New 'Bottom-Up' surgery could improve rectal cancer outcomes
NCT ID NCT03144765
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
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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
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100 people
The number who actually took part.
- Started
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Sep 2017
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Cleveland Clinic Florida
Weston, Florida, 33331, United States
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Florida Hospital
Orlando, Florida, 32804, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Kaiser Permanente
Los Angeles, California, 90027, United States
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Lankenau Institute
Wynnewood, Pennsylvania, 19096, United States
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Mount Sinai Beth Israel
New York, New York, 10003, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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Toronto Western Hospital
Toronto, Canada
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UC Irvine Hospital
Orange, California, 92868, United States
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University of Massachusetts
Worcester, Massachusetts, 01605, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ultrasound peers into Children's stomachs after Pre-Surgery drink
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?