Leak check during bowel surgery may prevent serious complications
NCT ID NCT06865638
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether testing the surgical connection (anastomosis) for leaks right after colorectal cancer surgery can reduce complications like leakage, bleeding, or infection. About 264 patients will be randomly assigned to receive leak testing or not. The goal is to see if this simple check during surgery improves outcomes within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intraoperative leak testing (using gastroscopy, air, and methylene blue)
- What this could lead to
- If successful, this could show that routine leak testing during colorectal cancer surgery reduces serious complications like anastomotic leakage, potentially becoming a standard practice.
- What could go wrong
- This is a relatively small, early-stage trial (264 participants) comparing two surgical techniques, so results may not be definitive or widely applicable. The procedure itself carries minor risks like discomfort or allergic reaction to methylene blue.
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 264 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 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 diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications. 2. Aged between 18 and 85 years. 3. American Society of Anesthesiologists (ASA) physical status classification is I - III. 4. The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process. Exclusion Criteria: 1. Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections. 2. Patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests. 3. Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate \< 30 ml/min). 4. Patients with coagulation disorders (such as platelet count \< 50×10⁹/L, international normalized ratio (INR) \> 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted. 5. Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures. 6. Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy. 7. Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.
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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
1 site. 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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Nanchong Central Hospital
RECRUITINGNanchong, Sichuan, China
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