Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT07295405
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Water Temperature and Bowel Cleansing Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of bowel preparation', 'timeFrame': '01.02.2025-01.07.2025', 'description': 'The quality of bowel preparation will be assessed using the Boston Bowel Preparation Scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Bowel Preparation', 'Water Temperature', 'Boston Bowel Preparation Scale'], 'conditions': ['Colonoscopy (Procedure)']}, 'referencesModule': {'references': [{'pmid': '37077514', 'type': 'RESULT', 'citation': 'Shahini E, Sinagra E, Vitello A, Ranaldo R, Contaldo A, Facciorusso A, Maida M. Factors affecting the quality of bowel preparation for colonoscopy in hard-to-prepare patients: Evidence from the literature. World J Gastroenterol. 2023 Mar 21;29(11):1685-1707. doi: 10.3748/wjg.v29.i11.1685.'}]}, 'descriptionModule': {'briefSummary': 'Observational study The aim of this observational study is to investigate the effect of water temperature used during pre-colonoscopy bowel preparation on the quality of bowel cleansing. The primary research question to be addressed is as follows: Which water temperature results in better bowel cleansing quality? For this purpose, patients will be divided into two groups based on the use of warm water or cold water, and the quality of bowel preparation will be compared between the groups.', 'detailedDescription': 'The aim of this observational study is to investigate the effect of water temperature used during pre-colonoscopy bowel preparation on the quality of bowel cleansing. The primary research question to be addressed is as follows: Which water temperature results in better bowel cleansing quality? For this purpose, patients will be divided into two groups based on the use of warm water or cold water, and the quality of bowel preparation will be compared between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted to the general surgery endoscopy clinic of a tertiary-care hospital for colonoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients aged ≥ 18 years undergoing elective colonoscopy\n\nAbility to provide informed consent\n\nPlanned bowel preparation using water-based regimens\n\nNo contraindication to warm or cold water intake\n\nExclusion Criteria:\n\n* Emergency colonoscopy\n\nHistory of inflammatory bowel disease\n\nPrior colorectal surgery\n\nSevere heart failure, renal failure, or electrolyte imbalance\n\nPregnancy\n\nInability to complete bowel preparation protocol\n\nUse of additional laxatives outside the study protocol'}, 'identificationModule': {'nctId': 'NCT07295405', 'briefTitle': 'Water Temperature and Bowel Cleansing Quality', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Effect of Water Temperature on Bowel Cleansing Quality: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Bakırkoy Sadi konuk trials'}}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nurettin Şahin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All study data will be retained by the principal investigator and may be shared when required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant General Surgeon', 'investigatorFullName': 'Nurettin Şahin', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}