Evaluation of Outcomes From Treatment of Benign or Malignant Gastrointestinal Diseases

• Conditions: Gastrointestinal Disease

• Registration Number: NCT05115877
• Lead Sponsor: Methodist Health System

Brief Summary

This study will be a retrospective, registry study collecting data of patients who were diagnosed with benign or malignant gastrointestinal diseases. Data will be collected from patient's chart retrospectively once the patients have completed proper treatment follow up with physicians' practice.

Detailed Description

It is reported in the literature that the treatment of any gastrointestinal disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with gastrointestinal cancer continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. The goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity.

The main aim of this study is to evaluate and compare the outcomes from our treatment of benign or malignant gastrointestinal diseases through medical chart review.

There is a need to understand and improve the current diagnosis and treatment algorithm for gastrointestinal pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.

Study Timeline

• Study First Submitted: 2020-11-18
• Study Start: 2021-01-07
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-10
• Status Verified: 2023-04
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-17

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients diagnosed and treated for gastrointestinal diseases, benign or malignant from 2005 to 2030.
• Age ≥18 years

Exclusion Criteria

• Patients that are not diagnosed with or treated for gastrointestinal diseases
• Age <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall symptom	Jan 2005 - Jan 2030	Difficulty swallowing, Heartburn, Regurgitation, Chest pain, Weight Loss, Quality of life
Morbidity	Jan 2005 - Jan 2030	yes or no to individual disease
Overall survival	Jan 2005 - Jan 2030	from day of diagnosis or procedure to death date
Mortality	Jan 2005 - Jan 2030	death or life

Trial Locations

Locations (1)

Methodist Richardson Medical Center; 🇺🇸 Richardson, Texas, United States