New surgery may help rectal cancer patients avoid permanent stoma
NCT ID NCT07369531
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special delayed-connection surgery (Turnbull-Cutait) can help people with low rectal cancer avoid a permanent colostomy bag better than the standard surgery with a temporary stoma. About 520 adults aged 18-75 with rectal cancer will be randomly assigned to one of the two surgeries. Researchers will track who remains stoma-free and alive after 3 years, and also compare bowel function, quality of life, and complications.
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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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About 520 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2031
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 to 75 years
- 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: 1. Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma; 2. Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis; 3. Preoperative rectal MRI evaluation demonstrated that the tumor was located within 5cm below the anal margin, above the intermuscular groove between the internal and external anal sphincters (anal white line) by 1 cm, and without invasion of the external anal sphincter; 4. For tumors located above the levator ani hiatus, MRI evaluation showed cT1-3, cN0-1, M0, MRF (-); for tumors located below the levator ani hiatus, MRI evaluation showed cT1-2, cN0-1, M0, MRF (-). For patients who received neoadjuvant therapy, tumors above the levator ani hiatus were downstaged to ycT3NxM0 or below, and tumors below the levator ani hiatus were downstaged to ycT2NxM0 or below; 5. Preoperative BMI \< 28 kg/m² 6. Patients underwent radical laparoscopic/robot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME). Exclusion Criteria: 1. Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers; 2. History of previous open surgery (non-minimally invasive procedures); 3. Failure to undergo preoperative rectal MRI evaluation and chest/abdominal imaging assessment, resulting in incomplete clinical staging of the tumor; 4. Pregnant patients or those with concurrent inflammatory bowel disease; 5. Preoperative patients with complete intestinal obstruction or requiring emergency surgery; 6. Preoperative anticipated multivisceral resection or intraoperative required combined organ resection is indicated.; 7. Recent treatment for other malignancies; 8. Low rectal cancer classified as type IV in the Bordeaux classification system; 9. Intraoperatively confirmed distant metastatic disease 10. Preoperative pathological types of signet ring cell carcinoma, mucinous adenocarcinoma, anaplastic carcinoma, or poorly differentiated carcinoma. Withdrawal Criteria 1. Patients who refuse surgical intervention after randomization. 2. Patients who undergo an abdominoperineal resection (APR) following randomization. 3. Patients who request voluntary withdrawal from the trial at any time throughout the study period.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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First Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130012, China
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First Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130021, China
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