Anastomotic LeakageNCT07588386
The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After Surgery for Low Colorectal Cancer
A study testing electronic colonoscopy in people with Anastomotic Leakage, run by Nanchong Central Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether early postoperative colonoscopy is valuable in the early diagnosis of anastomotic leakage after surgery for low colorectal cancer.The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anastomotic Leakage
- What is being tested?
- electronic colonoscopy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2026to 30 Jun 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old.
- Pathologically diagnosed as colorectal adenocarcinoma.
- The distance between the lower edge of the tumor and the anal verge is ≤15cm.
- Accept laparoscopic or open radical resection and complete primary colorectal or colosal anastomosis.
- Voluntarily participate and sign the written informed consent.
Who cannot join
- Distant metastasis was confirmed by emergency operation, palliative operation or intraoperative metastasis (M1).
- Unsatisfactory anastomosis or poor blood circulation were found during the operation, and reinforcement suture or preventive colostomy were performed during the operation.
- There are serious contraindications for enteroscopy (such as acute myocardial infarction, severe cardiopulmonary insufficiency, blood coagulation dysfunction, etc.).
- Pregnant or lactating women.
- Previous history of colorectal surgery (except endoscopic polypectomy).
- Unable to understand or cooperate with the research process.
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
Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University
Nanchong, Sichuan, 637000
Yunhong Tian, Doctor, 86+13508087719, drtianyunhong@126.com
About this study
Official title: The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After Surgery for Low Colorectal Cancer:A Randomized Controlled Trial
The goal of this clinical trial is to learn whether early postoperative colonoscopy is valuable in the early diagnosis of anastomotic leakage after surgery for low colorectal cancer.The main questions it aims to answer are:
- Will the median diagnosis time of AL in the intervention group (early colonoscopy group) be significantly shorter than that in the control group?
- Can targeted treatment (such as endoscopic vacuum therapy (EVT)) be initiated earlier in the early colonoscopy group, thereby reducing the incidence of AL and the rate of unplanned re-laparotomy?
Read more
Researchers will compare the median diagnosis time of AL in the intervention group (early colonoscopy group) with the control group to observe whether early postoperative colonoscopy can detect anastomotic leakage earlier.
Participants will:
Experimental group (early colonoscopy group):
- Colonoscopy will be performed on the 5th to 8th day after surgery (the surgeon will decide the specific date within this time window based on the patient's recovery).
- Carry out adequate intestinal preparation before the examination (the specific plan is formulated according to the hospital's routine, which may involve antegrade or retrograde enema, etc., and needs to be recorded and standardized).
Control group (routine observation group):
- Receive standard postoperative management, including monitoring vital signs, abdominal signs, drainage fluid properties, etc.
- Only when clinical symptoms suspected of anastomotic leakage occur (such as persistent fever, worsening abdominal pain, turbid drainage fluid or stool samples), CT scan, gastrointestinal angiography or diagnostic colonoscopy should be performed according to clinical indications.
- Conditions
- Anastomotic Leakage
- Being tested
- electronic colonoscopy
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic colonoscopyBehavioural
Colonoscopy on days 5 to 8 after colorectal cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (early colonoscopy group) | Experimental | Not described Receives: Behavioral: electronic colonoscopy |
| Control group (routine observation group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis time lag: the number of days from the end of the operation (the last stitch of skin suturing) to the final diagnosis of AL (confirmed by imaging, endoscopic or surgical exploration).
Measured: day 30
Secondary outcomes (4)
Diagnostic efficacy: The sensitivity and specificity of early colonoscopy in diagnosing AL, etc.
Measured: day 8
Clinical outcomes: AL incidence rate within 30 days (divided into grades A, B, and C).
Measured: day 30
Total postoperative days of hospitalization.
Measured: 2 months
Safety indicators: the incidence of complications (such as bleeding, perforation, cardiovascular events) directly related to early enteroscopy.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start21 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakageStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588386
- Sponsor's protocol ID
- 2026 Review No. (050)
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2026
- Last updated
- 25 Jun 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After Surgery for Low Colorectal Cancer:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07588386
- Acronym / sponsor ID
- 2026 Review No. (050)
- Conditions
- Anastomotic Leakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 21 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 May 2026 (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.
The goal of this clinical trial is to learn whether early postoperative colonoscopy is valuable in the early diagnosis of anastomotic leakage after surgery for low colorectal cancer.The main questions it aims to answer are:
- Will the median diagnosis time of AL in the intervention group (early colonoscopy group) be significantly shorter than that in the control group?
- Can targeted treatment (such as endoscopic vacuum therapy (EVT)) be initiated earlier in the early colonoscopy group, thereby reducing the incidence of AL and the rate of unplanned re-laparotomy?
Researchers will compare the median diagnosis time of AL in the intervention group (early colonoscopy group) with the control group to observe whether early postoperative colonoscopy can detect anastomotic leakage earlier.
Participants will:
Experimental group (early colonoscopy group):
- Colonoscopy will be performed on the 5th to 8th day after surgery (the surgeon will decide the specific date within this time window based on the patient's recovery).
- Carry out adequate intestinal preparation before the examination (the specific plan is formulated according to the hospital's routine, which may involve antegrade or retrograde enema, etc., and needs to be recorded and standardized).
Control group (routine observation group):
- Receive standard postoperative management, including monitoring vital signs, abdominal signs, drainage fluid properties, etc.
- Only when clinical symptoms suspected of anastomotic leakage occur (such as persistent fever, worsening abdominal pain, turbid drainage fluid or stool samples), CT scan, gastrointestinal angiography or diagnostic colonoscopy should be performed according to clinical indications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (early colonoscopy group) | Experimental | Behavioral: electronic colonoscopy |
| Control group (routine observation group) | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years old.
- Pathologically diagnosed as colorectal adenocarcinoma.
- The distance between the lower edge of the tumor and the anal verge is ≤15cm.
- Accept laparoscopic or open radical resection and complete primary colorectal or colosal anastomosis.
- Voluntarily participate and sign the written informed consent.
Key exclusion criteria (6 listed)
- Distant metastasis was confirmed by emergency operation, palliative operation or intraoperative metastasis (M1).
- Unsatisfactory anastomosis or poor blood circulation were found during the operation, and reinforcement suture or preventive colostomy were performed during the operation.
- There are serious contraindications for enteroscopy (such as acute myocardial infarction, severe cardiopulmonary insufficiency, blood coagulation dysfunction, etc.).
- Pregnant or lactating women.
- Previous history of colorectal surgery (except endoscopic polypectomy).
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 |
|---|---|---|
| electronic colonoscopyColonoscopy on days 5 to 8 after colorectal cancer surgery | Behavioural | Experimental group (early colonoscopy group) |
Primary outcome
Diagnosis time lag: the number of days from the end of the operation (the last stitch of skin suturing) to the final diagnosis of AL (confirmed by imaging, endoscopic or surgical exploration).
Time frame: day 30
4 secondary outcomes
Diagnostic efficacy: The sensitivity and specificity of early colonoscopy in diagnosing AL, etc.
Time frame: day 8
Clinical outcomes: AL incidence rate within 30 days (divided into grades A, B, and C).
Time frame: day 30
Total postoperative days of hospitalization.
Time frame: 2 months
Safety indicators: the incidence of complications (such as bleeding, perforation, cardiovascular events) directly related to early enteroscopy.
Time frame: 1 month
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 25 Jun 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 electronic colonoscopy in people with Anastomotic Leakage, 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 5 inclusion and 6 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 25 Jun 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 (86+13508087719, drtianyunhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis time lag: the number of days from the end of the operation (the last stitch of skin suturing) to the final diagnosis of AL (confirmed by imaging, endoscopic or surgical exploration). (time frame: day 30). 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 25 Jun 2026.