Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-23 @ 8:30 PM
Study NCT ID:
NCT01762735
Status:
UNKNOWN
Last Update Posted:
2013-02-12
First Post:
2013-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-10', 'studyFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of the cecal intubation within 15 min(%)', 'timeFrame': 'This will be calculated after the completion of the whole trial,which is about 2 months'}], 'secondaryOutcomes': [{'measure': 'The cecal intubation time(min);', 'timeFrame': 'This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length'}, {'measure': 'The time to reach the splenic flexure(min)', 'timeFrame': 'This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length'}, {'measure': 'VAS abdominal pain score', 'timeFrame': 'Data collected usually within 10minutes post procedure'}, {'measure': 'The frequency of the colonoscope shortening maneuver while advancing the colonoscope', 'timeFrame': 'This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.'}, {'measure': 'Length of colonoscope at time of cecal intubation(cm)', 'timeFrame': 'This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.'}, {'measure': 'Volume of water used during water colonoscopy(ml)', 'timeFrame': 'This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.'}, {'measure': 'General data of the patients recruited-age', 'timeFrame': 'Data collected usually within 10minutes post procedure .'}, {'measure': 'General data of the patients recruited-gender', 'timeFrame': 'Data collected usually within 10minutes post procedure .'}, {'measure': 'General data of the patients recruited-BMI', 'timeFrame': 'Data collected usually within 10minutes post procedure .'}, {'measure': 'General data of the patients recruited-abdominal or pelvic surgery history', 'timeFrame': 'Data collected usually within 10minutes post procedure .'}, {'measure': 'General data of the patients recruited-bowel preparation', 'timeFrame': 'Data collected usually within 10minutes post procedure .'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colon Disease', 'Rectal Disease', 'Pain']}, 'descriptionModule': {'briefSummary': "Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.", 'detailedDescription': 'Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.\n\nUp to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnostic colonoscopy;\n* Subjets able to provide informed consent\n\nExclusion Criteria:\n\n* Prior partial or complete colectomy;\n* Patients who decline to participate;\n* Patients with poor bowel preparation;\n* Contraindications of the colonoscopy'}, 'identificationModule': {'nctId': 'NCT01762735', 'briefTitle': 'Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners', 'orgStudyIdInfo': {'id': 'WIC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Air insufflation colonoscopy', 'description': 'Air insufflation colonoscopy is the conventional colonoscopy,which is inflating air to help searching the bowel cavity while advancing the colonoscope until reaching the cecum.All the patients were examined without sedation during the whole procedure.', 'interventionNames': ['Other: Air insufflation']}, {'type': 'EXPERIMENTAL', 'label': 'Water injection colonoscopy', 'description': 'Water injection colonoscopy : Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the caecum .All the patients were examined without sedation during the whole procedure.', 'interventionNames': ['Other: Water injection']}], 'interventions': [{'name': 'Air insufflation', 'type': 'OTHER', 'description': 'Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.', 'armGroupLabels': ['Air insufflation colonoscopy']}, {'name': 'Water injection', 'type': 'OTHER', 'description': 'Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum.', 'armGroupLabels': ['Water injection colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youlin Yang, M.D.', 'role': 'CONTACT', 'email': 'dr.yangylin@163.com', 'phone': '8613604809322'}, {'name': 'Xiaobing Wang, Master', 'role': 'CONTACT', 'email': 'wxbangel@sina.com', 'phone': '8613936135056'}, {'name': 'Youlin Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Youlin Yang, M.D.', 'role': 'CONTACT', 'email': 'dr.yangylin@163.com', 'phone': '8613604809322'}, {'name': 'Xiaobing Wang, Master', 'role': 'CONTACT', 'email': 'wxbangel@sina.com', 'phone': '8613936135056'}], 'overallOfficials': [{'name': 'Youlin Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Youlin Yang ,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Youlin Yang ,MD', 'investigatorAffiliation': 'First Affiliated Hospital of Harbin Medical University'}}}}