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New 'Bottom-Up' surgery could improve rectal cancer outcomes

NCT ID NCT03144765

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new surgical technique called transanal total mesorectal excision (taTME) for rectal cancer. Instead of operating from the abdomen, surgeons work from the anus upward, which may make it easier to remove the tumor completely. The trial includes 100 adults with early to mid-stage rectal cancer and will measure how well the surgery removes the cancer and how safe it is.

What this could mean

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

Active substance
Transanal total mesorectal excision (taTME) surgery
What this could lead to
If successful, this could offer a safer, more effective surgical option for rectal cancer, potentially reducing complications and improving recovery.
What could go wrong
This is a mid-stage trial with only 100 participants and no comparison group. The technique is complex and may not prove better than standard surgery. Long-term outcomes are still unknown.

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

100 people

The number who actually took part.

Started

Sep 2017

Expected to finish

Apr 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 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: * New diagnosis of histologically confirmed adenocarcinoma of the rectum * Age ≥18 * Clinical stage cT1 (high-risk), T2, or T3, cN0, N1, N2 on staging pelvic MRI * Negative predicted CRM on staging pelvic MRI * No evidence of metastasis on CT scans of the chest, abdomen and pelvis * Rectal cancer located within 10 cm from the anal verge based on proctoscopy and digital rectal examination (DRE) * Complete preoperative colonoscopy demonstrating no synchronous colon cancer * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Eligible to undergo laparoscopic or robotic LAR with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus * Able to understand and willing to sign a written informed consent form Exclusion Criteria: * cT4 on staging pelvic MRI * \>12 weeks delay between completion of neoadjuvant CRT and planned study procedure * Severely symptomatic rectal tumors * Tumors invading into the internal anal sphincter muscle based on DRE and pelvic MRI * Fecal incontinence at baseline * Prior history of rectal resection * Prior history of colorectal cancer * History of inflammatory bowel disease * Uncontrolled concurrent illness * Pregnancy * Subjects who cannot read or understand English

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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.

Contacts and locations

Locations

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Florida Hospital

    Orlando, Florida, 32804, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Kaiser Permanente

    Los Angeles, California, 90027, United States

  • Lankenau Institute

    Wynnewood, Pennsylvania, 19096, United States

  • Mount Sinai Beth Israel

    New York, New York, 10003, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Toronto Western Hospital

    Toronto, Canada

  • UC Irvine Hospital

    Orange, California, 92868, United States

  • University of Massachusetts

    Worcester, Massachusetts, 01605, United States

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