 7. Has inflammatory bowel disease 8. Is allergic to somatostatin or is unable to tolerate somatostatin 9. For participants assigned to the no-stoma group, the surgeon decides that a stoma is required 10. Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery 11. Has any other condition that makes it impossible to follow the study protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 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

  • Ezhou Central Hospital

    RECRUITING

    Ezhou, Hubei, China

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • Wuhan No. 6 Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

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