Patient With Colorectal CancerNCT05891301
Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer
An observational study of Patient With Colorectal Cancer and Surgery, run by Sun Yat-sen University at 1 site in China.
Trial summary
To understand the current situation of the postoperative gastrointestinal dysfunction in patients with colorectal cancer effect a radical cure, and analyze the risk factors, and build the colorectal cancer radical surgery in patients with gastrointestinal dysfunction risk prediction nomogram model decision tree… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient With Colorectal Cancer, Surgery
- What is being tested?
- Questionnaires set
- How many people
- 737 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 516 cases needed to be included in the modeling group and 221 cases needed to be included in the validation group
Who may be able to join
- Patients aged ≥18 years;
- patients with diagnosed colon or rectal cancer;
- Patients diagnosed as having undergone radical resection of colorectal cancer;
- Patients who can read and communicate in Chinese.
Who cannot join
- Patients with multiple cancers;
- Patients who are unable to communicate due to dementia, language disorders or postoperative mental disorder or hearing impairment.
- withdrawl Criteria：
- Patients with postoperative mechanical obstruction;
- Patients requiring reoperation for any indication prior to the initiation of formal evaluation of POGD.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XIAW
Guangzhou, Guangdong, 510080
Wei Xia, PhD, 18823359471, xiaw23@mail.sysu.edu.cn
About this study
Official title: Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer After Surgery
To understand the current situation of the postoperative gastrointestinal dysfunction in patients with colorectal cancer effect a radical cure, and analyze the risk factors, and build the colorectal cancer radical surgery in patients with gastrointestinal dysfunction risk prediction nomogram model decision tree classification and regression tree model, through internal validation evaluation the performance of the two models in the modeling data set and dividing the postoperative gastrointestinal dysfunction risk level.Two risk prediction models were used to carry out external verification, evaluate the clinical practicability and effectiveness of the model, and provide reference for further promotion of the model.
Read the detailed description
Colorectal cancer is characterized by high morbidity and mortality. Surgical treatment is the main treatment for colorectal cancer. Surgery is the best treatment for long-term survival.
Surgery is a destructive operation, can lead to local tissue injury, physical barrier damage, causes the patient's body, and a series of metabolism, neuroendocrine and immune response, all of which can cause local inflammation or systemic inflammatory response, also leads to occurrence of related complications, such as abdominal and pelvic infection, fever, anastomotic infection and fistula, intestinal obstruction, etc., Thus increasing the risk of postoperative complications. The trauma and irritation of gastrointestinal tract caused postoperative gastrointestinal dysfunction.
The procedure of surgery is accompanied by anesthesia, and the anesthesia mode of gastrointestinal surgery is mainly general anesthesia. Opioid analgesics are one of the most important components of general anesthesia. The most common side effects of opioid analgesics include postoperative intestinal obstruction, nausea and vomiting, chills and urinary retention. The use of anesthetic drugs further aggravated the postoperative gastrointestinal dysfunction.
At the same time, laparoscopic surgery must establish pneumoperitoneum pressure. In recent years, studies have suggested that pneumoperitoneum pressure can lead to changes in the body's internal environment, resulting in a series of pathophysiological changes such as tissue ischemia, intestinal edema, and release of inflammatory factors in the gastrointestinal tract, resulting in dysfunction of gastrointestinal function.
All the above reasons lead to gastrointestinal dysfunction as the highest complication after radical resection of colorectal cancer.A review of previous literature shows that there is no predictive assessment tool for gastrointestinal dysfunction in patients after radical resection of colorectal cancer.Therefore, it is necessary to construct a risk prediction model for patients after radical resection of colorectal cancer, and to verify the clinical practicability of the model through external verification.
- Conditions
- Patient With Colorectal Cancer, Surgery
- Being tested
- Questionnaires set
- Keywords
- colorectal cancer, surgery, gastrointestinal dysfunction, risk prediction model
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires setOther
The contents of the questionnaire included gender, age, BMI, previous operation history, previous medication history, smoking history,patient mobility in the hospital, etc.Questionnaire was completed on the first postoperative day.From the third day to the end of the seventh day, patients were evaluated daily for gastrointestinal dysfunction.Postoperative mobility was assessed daily.
| Study group | Role | What they receive |
|---|---|---|
| questionnaires assessed patient with colorectal cancer after surgery | Patients with colorectal cancer who had a radical resection surgery. Receives: Other: Questionnaires set |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal dysfunction
The gastrointestinal dysfunction will be assessed by 《Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system(I-FEED)》.The questionnaire consisted of 5 items.The scale contains five items, with the highest score of 3 and the lowest score of 0 for each item. Items include: tolerance to eating, presence of nausea, presence of vomiting, presence of bloating, duration of symptoms.A score of 6 or greater is a diagnosis of gastrointestinal dysfunction.
Measured: 3 days after surgery
Secondary outcomes (7)
BMI
Weight/(Height)²
Measured: Baseline
Smoking history
Smoking history will be assessed by 《Patient General Data Collection Form》,described by "yes" or "not".If patient has smoking history, the form will record how many cigarettes are smoked per day.
Measured: Baseline
Nutritional Risk
It will be assessed by《European Nutritional Risk Screening 2002(NRS 2002)》.If the score ≥3, it indicates high nutritional risk.The scale contains three items, namely, disease severity, nutritional status, and age. Among them, the highest score of disease severity and nutritional status was 3 and the lowest score was 0. Age ≥70 years is one point.
Measured: Baseline
Previous medication history
Medications history will be assessed by 《Patient General Data Collection Form》,described by "History of use of chemotherapeutics" 、"History of use of opiates"、"History of use of antithrombotic drugs" or "not".
Measured: Baseline
Previous operation history
Previous operation history will be assessed by 《Patient General Data Collection Form》,described by "History of non-abdominal surgery" 、"History of colectomy surgery"、"History of rectotomy surgery"、"History of other abdominal surgery" or "none".
Measured: Baseline
Preoperative bowel preparation
It will be assessed by 《Bristol stool form scale》.Divided into 7 types, type 1 stool is granular, difficult to discharge. Type 2 is salami, which is hard. Type 3 is a strip with a cracked surface. Type 4 is strip, smooth surface, soft texture, easy to discharge. Type 5 stools are clumpy and soft in texture. Type 6 is a mushy loose stool. Type 7 is watery stool.
Measured: one day before surgery
Patient Mobility in the hospital
Patient Mobility l will be assessed by 《Inter-rater reliability of the Johns Hopkins Highest Level of Mobility Scale (JH-HLM)》.The maximum score of the scale is 8 points, 1 to 3 points means that only bed activities can be carried out, 4-5 points means that bedside activities can be carried out, and 6-8 points means that under-bed activities can be carried out. The higher the score, the higher the level of activity.
Measured: one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 737 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, Phd, Principal investigator, Sun Yat-sun Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891301
- Sponsor's protocol ID
- cwd-M1
- Status last verified
- Jul 2023
- First submitted
- 27 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer After Surgery
- ClinicalTrials.gov ID
- NCT05891301
- Acronym / sponsor ID
- cwd-M1
- Conditions
- Patient With Colorectal Cancer, Surgery
- Keywords
- colorectal cancer, surgery, gastrointestinal dysfunction, risk prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 737 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 6 Jun 2023 (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 understand the current situation of the postoperative gastrointestinal dysfunction in patients with colorectal cancer effect a radical cure, and analyze the risk factors, and build the colorectal cancer radical surgery in patients with gastrointestinal dysfunction risk prediction nomogram model decision tree classification and regression tree model, through internal validation evaluation the performance of the two models in the modeling data set and dividing the postoperative gastrointestinal dysfunction risk level.Two risk prediction models were used to carry out external verification, evaluate the clinical practicability and effectiveness of the model, and provide reference for further promotion of the model.
Detailed description
Colorectal cancer is characterized by high morbidity and mortality. Surgical treatment is the main treatment for colorectal cancer. Surgery is the best treatment for long-term survival.
Surgery is a destructive operation, can lead to local tissue injury, physical barrier damage, causes the patient's body, and a series of metabolism, neuroendocrine and immune response, all of which can cause local inflammation or systemic inflammatory response, also leads to occurrence of related complications, such as abdominal and pelvic infection, fever, anastomotic infection and fistula, intestinal obstruction, etc., Thus increasing the risk of postoperative complications. The trauma and irritation of gastrointestinal tract caused postoperative gastrointestinal dysfunction.
The procedure of surgery is accompanied by anesthesia, and the anesthesia mode of gastrointestinal surgery is mainly general anesthesia. Opioid analgesics are one of the most important components of general anesthesia. The most common side effects of opioid analgesics include postoperative intestinal obstruction, nausea and vomiting, chills and urinary retention. The use of anesthetic drugs further aggravated the postoperative gastrointestinal dysfunction.
At the same time, laparoscopic surgery must establish pneumoperitoneum pressure. In recent years, studies have suggested that pneumoperitoneum pressure can lead to changes in the body's internal environment, resulting in a series of pathophysiological changes such as tissue ischemia, intestinal edema, and release of inflammatory factors in the gastrointestinal tract, resulting in dysfunction of gastrointestinal function.
All the above reasons lead to gastrointestinal dysfunction as the highest complication after radical resection of colorectal cancer.A review of previous literature shows that there is no predictive assessment tool for gastrointestinal dysfunction in patients after radical resection of colorectal cancer.Therefore, it is necessary to construct a risk prediction model for patients after radical resection of colorectal cancer, and to verify the clinical practicability of the model through external verification.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaires assessed patient with colorectal cancer after surgery | – | Other: Questionnaires setPatients with colorectal cancer who had a radical resection surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 516 cases needed to be included in the modeling group and 221 cases needed to be included in the validation group
Key inclusion criteria (4 listed)
- Patients aged ≥18 years;
- patients with diagnosed colon or rectal cancer;
- Patients diagnosed as having undergone radical resection of colorectal cancer;
- Patients who can read and communicate in Chinese.
Key exclusion criteria (5 listed)
- Patients with multiple cancers;
- Patients who are unable to communicate due to dementia, language disorders or postoperative mental disorder or hearing impairment.
- withdrawl Criteria：
- Patients with postoperative mechanical obstruction;
- Patients requiring reoperation for any indication prior to the initiation of formal evaluation of POGD.
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 |
|---|---|---|
| Questionnaires setThe contents of the questionnaire included gender, age, BMI, previous operation history, previous medication history, smoking history,patient mobility in the hospital, etc.Questionnaire was completed on the first postoperative day.From the third day to the end of the seventh day, patients were evaluated daily for gastrointestinal dysfunction.Postoperative mobility was assessed daily. | Other | questionnaires assessed patient with colorectal cancer after surgery |
Primary outcome
gastrointestinal dysfunction
Time frame: 3 days after surgery
The gastrointestinal dysfunction will be assessed by 《Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system(I-FEED)》.The questionnaire consisted of 5 items.The scale contains five items, with the highest score of 3 and the lowest score of 0 for each item. Items include: tolerance to eating, presence of nausea, presence of vomiting, presence of bloating, duration of symptoms.A score of 6 or greater is a diagnosis of gastrointestinal dysfunction.
7 secondary outcomes
BMI
Time frame: Baseline
Smoking history
Time frame: Baseline
Nutritional Risk
Time frame: Baseline
Previous medication history
Time frame: Baseline
Previous operation history
Time frame: Baseline
Preoperative bowel preparation
Time frame: one day before surgery
Patient Mobility in the hospital
Time frame: one day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Patient With Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
RecruitingPhase 1/2
LYL273 for Patients With Relapsed or Refractory mCRC
Colorectal Cancer
RecruitingPhase 1
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
Metastatic Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma
Not yet recruitingObservational study
SGA-OCRC: Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarians With Resectable Colorectal Cancer
Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer
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.
Wei Xia, Phd principal investigator
Sun Yat-sun Unversity
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 Patient With Colorectal Cancer and Surgery, run by Sun Yat-sen University 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 5 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 27 Jul 2023. 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?
Contact Wei Xia, Phd (18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal dysfunction (time frame: 3 days 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 27 Jul 2023.