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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891301
• Other study ID #: cwd-M1
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2023
• Source: Sun Yat-sen University
• Contact: Wei Xia, Phd
• Phone: 18823359471
• Email: xiaw23[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 737
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Surgery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	XIAW	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days after surgery
Secondary	BMI	Weight/(Height)²	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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".	Baseline
Secondary	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".	Baseline
Secondary	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.	one day before surgery
Secondary	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.	one day after surgery