Colorectal CancerNCT06865638
Efficacy and Safety of Colorectal Anastomotic Leak Testing
A study testing Intraoperative leak testing in people with Colorectal Cancer and Leakage Testing, run by Nanchong Central Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Leakage Testing, Colorectal Surgery
- What is being tested?
- Intraoperative leak testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2024to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.
- Aged between 18 and 85 years.
- American Society of Anesthesiologists (ASA) physical status classification is I - III.
- The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.
Who cannot join
- Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.
- 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.
- Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate < 30 ml/min).
- 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.
- Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
- Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
- Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanchong Central Hospital
Nanchong, Sichuan
13508087719, drtianyunhong@126.com
About this study
Official title: A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.
To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery
- Conditions
- Colorectal Cancer, Leakage Testing, Colorectal Surgery, Complications, Anastomotic Leakage
- Being tested
- Intraoperative leak testing
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative leak testingProcedure or surgery
◦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.
| Study group | Role | What they receive |
|---|---|---|
| ≤5cm Rectal, Pre-chemo, Leak Test | Experimental | Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing. Receives: Procedure: Intraoperative leak testing |
| ≤5cm Rectal, Pre-chemo, No Leak Test | No intervention | Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing. |
| ≤5cm Rectal, No pre-chemo, Leak Test | Experimental | Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing. Receives: Procedure: Intraoperative leak testing |
| ≤5cm Rectal, No pre-chemo, No Leak Test | No intervention | Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing. |
| >5cm Colorectal, Pre-chemo, Leak Test | Experimental | Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing. Receives: Procedure: Intraoperative leak testing |
| >5cm Colorectal, Pre-chemo, No Leak Test | No intervention | Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing. |
| >5cm Colorectal, No pre-chemo, Leak Test | Experimental | Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing. Receives: Procedure: Intraoperative leak testing |
| >5cm Colorectal, No pre-chemo, No Leak Test | No intervention | Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Anastomotic Leak within 30 days
Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.
Measured: 30 days
Secondary outcomes (1)
Number of Participants with Postoperative Complications within 30 days
Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start22 Dec 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865638
- Sponsor's protocol ID
- 2025008
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06865638
- Acronym / sponsor ID
- 2025008
- Conditions
- Colorectal Cancer, Leakage Testing, Colorectal Surgery, Complications, Anastomotic Leakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 22 Dec 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ≤5cm Rectal, Pre-chemo, Leak Test | Experimental | Procedure: Intraoperative leak testingPatients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing. |
| ≤5cm Rectal, Pre-chemo, No Leak Test | No intervention | –Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing. |
| ≤5cm Rectal, No pre-chemo, Leak Test | Experimental | Procedure: Intraoperative leak testingPatients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing. |
| ≤5cm Rectal, No pre-chemo, No Leak Test | No intervention | –Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing. |
| >5cm Colorectal, Pre-chemo, Leak Test | Experimental | Procedure: Intraoperative leak testingPatients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing. |
| >5cm Colorectal, Pre-chemo, No Leak Test | No intervention | –Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing. |
| >5cm Colorectal, No pre-chemo, Leak Test | Experimental | Procedure: Intraoperative leak testingPatients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing. |
| >5cm Colorectal, No pre-chemo, No Leak Test | No intervention | –Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.
- Aged between 18 and 85 years.
- American Society of Anesthesiologists (ASA) physical status classification is I - III.
- The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.
Key exclusion criteria (7 listed)
- Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.
- 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.
- Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate < 30 ml/min).
- 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.
- Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | >5cm Colorectal, No pre-chemo, Leak Test, >5cm Colorectal, Pre-chemo, Leak Test, ≤5cm Rectal, No pre-chemo, Leak Test, ≤5cm Rectal, Pre-chemo, Leak Test |
Primary outcome
Number of Participants with Anastomotic Leak within 30 days
Time frame: 30 days
Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.
1 secondary outcome
Number of Participants with Postoperative Complications within 30 days
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative leak testing in people with Colorectal Cancer and Leakage Testing, run by Nanchong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunhong Tian, doctor (13508087719, drtianyunhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Anastomotic Leak within 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.