EndoscopyRRGIENCT05012527
Retrospective Review of Gastrointestinal System Endoscopy Procedures
An observational study of Endoscopy and Colonoscopy, run by Istanbul Sultanbeyli State Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Endoscopy, Colonoscopy, Gastroscopy
- How many people
- 15,448 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (over 18 years old)
- Patients who have undergone the procedure in our endoscopy unit
Who cannot join
- Under 18 years old
- Patients whose information cannot be accessed in the system records.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sultanbeyli State Hospital
Istanbul, 34935
About this study
The aim of the study is retrospectively evaluating all features of endoscopic and pathological diagnoses of cases who underwent upper and lower gastrointestinal endoscopy.
Read the 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.
- Conditions
- Endoscopy, Colonoscopy, Gastroscopy, Colonic Polyps, Endoscopy, Digestive System, Gastrointestinal Neoplasms
- Medical subject headings
- Colonic Polyps, Gastrointestinal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age distribution of patients in endoscopic procedures and histopathological examinations
Measured: During 3 months (retrospective endoscopy data review)
Gender
Sex distribution of patients in endoscopic procedures and histopathological examinations
Measured: During 3 months (retrospective endoscopy data review)
Type of endoscopy
Number of each endoscopy, Type (esophagogastroduodenoscopy, colonoscopy, rectosigmoidoscopy)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: During 3 months (retrospective endoscopy data review)
Non-neoplastic biopsy results
The patients with non-neoplastic biopsy results / the total patients
Measured: 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
Measured: During 3 months (retrospective endoscopy data review)
Prevalence of advanced neoplasia
The patients with advanced neoplasia / the total patients
Measured: 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
Measured: During 3 months (retrospective endoscopy data review)
Completeness rate of the procedures
The number of completed procedures / total number of procedures
Measured: During 3 months (retrospective endoscopy data review)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start11 Jun 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sultanbeyli State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammer Ergenç, MD, Istanbul Sultanbeyli State Hospital
- Investigators
- Muhammer Ergenç, MD, Principal investigator, Istanbul Sultanbeyli State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012527
- Sponsor's protocol ID
- 2021s01
- Acronym
- RRGIE
- Status last verified
- Oct 2021
- First submitted
- 15 Jul 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Gastrointestinal System Endoscopy Procedures
- ClinicalTrials.gov ID
- NCT05012527
- Acronym / sponsor ID
- RRGIE / 2021s01
- Conditions
- Endoscopy, Colonoscopy, Gastroscopy, Colonic Polyps, Endoscopy, Digestive System, Gastrointestinal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,448 participants (actual)
- Lead sponsor
- Istanbul Sultanbeyli State HospitalOther government
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is retrospectively evaluating all features of endoscopic and pathological diagnoses of cases who underwent upper and lower gastrointestinal endoscopy.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients (over 18 years old)
- Patients who have undergone the procedure in our endoscopy unit
Key exclusion criteria (2 listed)
- Under 18 years old
- Patients whose information cannot be accessed in the system records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age
Time frame: During 3 months (retrospective endoscopy data review)
Age distribution of patients in endoscopic procedures and histopathological examinations
Gender
Time frame: During 3 months (retrospective endoscopy data review)
Sex distribution of patients in endoscopic procedures and histopathological examinations
Type of endoscopy
Time frame: During 3 months (retrospective endoscopy data review)
Number of each endoscopy, Type (esophagogastroduodenoscopy, colonoscopy, rectosigmoidoscopy)
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)
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)
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
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
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
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)
Non-neoplastic biopsy results
Time frame: During 3 months (retrospective endoscopy data review)
The patients with non-neoplastic biopsy results / the total patients
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
Prevalence of advanced neoplasia
Time frame: During 3 months (retrospective endoscopy data review)
The patients with advanced neoplasia / the total patients
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
Completeness rate of the procedures
Time frame: During 3 months (retrospective endoscopy data review)
The number of completed procedures / total number of procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Endoscopy
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammer Ergenç, MD principal investigator
Istanbul Sultanbeyli State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy and Colonoscopy, run by Istanbul Sultanbeyli State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: During 3 months (retrospective endoscopy data review)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.