Retrospective Review of Gastrointestinal System Endoscopy Procedures

Colonoscopy Clinical Trial

— RRGIE  

Official title:

Retrospective Review of Gastrointestinal System Endoscopy Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012527
• Other study ID #: 2021s01
• Status: Completed
• Start date: June 11, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Istanbul Sultanbeyli State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15448
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Turkey	Istanbul Sultanbeyli State Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sultanbeyli State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Age distribution of patients in endoscopic procedures and histopathological examinations	During 3 months (retrospective endoscopy data review)
Primary	Gender	Sex distribution of patients in endoscopic procedures and histopathological examinations	During 3 months (retrospective endoscopy data review)
Primary	Type of endoscopy	Number of each endoscopy, Type (esophagogastroduodenoscopy, colonoscopy, rectosigmoidoscopy)	During 3 months (retrospective endoscopy data review)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Non-neoplastic biopsy results	The patients with non-neoplastic biopsy results / the total patients	During 3 months (retrospective endoscopy data review)
Primary	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)
Primary	Prevalence of advanced neoplasia	The patients with advanced neoplasia / the total patients	During 3 months (retrospective endoscopy data review)
Primary	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)
Primary	Completeness rate of the procedures	The number of completed procedures / total number of procedures	During 3 months (retrospective endoscopy data review)