Colorectal CancerNCT06404554
A Prediction Model of Anastomotic Stricture After Rectal Cancer
An observational study of Colorectal Cancer and Rectal Cancer, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Rectal Cancer, Anastomotic Stenosis
- What is being tested?
- without any intervention
- How many people
- 1,542 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Apr 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent anterior resection for rectal cancer at the Department of Gastrointestinal Surgery, Northern Jiangsu People's Hospital. All participants received radical treatment consistent with total mesorectal excision (TME) principles
Who may be able to join
- pathological confirmation of rectal cancer;
- eligibility for surgical intervention;
- undergoing first rectal cancer surgery;
- acquisition of written informed consent from patients and their families;
- no history of hypertrophic scar or allergic predispositions.
Who cannot join
- absence of postoperative follow-up or anastomosis details;
- patients subjected to Hartmann or Miles procedures;
- emergency surgery candidates due to conditions like perforation or obstruction;
- diagnosis of multiple primary malignancies;
- intraoperative discovery of widespread implant metastases within the abdominal cavity;
- severe comorbidities;
- anastomotic recurrence of rectal cancer;
- patients who had undergone stapled hemorrhoidopexy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prediction Model of Anastomotic Stricture After Rectal Cancer: a Retrospective Cohort Analysis
Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.
Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.
- Conditions
- Colorectal Cancer, Rectal Cancer, Anastomotic Stenosis
- Being tested
- without any intervention
- Keywords
- nomogram, rectal cancer, anastomotic stricture
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without any interventionOther
without any intervention
| Study group | Role | What they receive |
|---|---|---|
| patients with anastomotic stricture | without any intervention, patients diagnose as anastomotic stricture after rectal cancer surgery Receives: Other: without any intervention | |
| patients without anastomotic stricture | without any intervention, patients does not diagnose as anastomotic stricture after rectal cancer surgery Receives: Other: without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients with anastomotic stricture
Within six months after rectal cancer surgery, the patient was diagnosed with benign stricture of the rectal anastomosis
Measured: up to six months
patients without anastomotic stricture
Within six months after rectal cancer surgery, the patient was not diagnosed with benign stricture of the rectal anastomosis
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jan 2024
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daorong Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404554
- Sponsor's protocol ID
- NorthernJiangsu004
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prediction Model of Anastomotic Stricture After Rectal Cancer: a Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT06404554
- Acronym / sponsor ID
- NorthernJiangsu004
- Conditions
- Colorectal Cancer, Rectal Cancer, Anastomotic Stenosis
- Keywords
- nomogram, rectal cancer, anastomotic stricture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,542 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 May 2024 (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.
Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.
Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with anastomotic stricture | – | Other: without any interventionwithout any intervention, patients diagnose as anastomotic stricture after rectal cancer surgery |
| patients without anastomotic stricture | – | Other: without any interventionwithout any intervention, patients does not diagnose as anastomotic stricture after rectal cancer surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent anterior resection for rectal cancer at the Department of Gastrointestinal Surgery, Northern Jiangsu People's Hospital. All participants received radical treatment consistent with total mesorectal excision (TME) principles
Key inclusion criteria (5 listed)
- pathological confirmation of rectal cancer;
- eligibility for surgical intervention;
- undergoing first rectal cancer surgery;
- acquisition of written informed consent from patients and their families;
- no history of hypertrophic scar or allergic predispositions.
Key exclusion criteria (8 listed)
- absence of postoperative follow-up or anastomosis details;
- patients subjected to Hartmann or Miles procedures;
- emergency surgery candidates due to conditions like perforation or obstruction;
- diagnosis of multiple primary malignancies;
- intraoperative discovery of widespread implant metastases within the abdominal cavity;
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 |
|---|---|---|
| without any interventionwithout any intervention | Other | patients with anastomotic stricture, patients without anastomotic stricture |
Primary outcome
patients with anastomotic stricture
Time frame: up to six months
Within six months after rectal cancer surgery, the patient was diagnosed with benign stricture of the rectal anastomosis
patients without anastomotic stricture
Time frame: up to six months
Within six months after rectal cancer surgery, the patient was not diagnosed with benign stricture of the rectal anastomosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Colorectal Cancer and Rectal Cancer, run by Northern Jiangsu People's 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 8 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: finished, as of the sponsor's last update on 8 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patients with anastomotic stricture (time frame: up to six months). The study lists 2 primary outcomes in all. 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 8 May 2024.