Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients with colorectal cancer who had a radical resection surgery.

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.

Questionnaires set

Wei Xia, Phd

Wending Cao, Master

Wei Xia, PhD

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.

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.

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

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

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.

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.

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".

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".

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.

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.

Sun Yat-sen University

Associate Professor

Patients randomized to this arm will receive patient navigation with the goal of completing a follow-up colonoscopy within 12 months of a positive FIT result.

Patients will receive usual care screening opportunities

Receive up to 6 live phone calls with a patient navigator for education, barrier assessment, and barrier resolution to follow up colonoscopy

Patient navigation

Gloria Coronado, PhD

The prospective cohort study will evaluate the effectiveness of patient navigation in community health center settings. The investigators will collaborate with the advisory board, composed of key clinicians and patients, researchers, and policymakers, to establish a procedure to conduct and evaluate a patient navigation program that aims to increase rates of follow-up colonoscopy among diverse patient populations served by safety net clinics. Phase 1 will be a milestone-driven planning process in which the investigators will validate the risk prediction model and apply the risk prediction model to stratify the patients and adapt patient navigation materials for the local context. Phase II will be a large-scale, patient randomized-controlled trial that will include 1200 patients at a large 34-clinic community health center in Washington State.

The study will fulfill the following aims:

Aim 1: Validate externally the predictive risk score using Sea Mar CHC's robust data including 29,000 patients age-eligible for colorectal cancer screening; stratify patients according to risk of non-adherence to follow-up colonoscopy; and adapt patient navigation program for the local context.

Aim 2: Assess the effectiveness, costs, and cost-effectiveness of a centralized, phone-based patient navigation program for follow-up colonoscopy receipt for patients at moderate risk or high risk for non-adherence.

Aim 3: Assess differences in the intervention arms in secondary outcomes (e.g. time to colonoscopy receipt, no-show/canceled appointments, colonoscopy quality) and moderators of intervention effectiveness (e.g. probability level, intervention dose, and patient age, ethnicity, and sex)

Predicting and Addressing Colonoscopy in Safety Net Settings

Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer	NCT05891301	Patient With Co... Surgery	Questionnaires ...	18 Years -	Sun Yat-sen University
Predicting and Addressing Colonoscopy in Safety Net Settings	NCT03925883	Colorectal Canc...	Patient navigat...	50 Years - 75 Years	Kaiser Permanente
Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer	NCT05891301	Patient With Co... Surgery	Questionnaires ...	18 Years -	Sun Yat-sen University
Predicting and Addressing Colonoscopy in Safety Net Settings	NCT03925883	Colorectal Canc...	Patient navigat...	50 Years - 75 Years	Kaiser Permanente

Spots Global Cancer Trial Database for risk prediction model