Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT05107505
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2021-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy
Sponsor:
Alexandra Hospital, Athens, Greece
Organization:
Study Overview
Official Title:
Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective observational study in order to:
1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
Detailed Description:
Unsuccessful preparation for lower gastrointestinal endoscopy is to date the main obstacle to a comprehensive examination and the main reason for its recurrence. It is also directly related to its diagnostic value.
The literature shows that the diet prior to colonoscopy, the time of assumption of the preparation and certain epidemiological and clinical characteristics of the patient can affect the outcome of the intestinal preparation for colonoscopy.
This seems that adequasy of colonoscopy affects a number of qualitative indicators of lower gastrointestinal endoscopy, such as the duration, the catheterization of the fundus of the cecum and the number of polyps found.
This is a prospective observational study in order to:
1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
With starting date:01/07/2021 and expiration date:30/06/2022 (duration: 12 months). All patients who come to the Gastroenterology Department of Alexandra Hospital for endoscopy of the lower digestive tract are eligible for the research protocol. Patients younger than 18 years old or patients who refuse to participate are excluded.
The study has 3 phases. Phase 0 entails the completion of a questionnaire that will include epidemiological, clinical and preparation-related data in all patients who undergoing colonoscopy at the Endoscopy Department. Phase I incorporates Completion of data related to the time of the examination, the result of the preparation (Boston Bowel Preparation Scale) as well as the findings of the endoscopic examination and phase II includes the statistical analysis of the data.
The literature shows that the diet prior to colonoscopy, the time of assumption of the preparation and certain epidemiological and clinical characteristics of the patient can affect the outcome of the intestinal preparation for colonoscopy.
This seems that adequasy of colonoscopy affects a number of qualitative indicators of lower gastrointestinal endoscopy, such as the duration, the catheterization of the fundus of the cecum and the number of polyps found.
This is a prospective observational study in order to:
1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
With starting date:01/07/2021 and expiration date:30/06/2022 (duration: 12 months). All patients who come to the Gastroenterology Department of Alexandra Hospital for endoscopy of the lower digestive tract are eligible for the research protocol. Patients younger than 18 years old or patients who refuse to participate are excluded.
The study has 3 phases. Phase 0 entails the completion of a questionnaire that will include epidemiological, clinical and preparation-related data in all patients who undergoing colonoscopy at the Endoscopy Department. Phase I incorporates Completion of data related to the time of the examination, the result of the preparation (Boston Bowel Preparation Scale) as well as the findings of the endoscopic examination and phase II includes the statistical analysis of the data.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: