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Real-Time margin check during rectal cancer surgery may cut recurrence

NCT ID NCT07398716

Knowledge-focused Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether checking the removed tissue during surgery (frozen section) helps ensure all cancer is removed in people with mid or low rectal cancer who had radiation therapy. 99 patients were split into two groups: one had the extra check, the other had standard surgery. The goal was to see if the check reduces the chance of cancer coming back or needing more extensive surgery.

What this could mean

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

Active substance
Intraoperative frozen section assessment
What this could lead to
If successful, this could show that checking margins during surgery helps reduce local cancer recurrence and the need for more extensive surgery.
What could go wrong
This is a small, completed study (99 patients) without a phase designation, so results may not be definitive or widely applicable. The procedure adds time to surgery and may not improve long-term outcomes.

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

99 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 90 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: * Patients diagnosed with mid or low rectal cancer (Stage I-III) * Patients who have received short-course or long-course neoadjuvant radiotherapy * Patients evaluated and approved for surgery by a multidisciplinary oncology board * Patients scheduled for total mesorectal excision (TME) * Age ≥ 18 years * Patients who provide written informed consent Exclusion Criteria: * Stage IV rectal cancer * Upper rectal tumors * Patients undergoing emergency surgery * Patients planned for local excision or palliative surgery * Patients with distant metastasis * Patients with a history of previous rectal surgery

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

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

Rectal cancer

Contacts and locations

Locations

  • Bakırköy Dr. Sadi Konuk Training and Research Hospital

    Bakırköy, Istanbul, 34147, Turkey (Türkiye)

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