Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer

NCT ID: NCT05891301

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 737 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-01

Brief 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.

Conditions

Patient With Colorectal Cancer; Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

questionnaires assessed patient with colorectal cancer after surgery

Patients with colorectal cancer who had a radical resection surgery.

Questionnaires set

Intervention Type: OTHER

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.

Interventions

Questionnaires set

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Wei XIA, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Xia, Phd

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sun Unversity

Locations

XIAW

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Xia, Phd

Role: CONTACT

xiaw23@mail.sysu.edu.cn

18823359471

Wending Cao, Master

Role: CONTACT

caowd@mail.sysu.edu.cn

18616306742

Facility Contacts

Wei Xia, PhD

Role: primary

xiaw23@mail.sysu.edu.cn

18823359471

Other Identifiers

cwd-M1

Identifier Type: -

Identifier Source: org_study_id