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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05891301
Collaborator
(none)
737
1
12
61.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires set

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

Study Type:
Observational
Anticipated Enrollment :
737 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer After Surgery
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
questionnaires assessed patient with colorectal cancer after surgery

Patients with colorectal cancer who had a radical resection surgery.

Other: Questionnaires set
The contents of the questionnaire included gender, age, BMI, previous operation history, previous medication history, intraoperative blood loss, postoperative activity, 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.

Outcome Measures

Primary Outcome Measures

  1. gastrointestinal dysfunction [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.A score of 6 or greater is a diagnosis of gastrointestinal dysfunction.

Secondary Outcome Measures

  1. BMI [Baseline]

    Weight/(Height)²

  2. Smoking history [Baseline]

    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.

  3. Nutritional Risk [Baseline]

    It will be assessed by《European Nutritional Risk Screening 2002(NRS 2002)》.If the score ≥3, it indicates high nutritional risk.

  4. Medications [Baseline]

    History of use of chemotherapeutics, opiates, antithrombotic drugs.

  5. Past illnesses [Baseline]

    History of abdominal surgery, especially colon or rectum removal.

  6. Preoperative bowel preparation [one day before surgery]

    It will be assessed by 《Bristol stool form scale》.A 7-point scale describe different kinds of stool.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 XIAW Guangzhou Guangdong China 510080

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Wei Xia, Phd, Sun Yat-sun Unversity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wei XIA, PhD, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05891301
Other Study ID Numbers:
  • cwd-M1
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wei XIA, PhD, Associate Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2023