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Completed

NCT Number: NCT05012527

Retrospective Review of Gastrointestinal System Endoscopy Procedures

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

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Key information

Conditions

Endoscopy Biopsy Colonic Polyps Colonoscopy Digestive System Diseases Digestive System Neoplasms Endoscopy, Digestive System Gastrointestinal Diseases Gastrointestinal Neoplasms Gastroscopy Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Sultanbeyli State Hospital

Istanbul, 34935, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Age

    Time frame: During 3 months (retrospective endoscopy data review)

    Age distribution of patients in endoscopic procedures and histopathological examinations

  2. Gender

    Time frame: During 3 months (retrospective endoscopy data review)

    Sex distribution of patients in endoscopic procedures and histopathological examinations

  3. Type of endoscopy

    Time frame: During 3 months (retrospective endoscopy data review)

    Number of each endoscopy, Type (esophagogastroduodenoscopy, colonoscopy, rectosigmoidoscopy)

  4. Indications

    Time frame: During 3 months (retrospective endoscopy data review)

    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)

  5. Procedure-related complications rates

    Time frame: During 3 months (retrospective endoscopy data review)

    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)

  6. Prevalence of benign/malign gastrointestinal disease in the endoscopy

    Time frame: During 3 months (retrospective endoscopy data review)

    The patients with benign gastrointestinal disease / the total patients

    The patients with malign gastrointestinal disease / the total patients

  7. Polyp/tumor detection rate of screening endoscopy

    Time frame: During 3 months (retrospective endoscopy data review)

    The patients with polyp / the total number of screening endoscopy patients

    The patients with tumor / the total number of screening endoscopy patients

  8. Polyp/tumor detection rate of symptomatic patients' endoscopy

    Time frame: During 3 months (retrospective endoscopy data review)

    The patients with polyp / the total number of symptomatic patients endoscopy

    The patients with tumor / the total number of symptomatic patients endoscopy

  9. Polyps localization and frequency

    Time frame: During 3 months (retrospective endoscopy data review)

    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)

  10. Non-neoplastic biopsy results

    Time frame: During 3 months (retrospective endoscopy data review)

    The patients with non-neoplastic biopsy results / the total patients

  11. Prevalence of gastric/bowel diseases in histopathology

    Time frame: During 3 months (retrospective endoscopy data review)

    The patients with gastric disease / the total patients

    The patients with bowel disease / the total patients

  12. Prevalence of advanced neoplasia

    Time frame: During 3 months (retrospective endoscopy data review)

    The patients with advanced neoplasia / the total patients

  13. Prevalence of gastric/colorectal cancer

    Time frame: During 3 months (retrospective endoscopy data review)

    The patients with gastric cancer / the total patients

    The patients with colorectal cancer / the total patients

  14. Completeness rate of the procedures

    Time frame: During 3 months (retrospective endoscopy data review)

    The number of completed procedures / total number of procedures

Sponsors and collaborators

Lead sponsor

Istanbul Sultanbeyli State Hospital

Other Gov

Registry information

Acronym: RRGIE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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