Anastomotic Leak RectumNCT05610904
Evaluation of AL Prediction for Rectal Cancer
A study testing Prediction model evaluation in people with Anastomotic Leak Rectum, run by Changhai Hospital at 1 site in China.
Trial summary
Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anastomotic Leak Rectum
- What is being tested?
- Prediction model evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2022to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years
- Adenocarcinoma confirmed by pathology
- Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal edge was less than or equal to 12cm
- Preoperative imaging diagnosis was cTxNxM0
- No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, and no invasion of adjacent organs)
- The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia
- Voluntarily sign the informed consent form
Who cannot join
- Previous history of malignant tumor
- Simultaneous multiple primary colorectal cancer
- Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery
- Patients with familial adenomatous polyposis and active inflammatory bowel disease
- A history of severe mental illness
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- pregnant or lactating women
- Patients with uncontrolled infection before operation
- The investigator did not consider the patient to be eligible for the trial
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Evaluation of a Machine Learning Based Anastomotic Leakage Prediction Model After Anterior Resection for Rectal cancer-a Multicenter, Prospective, Randomized Controlled Study
Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.
- Conditions
- Anastomotic Leak Rectum
- Being tested
- Prediction model evaluation
- Keywords
- Anastomotic Leak, rectal cancer, machine learning
- Medical subject headings
- Anastomotic Leak, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction model evaluationDiagnostic test
a machine learning based anastomotic leakage prediction model
| Study group | Role | What they receive |
|---|---|---|
| Surgeon evaluation | No intervention | Not described |
| Surgeon combining with model evaluation | Experimental | Not described Receives: Diagnostic Test: Prediction model evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of stoma implementation
Accuracy of stoma implementation: the number of anastomotic leakage patients with stoma and none anastomotic leakage patients without stoma to the number of total patients.
Measured: 1 months after surgery
Secondary outcomes (4)
Sensitivity and specificity in the prediction of anastomotic leakage
Measured: 1 months after surgery
Grade C leakage rate
Measured: 1 months after surgery
Preventive stoma rate
Measured: 1 months after surgery
Rate of stoma reverse
Measured: 3-6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start10 Dec 2022 (estimated)
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leak RectumStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610904
- Sponsor's protocol ID
- CHALP001
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Machine Learning Based Anastomotic Leakage Prediction Model After Anterior Resection for Rectal cancer-a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05610904
- Acronym / sponsor ID
- CHALP001
- Conditions
- Anastomotic Leak Rectum
- Keywords
- Anastomotic Leak, rectal cancer, machine learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 10 Dec 2022 (estimated)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 9 Nov 2022 (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.
Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon evaluation | No intervention | – |
| Surgeon combining with model evaluation | Experimental | Diagnostic Test: Prediction model evaluation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18-75 years
- Adenocarcinoma confirmed by pathology
- Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal edge was less than or equal to 12cm
- Preoperative imaging diagnosis was cTxNxM0
- No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, and no invasion of adjacent organs)
Key exclusion criteria (9 listed)
- Previous history of malignant tumor
- Simultaneous multiple primary colorectal cancer
- Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery
- Patients with familial adenomatous polyposis and active inflammatory bowel disease
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 |
|---|---|---|
| Prediction model evaluationa machine learning based anastomotic leakage prediction model | Diagnostic test | Surgeon combining with model evaluation |
Primary outcome
Accuracy of stoma implementation
Time frame: 1 months after surgery
Accuracy of stoma implementation: the number of anastomotic leakage patients with stoma and none anastomotic leakage patients without stoma to the number of total patients.
4 secondary outcomes
Sensitivity and specificity in the prediction of anastomotic leakage
Time frame: 1 months after surgery
Grade C leakage rate
Time frame: 1 months after surgery
Preventive stoma rate
Time frame: 1 months after surgery
Rate of stoma reverse
Time frame: 3-6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prediction model evaluation in people with Anastomotic Leak Rectum, run by Changhai 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of stoma implementation (time frame: 1 months after surgery). 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 9 Nov 2022.