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

NCT05891301 | Unknown DMC

• 1 other identifier: cwd-M1
• Study Type: observational
• Target: 737
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient With Colorectal Cancer; Surgery

Keywords

colorectal cancer; surgery; gastrointestinal dysfunction; risk prediction model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• BMI

  Baseline

• Smoking history

  Baseline

• Nutritional Risk

  Baseline

• Previous medication history

  Baseline

• Previous operation history

  Baseline

Study Arms (1)

questionnaires assessed patient with colorectal cancer after surgery

Patients with colorectal cancer who had a radical resection surgery.

Other: Questionnaires set

Interventions

Questionnaires set 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.

questionnaires assessed patient with colorectal cancer after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

516 cases needed to be included in the modeling group and 221 cases needed to be included in the validation group

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

XIAW

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Wei Xia, Phd

  Sun Yat-sun Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xia, Phd

CONTACT

18823359471; xiaw23@mail.sysu.edu.cn

Wending Cao, Master

CONTACT

18616306742; caowd@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 6, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)