Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 8:21 AM
Study NCT ID:
NCT03160859
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'C537774', 'term': 'Anterior polar cataract 2'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'felix.leung@va.gov', 'phone': '818-891-7711', 'title': 'Felix W. Leung, M.D, Staff Gastroenterologist', 'phoneExt': '32520', 'organization': 'Veterans Administration Greater Los Angeles Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The limitations included: (1) subjects were mostly male Veterans, (2) colonoscopists were unblinded, (3) colonoscopist-assessed patient anxiety was subjective and not measured on a standardized anxiety scale.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and serious adverse event, were monitored for the total duration of the study, which was up to 30 days.', 'description': 'Our definition of Adverse or Serious Adverse Events does not differ from the clinicaltrials.gov definitions.\n\nAll colonoscopy procedures were routinely performed by gastroenterologists with at least 5 years of experience.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nControl: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 0, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nStudy method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Real Time Maximum Insertion Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nControl: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.'}, {'id': 'OG001', 'title': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nStudy method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Chi Square', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With No Insertion Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nControl: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.'}, {'id': 'OG001', 'title': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nStudy method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Proportion of patients who report no pain during insertion of the colonoscope.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insertion Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nControl: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.'}, {'id': 'OG001', 'title': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nStudy method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Time to cecum (clock display on monitor), faster insertion is a quality marker', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Colon Adenoma Detection Rate (ADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nControl: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.'}, {'id': 'OG001', 'title': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nStudy method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nControl: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.'}, {'id': 'FG001', 'title': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nStudy method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects will be selected from patients scheduled for colonoscopy as part of their routine care. Eligible subjects will be asked to sign the ICF. Control and study methods will be explained, and study subjects will undergo a questionnaire, physical examination, and unsedated colonoscopy with the standard (control) or study methods. Ineligible patients will be offered unsedated colonoscopy by standard method, outside the research study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nControl: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.'}, {'id': 'BG001', 'title': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.\n\nStudy method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Male and female veterans aged 50-80, inclusive.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All enrolled participants were United States Veterans', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All patients were US veterans scheduled for routine colonoscopy as part of their standard of care.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-14', 'size': 512212, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-11T14:59', 'hasProtocol': True}, {'date': '2017-08-14', 'size': 341568, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-12T17:01', 'hasProtocol': False}, {'date': '2019-12-16', 'size': 334533, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-02T15:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site. Control Method: Involves unsedated colonoscopy with water exchange. Residual air will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2017-05-12', 'resultsFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-17', 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real Time Maximum Insertion Pain', 'timeFrame': 'Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With No Insertion Pain', 'timeFrame': 'Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Proportion of patients who report no pain during insertion of the colonoscope.'}, {'measure': 'Insertion Time', 'timeFrame': 'Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Time to cecum (clock display on monitor), faster insertion is a quality marker'}, {'measure': 'Right Colon Adenoma Detection Rate (ADR)', 'timeFrame': 'Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour', 'description': 'Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['unsedated colonoscopy', 'water exchange colonoscopy', 'cap', 'colonoscopy pain'], 'conditions': ['Unsedated Colonoscopy', 'Water Exchange Colonoscopy', 'Cap', 'Colonoscopy Pain']}, 'referencesModule': {'references': [{'pmid': '4682941', 'type': 'BACKGROUND', 'citation': 'Wolff WI, Shinya H. Polypectomy via the fiberoptic colonoscope. Removal of neoplasms beyond reach of the sigmoidoscope. N Engl J Med. 1973 Feb 15;288(7):329-32. doi: 10.1056/NEJM197302152880701. No abstract available.'}, {'pmid': '19249764', 'type': 'BACKGROUND', 'citation': 'Leung FW. The case of unsedated screening colonoscopy in the United States. Gastrointest Endosc. 2009 Jun;69(7):1354-6. doi: 10.1016/j.gie.2008.12.234. Epub 2009 Feb 27. No abstract available.'}, {'pmid': '21160707', 'type': 'BACKGROUND', 'citation': 'Leung FW, Aljebreen AM, Brocchi E, Chang EB, Liao WC, Mizukami T, Schapiro M, Triantafyllou K. Sedation-risk-free colonoscopy for minimizing the burden of colorectal cancer screening. World J Gastrointest Endosc. 2010 Mar 16;2(3):81-9. doi: 10.4253/wjge.v2.i3.81.'}, {'pmid': '21686108', 'type': 'BACKGROUND', 'citation': 'Leung FW. Is there a place for sedationless colonoscopy? J Interv Gastroenterol. 2011 Jan;1(1):19-22. doi: 10.4161/jig.1.1.14592.'}, {'pmid': '8603544', 'type': 'BACKGROUND', 'citation': 'Cataldo PA. Colonoscopy without sedation. Dis Colon Rectum. 1996 Mar;39(3):257-61. doi: 10.1007/BF02049463.'}, {'pmid': '9649011', 'type': 'BACKGROUND', 'citation': 'Hoffman MS, Butler TW, Shaver T. Colonoscopy without sedation. J Clin Gastroenterol. 1998 Jun;26(4):279-82. doi: 10.1097/00004836-199806000-00013.'}, {'pmid': '10228251', 'type': 'BACKGROUND', 'citation': 'Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc. 1999 May;49(5):554-9. doi: 10.1016/s0016-5107(99)70381-0.'}, {'pmid': '15942439', 'type': 'BACKGROUND', 'citation': 'Subramanian S, Liangpunsakul S, Rex DK. Preprocedure patient values regarding sedation for colonoscopy. J Clin Gastroenterol. 2005 Jul;39(6):516-9. doi: 10.1097/01.mcg.0000165667.79530.44.'}, {'pmid': '10406249', 'type': 'BACKGROUND', 'citation': 'Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol. 1999 Jul;94(7):1862-5. doi: 10.1111/j.1572-0241.1999.01219.x.'}, {'pmid': '21686115', 'type': 'BACKGROUND', 'citation': "Leung FW. Patients' perspective - written testimonials from physician-patients and oral accounts presented by patients in person. J Interv Gastroenterol. 2011 Jan;1(1):45-46. doi: 10.4161/jig.1.1.14605. No abstract available."}, {'pmid': '17608779', 'type': 'BACKGROUND', 'citation': 'Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007 Nov;102(11):2401-10. doi: 10.1111/j.1572-0241.2007.01387.x. Epub 2007 Jun 29.'}, {'pmid': '18274901', 'type': 'BACKGROUND', 'citation': 'Leung FW. Unsedated colonoscopy introduced to ensure access is acceptable to a subgroup of veterans. Dig Dis Sci. 2008 Oct;53(10):2719-22. doi: 10.1007/s10620-007-0192-8. Epub 2008 Feb 15.'}, {'type': 'BACKGROUND', 'citation': 'Felix W. Leung, Hartley Cohen, Stanley K. Dea, Dennis M. Jensen, Thomas O. Kovacs, Gordon V. Ohning, Joseph R. Pisegna, Alireza Sedarat, Alan Sheinbaum, Timothy C. Simmons, Rebecca Slomovic, Brennan M. Spiegel, Mitchell J. Spirt, James Sul and Rabindra R. Watson. Scheduled unsedated colonoscopy - a novel tool for managing no shows due to lack of escorts required for conscious sedation. Gastrointestinal Endoscopy, 2014-05-01, Volume 79, Issue 5, Pages AB178-AB179'}, {'pmid': '11474385', 'type': 'BACKGROUND', 'citation': 'Terruzzi V, Meucci G, Radaelli F, Terreni N, Minoli G. Routine versus "on demand" sedation and analgesia for colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2001 Aug;54(2):169-74. doi: 10.1067/mge.2001.113923.'}, {'pmid': '20619405', 'type': 'BACKGROUND', 'citation': 'Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.'}, {'type': 'BACKGROUND', 'citation': 'Leung JW, Mann SK, Siao-Salera R, Canete W, Leung FW. The established and time-tested water exchange method in scheduled unsedated colonoscopy significantly enhanced patient-centered outcomes without prolonging procedural times - A RCT. J Interv Gastroenterol. 2013;3(1):7-11.'}, {'pmid': '24890443', 'type': 'BACKGROUND', 'citation': 'Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3.'}, {'pmid': '24218307', 'type': 'BACKGROUND', 'citation': 'Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11.'}, {'pmid': '25262100', 'type': 'BACKGROUND', 'citation': 'Cadoni S, Sanna S, Gallittu P, Argiolas M, Fanari V, Porcedda ML, Erriu M, Leung FW. A randomized, controlled trial comparing real-time insertion pain during colonoscopy confirmed water exchange to be superior to water immersion in enhancing patient comfort. Gastrointest Endosc. 2015 Mar;81(3):557-66. doi: 10.1016/j.gie.2014.07.029. 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Am J Gastroenterol. 2000 Oct;95(10):2784-7. doi: 10.1111/j.1572-0241.2000.03186.x.'}, {'pmid': '39053653', 'type': 'DERIVED', 'citation': 'Leung FW, Cheung R, Friedland S, Jacob N, Leung JW, Pan JY, Quan SY, Sul J, Yen AW, Jamgotchian N, Chen Y, Dixit V, Shaikh A, Elashoff D, Saha A, Wilhalme H. Prospective randomized controlled trial of water exchange plus cap versus water exchange colonoscopy in unsedated veterans. Gastrointest Endosc. 2025 Feb;101(2):402-413.e2. doi: 10.1016/j.gie.2024.07.010. Epub 2024 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.', 'detailedDescription': 'This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful.\n\nPatients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.\n\nControl Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.\n\nStudy method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:\n\n * diagnostic\n * surveillance (follow up of polyps)\n * screening (first-time) colonoscopy at participating sites\n * choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)\n\nExclusion Criteria:\n\n* decline to be randomized\n* unable to give consent or respond to questionnaires\n* history of colon surgery\n* active inflammatory bowel disease\n* lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)\n* therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)\n* proctosigmoidoscopy\n* bidirectional endoscopy\n* inadequate consumption of bowel preparation\n* known history of severe diverticulosis or diverticulitis\n* history of abdominal surgery previously requiring sedation for colonoscopy\n* current narcotic/anxiolytic medication use\n* prior unsuccessful experience with unsedated colonoscopy\n* emergent colonoscopy\n* evidence of colonic obstruction based on pre-colonoscopy clinical evaluation\n* current participation in other studies\n* medical condition that could increase the risk associated with colonoscopy\n\n * active cardiac\n * or pulmonary disease\n * or other serious disease\n* medical condition that would preclude a benefit from colonoscopic screening\n\n * cancer\n * or any terminal illness\n* prosthetic heart valve\n* anticoagulant therapy\n* nonmedical problems\n\n * psychiatric disorders\n * excessive use of alcohol\n* need for special precautions in performing colonoscopy\n\n * antibiotic prophylaxis\n* request of on demand sedation'}, 'identificationModule': {'nctId': 'NCT03160859', 'briefTitle': 'Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy', 'nctIdAliases': ['NCT03543124'], 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy', 'orgStudyIdInfo': {'id': 'GAST-015-16S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Method', 'description': 'One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.', 'interventionNames': ['Other: Control']}, {'type': 'OTHER', 'label': 'Study Method', 'description': 'The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.', 'interventionNames': ['Device: Study method']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'otherNames': ['Water exchange method'], 'description': 'Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.', 'armGroupLabels': ['Control Method']}, {'name': 'Study method', 'type': 'DEVICE', 'otherNames': ['Water exchange method plus cap'], 'description': 'Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.', 'armGroupLabels': ['Study Method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System, Palo Alto, CA', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95655', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'VA Northern California Health Care System, Mather, CA', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '91343', 'city': 'Sepulveda', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, Sepulveda, CA', 'geoPoint': {'lat': 34.16167, 'lon': -118.28285}}], 'overallOfficials': [{'name': 'Felix W. Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, Sepulveda, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'VA Northern California Health Care System', 'class': 'FED'}, {'name': 'VA Palo Alto Health Care System', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}