Retrospective Review of Gastrointestinal System Endoscopy Procedures (RRGIE)

The aim of the study is retrospectively evaluating all features of endoscopic and pathological diagnoses of cases who underwent upper and lower gastrointestinal endoscopy.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasms; Colonic Polyps; Endoscopy; Colonoscopy; Gastroscopy; Endoscopy, Digestive System; Biopsy

Detailed Description

Gastrointestinal system endoscopy has an important place in the diagnosis and treatment of many diseases related to this system and provides an alternative to current surgical methods with its ever-expanding field of application. Upper and lower gastrointestinal endoscopy procedures are performed with many indications, such as new complaints in the gastrointestinal tract at the age of 50 and over, family history of gastrointestinal malignancy. In addition, the importance of endoscopy is gradually increasing as tissue and cell samples can be taken for histopathological studies and endoscopic treatment of some diseases.

The aim of the study is to review patients' indications, distribution by age and gender, frequency of lesions diagnosed on endoscopy, prevalence, size, histology and location of polyps detected and excised, results of endoscopic and pathological diagnoses.

The study population consists of the patients who were examined at the Istanbul Sultanbeyli State Hospital Endoscopy Unit between 01.01.2016 and 01.01.2021.

The patients' data will be scanned retrospectively by accessing their files from the computer database.

• Study Type: Observational
• Enrollment (Actual): 15448

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34935
    • Istanbul Sultanbeyli State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of the patients who were examined at the Istanbul Sultanbeyli State Hospital Endoscopy Unit between 01.01.2016 and 01.01.2021.

Description

Inclusion Criteria:

• Adult patients (over 18 years old)
• Patients who have undergone the procedure in our endoscopy unit

Exclusion Criteria:

• Under 18 years old
• Patients whose information cannot be accessed in the system records.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age distribution of patients in endoscopic procedures and histopathological examinations	During 3 months (retrospective endoscopy data review)
Gender	Sex distribution of patients in endoscopic procedures and histopathological examinations	During 3 months (retrospective endoscopy data review)
Type of endoscopy	Number of each endoscopy, Type (esophagogastroduodenoscopy, colonoscopy, rectosigmoidoscopy)	During 3 months (retrospective endoscopy data review)
Indications	Number of endoscopic indications, Type (Abnormal imaging, GI bleeding, Anemia, Screening and surveillance, Diarrhea, Constipation, Abdominal pain, Weight loss, Dyspepsia, Heartburn, Dysphagia, Odynophagia, Upper belly pain or chest pain that is not heart-related, Intractable vomiting, Bleeding in the upper, Persistent gastroesophageal reflux symptoms, Occult gastrointestinal bleeding, Other)	During 3 months (retrospective endoscopy data review)
Procedure-related complications rates	The patients with complications / the total patients Number of adverse events; early or late (within 1 month), related to the endoscopic procedure, Type (cardiopulmonary complication, gastrointestinal bleeding, perforation, mortality)	During 3 months (retrospective endoscopy data review)
Prevalence of benign/malign gastrointestinal disease in the endoscopy	The patients with benign gastrointestinal disease / the total patients The patients with malign gastrointestinal disease / the total patients	During 3 months (retrospective endoscopy data review)
Polyp/tumor detection rate of screening endoscopy	The patients with polyp / the total number of screening endoscopy patients The patients with tumor / the total number of screening endoscopy patients	During 3 months (retrospective endoscopy data review)
Polyp/tumor detection rate of symptomatic patients' endoscopy	The patients with polyp / the total number of symptomatic patients endoscopy The patients with tumor / the total number of symptomatic patients endoscopy	During 3 months (retrospective endoscopy data review)
Polyps localization and frequency	The patients with polyp / the total patients Number of polyp localizations, Type (Rectum, Sigmoid colon, Descending colon, Splenic flexure, Transverse colon, Hepatic flexure, Ascending colon, Caecum, Multiple localization)	During 3 months (retrospective endoscopy data review)
Non-neoplastic biopsy results	The patients with non-neoplastic biopsy results / the total patients	During 3 months (retrospective endoscopy data review)
Prevalence of gastric/bowel diseases in histopathology	The patients with gastric disease / the total patients The patients with bowel disease / the total patients	During 3 months (retrospective endoscopy data review)
Prevalence of advanced neoplasia	The patients with advanced neoplasia / the total patients	During 3 months (retrospective endoscopy data review)
Prevalence of gastric/colorectal cancer	The patients with gastric cancer / the total patients The patients with colorectal cancer / the total patients	During 3 months (retrospective endoscopy data review)
Completeness rate of the procedures	The number of completed procedures / total number of procedures	During 3 months (retrospective endoscopy data review)

Collaborators and Investigators

• Sponsor: Istanbul Sultanbeyli State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 2, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Polyps
• Other Study ID Numbers: 2021s01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No