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New drain technique aims to reduce complications after rectal cancer surgery

NCT ID NCT07241143

Disease control Sponsor: Yeungnam University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new drain fixation method (extra-peritoneal tunneling) to the standard method after rectal cancer surgery. About 596 participants will be randomly assigned to one of the two groups. The goal is to see if the new method reduces drain movement and improves the management of leaks without increasing complications.

What this could mean

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

Active substance
Extra-peritoneal tunneling drain fixation procedure
What this could lead to
If successful, this technique could reduce drain displacement and improve management of leaks after rectal cancer surgery, leading to fewer reoperations.
What could go wrong
This is a phase 2 trial, so results are preliminary. The new method may not be safer or more effective than the standard approach, and could have unforeseen complications.

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 596 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Feb 2029

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

20 years and older

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: * Patients scheduled to undergo rectal resection (anterior resection or low anterior resection) with planned intraoperative drain placement. * Expected anastomotic level ≤10 cm from the anal verge based on preoperative imaging or endoscopic evaluation. Exclusion Criteria: * Patients scheduled to undergo additional colonic resection (e.g., right hemicolectomy, transverse colectomy). * Patients in whom no intraoperative drain placement is planned. * Patients scheduled for permanent or end stoma formation (e.g., abdominoperineal resection or Hartmann's procedure). * Patients with prior pelvic surgery (e.g., hysterectomy, prostatectomy, pelvic lymph node dissection) that may cause pelvic adhesions or anatomic distortion. * Patients with ASA physical status IV or severe systemic disease expected to require postoperative intensive care unit (ICU) admission. * Patients who decline to provide informed consent for study participation

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal disorder rectal neoplasm sigmoid disease sigmoid neoplasm

As listed by the trial registrant

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

Rectal cancer, sigmoid colon cancer Rectal diseases, sigmoid colon disease

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

  • Sung Il Kang

    Daegu, South Korea

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