Retrospective Review of Gastrointestinal System Endoscopy Procedures

NCT05012527 | Completed

• 1 other identifier: 2021s01
• Study Type: observational
• Target: 15,448
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endoscopy; Colonoscopy; Gastroscopy; Colonic Polyps; Endoscopy, Digestive System; Gastrointestinal Neoplasms; Biopsy

Outcome Measures

Primary Outcomes (14)

• 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)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Sultanbeyli State Hospital: lead

Study Sites (1)

Istanbul Sultanbeyli State Hospital

Istanbul, 34935, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colonic Polyps; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Muhammer Ergenç, MD

  Istanbul Sultanbeyli State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 19, 2021
• Study Start: June 11, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

TU (1)