Validation of a Model for Predicting Anastomotic Leakage

NCT05646290 | Completed

• 1 other identifier: TJ-IRB20211255
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.

Conditions

Gastric Cancer

Keywords

machine learning; anastomotic leakage; total and proximal gastrectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of anastomotic leakage

  Within 30 days after operation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastric cancer patients undergoing total or proximal gastrectomy in five medical centers (Tongji Hospital, Wuhan No. 1 Hospital, Xianning Central Hospital, Huanggang Central Hospital and Jingzhou Central Hospital) are included in this perspective study.

You may qualify if:

• Aged older than 18 years and younger than 85 years.
• Primary gastric adenocarcinoma confirmed by preoperative pathology.
• Expected curative resection via total or proximal gastrectomy.
• American Society of Anesthesiologists (ASA) class I, II, or III.
• Written informed consent.

You may not qualify if:

• Pregnant or breastfeeding women.
• Severe mental disorder or language communication disorder.
• Other surgical procedures of gastrectomy is performed.
• Interrupted of surgery for more than 30 minutes due to any cause.
• Malignant tumors with other organs

Sponsors & Collaborators

• Jichao Qin: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 12, 2022
• Study Start: January 6, 2022
• Primary Completion: March 15, 2024
• Study Completion: May 6, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

CN (1)