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Trial Title:
Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer
NCT ID:
NCT05891301
Condition:
Patient With Colorectal Cancer
Surgery
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer
surgery
gastrointestinal dysfunction
risk prediction model
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Questionnaires set
Description:
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.
Arm group label:
questionnaires assessed patient with colorectal cancer after surgery
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 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.
Criteria for eligibility:
Study pop:
516 cases needed to be included in the modeling group and 221 cases needed to be included
in the validation group
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
XIAW
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Xia, PhD
Phone:
18823359471
Email:
xiaw23@mail.sysu.edu.cn
Start date:
May 1, 2023
Completion date:
May 1, 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891301
