Efficacy and Safety of Colorectal Anastomotic Leak Testing
NCT ID: NCT06865638
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
264 participants
INTERVENTIONAL
2024-12-22
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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≤5cm Rectal, Pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing.
Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
≤5cm Rectal, Pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
No interventions assigned to this group
≤5cm Rectal, No pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
≤5cm Rectal, No pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.
No interventions assigned to this group
>5cm Colorectal, Pre-chemo, Leak Test
Patients with colorectal cancer \> 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing.
Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
>5cm Colorectal, Pre-chemo, No Leak Test
Patients with colorectal cancer \> 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
No interventions assigned to this group
>5cm Colorectal, No pre-chemo, Leak Test
Patients with colorectal cancer \> 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
>5cm Colorectal, No pre-chemo, No Leak Test
Patients with colorectal cancer \> 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.
No interventions assigned to this group
Interventions
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Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Nanchong Central Hospital
OTHER_GOV
Responsible Party
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Locations
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Nanchong Central Hospital
Nanchong, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2025008
Identifier Type: -
Identifier Source: org_study_id
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