New study tests Stoma-Free option for rectal cancer patients
NCT ID NCT07605611
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving a drug called somatostatin along with a clear liquid diet for a week after rectal cancer surgery can prevent dangerous bowel leaks as well as a temporary stoma (a bag outside the body). About 72 adults with low or mid rectal cancer will be randomly assigned to one of these two approaches. The goal is to see if the drug-and-diet method can reduce the need for a stoma while keeping patients safe.
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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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2030
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. Adults aged 18 to 75 years 2. Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center 3. The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination 4. The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge 5. Patients have two or more risk factors for anastomotic leakage as assessed by the study team 6. American Society of Anesthesiologists physical status classification is grade 3 or lower 7. Body mass index is less than 30 kg/m² 8. The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent Exclusion Criteria: 1. Has another colorectal malignant tumor at the same time 2. The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge 3. Has metastatic disease before surgery 4. Is pregnant 5. Has a mental illness or addictive disorder that would prevent participation in the clinical trial 6. Requires emergency surgery 7. Has inflammatory bowel disease 8. Is allergic to somatostatin or is unable to tolerate somatostatin 9. For participants assigned to the no-stoma group, the surgeon decides that a stoma is required 10. Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery 11. Has any other condition that makes it impossible to follow the study protocol
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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
3 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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Ezhou Central Hospital
RECRUITINGEzhou, Hubei, China
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, China
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Wuhan No. 6 Hospital
NOT_YET_RECRUITINGWuhan, Hubei, China
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Other studies related to the condition(s) this trial covers.
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- Laser light may help surgeons spot risky bowel connections