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Can a smarter drainage tube stop a deadly leak after rectal cancer surgery?

NCT ID NCT07036588

Disease control Sponsor: Third Military Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether a modified transanal drainage tube can prevent anastomotic leakage—a serious complication where the new connection in the bowel leaks—after surgery for rectal cancer. About 968 adults with rectal adenocarcinoma will receive either the modified tube or standard care following their surgery. The study will compare the rate of leakage within 30 days after surgery, as well as the severity of any leaks and other complications.

What this could mean

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

Active substance
A modified transanal drainage tube (a balloon-tipped catheter placed during surgery to drain gas and feces and protect the new connection in the bowel)
What this could lead to
If effective, this simple device could reduce the risk of anastomotic leakage after rectal cancer surgery, potentially lowering complications, hospital stays, and the need for repeat operations.
What could go wrong
The trial is still testing the device, and it may not prove better than standard care. There are also risks of discomfort, infection, or injury from the tube itself.

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 968 people

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

Started

Jul 2025

Expected to finish

Dec 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 80 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: * Rectal adenocarcinoma (confirmed by pathology); * Tumor location: The lower edge is ≤10 cm from the anal verge; * Age: ≥18 and ≤80 years old; * ASA ≤3 ; * After assessment, laparoscopic/robotic sphincter - preserving surgery for rectal cancer is feasible; * T2 - 4N0 - 2M0\~T0 - 1N1 - 2M0 \& non- local recurrence; * Signed informed consent form; * Able to understand the risks of participating in the trial. Exclusion Criteria: * Emergency surgery; * Presence of multiple primary colorectal cancers; * History of long - term use of immunosuppressants or corticosteroids; * Patients with severe mental illness or uncontrolled infection before surgery; * Pregnant or breastfeeding women; * Bowel obstruction before surgery； * BMI ≥35.0

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak rectum adenocarcinoma

As listed by the trial registrant

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

Anastomotic leak

How to take part

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

  1. The places running it

    1 site. 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

  • Army Medical Center (Daping Hospital)

    RECRUITING

    Yuzhong, Chongqing Municipality, 400042, China

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