- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367373
Impact of the Four Seasons on Bowel Cleansing Quality Prior to Colonoscopy (SEASON-BCQ)
Patients scheduled to undergo elective colonoscopy will be evaluated in this observational study. No additional medications, interventions, or diagnostic procedures beyond standard clinical practice will be administered. The primary objective of the study is to investigate whether the quality of bowel preparation prior to colonoscopy varies according to seasonal differences.
Bowel cleansing quality will be assessed during the colonoscopy procedure using standard evaluation criteria. The quality of bowel preparation will be compared across different seasons to determine the potential impact of seasonal variation on bowel cleansing adequacy prior to elective colonoscopy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as an observational analysis of patients undergoing elective colonoscopy. All participants will receive standard bowel preparation according to routine clinical practice, and no additional medications, interventions, or diagnostic tests will be introduced as part of the study protocol.
The primary aim of the study is to evaluate whether seasonal variation influences the quality of bowel preparation prior to colonoscopy. Adequate bowel cleansing is a critical factor affecting diagnostic accuracy, procedural efficiency, and patient outcomes during colonoscopy. Environmental factors, including seasonal changes, may influence patient compliance, hydration status, and dietary habits, which could potentially affect bowel preparation quality.
Bowel cleansing quality will be assessed during the colonoscopy procedure using established bowel preparation assessment criteria. Patients will be categorized according to the season in which the colonoscopy is performed, and bowel preparation quality will be compared among these seasonal groups.
The findings of this study are expected to provide insight into the potential impact of seasonal variation on bowel preparation quality and may contribute to optimizing colonoscopy preparation strategies in clinical practice.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34147
- Bakırköy Dr. Sadi Konuk Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged between 18 and 90 years
- Patients scheduled for elective colonoscopy
Exclusion Criteria:
- Patients younger than 18 years or older than 90 years
- Patients scheduled for emergency colonoscopy
- Patients with colonic obstruction
- Patients with chronic kidney disease
- Patients with a history of abdominal surgery involving the stomach, duodenum, small intestine, or colon
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Spring Group
Patients undergoing elective colonoscopy during the spring season.
Bowel preparation quality will be assessed during routine colonoscopy without any additional intervention, medication, or diagnostic procedure beyond standard clinical practice.
|
This is an observational and non-interventional study.
No additional medications, diagnostic tests, or procedures are administered to the patients beyond routine clinical practice.
The intervention consists solely of assessing bowel preparation quality during routinely performed elective colonoscopy procedures and evaluating its association with seasonal variation.
|
|
Summer Group
Patients undergoing elective colonoscopy during the summer season.
Bowel preparation quality will be assessed during routine colonoscopy without any additional intervention, medication, or diagnostic procedure beyond standard clinical practice.
|
This is an observational and non-interventional study.
No additional medications, diagnostic tests, or procedures are administered to the patients beyond routine clinical practice.
The intervention consists solely of assessing bowel preparation quality during routinely performed elective colonoscopy procedures and evaluating its association with seasonal variation.
|
|
Autumn Group
Patients undergoing elective colonoscopy during the autumn season.
Bowel preparation quality will be assessed during routine colonoscopy without any additional intervention, medication, or diagnostic procedure beyond standard clinical practice.
|
This is an observational and non-interventional study.
No additional medications, diagnostic tests, or procedures are administered to the patients beyond routine clinical practice.
The intervention consists solely of assessing bowel preparation quality during routinely performed elective colonoscopy procedures and evaluating its association with seasonal variation.
|
|
Winter Group
Patients undergoing elective colonoscopy during the winter season.
Bowel preparation quality will be assessed during routine colonoscopy without any additional intervention, medication, or diagnostic procedure beyond standard clinical practice.
|
This is an observational and non-interventional study.
No additional medications, diagnostic tests, or procedures are administered to the patients beyond routine clinical practice.
The intervention consists solely of assessing bowel preparation quality during routinely performed elective colonoscopy procedures and evaluating its association with seasonal variation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bowel Preparation Quality During Elective Colonoscopy
Time Frame: During the colonoscopy procedure
|
Bowel preparation quality assessed during elective colonoscopy using the Boston Bowel Preparation Scale (BBPS), which ranges from 0 to 9, with higher scores indicating better bowel cleansing quality.
Bowel preparation quality scores will be compared across different seasons.
|
During the colonoscopy procedure
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BSK_BowelPrep_Seasonal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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