Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 3:58 AM
Study NCT ID:
NCT04383132
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Abdominal Binder Use During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'beslengoksoy@gmail.com', 'phone': '05349530112', 'title': 'Dr. Beslen Göksoy', 'organization': 'Şehit Prof. Dr. İlhan Varank Eğitim Ve Araştırma Hastanesi'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Time from the start of the colonoscopy until the patient's discharge, approximately 1-2 hours", 'eventGroups': [{'id': 'EG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 0, 'seriousNumAtRisk': 173, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 0, 'seriousNumAtRisk': 173, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Cecal Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'classes': [{'categories': [{'measurements': [{'value': '240', 'spread': '110', 'groupId': 'OG000'}, {'value': '250', 'spread': '115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.388', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Independent t-test was used to compare mean CIT between two groups. The statistical significance level was accepted as p\\<0.05', 'groupDescription': 'In sample size calculation, CIT and SD were used. It was found that 326 patients (163 per group) were required to detect a 60-second difference in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. The frequency of the auxiliary maneuvers was calculated that 324 patients were required for a 20% reduction in the auxiliary maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients was expanded by 5%, and a total of 346 patients, were included in the study.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes', 'description': 'Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum', 'unitOfMeasure': 'sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 patients were excluded from analysis CIT and CIL because the incompleted procedure (intervention group n 4, sham group n 5). Because the procedure must be completed for CIT and CIL analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Required Ancillary Maneuvers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "For the comparison of ancillary maneuvers Pearson chi-square test, Fisher's exact test, and Fisher-Freeman-Halton exact test were used.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes', 'description': 'Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Cecal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'spread': '18', 'groupId': 'OG000'}, {'value': '88.5', 'spread': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.487', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Independent t-test was used to compare mean CIL between two groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes', 'description': 'The length of the colonoscope required to reach the cecum from the anus will be measured', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 patients were excluded from analysis CIT and CIL because the incompleted procedure (intervention group n 4, sham group n 5). Because the procedure must be completed for CIT and CIL analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Completed the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.822', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes', 'description': 'Dichotomous outcome indicating if the procedure was incomplete or complete.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes', 'description': 'Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Pain and Comfort Level at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'classes': [{'title': 'VAS score', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'patient satisfaction score', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes', 'description': 'Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" =1 (min) and "worst pain"=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between "very unsatisfied" =1 (min) and "very satisfied"=5 (max) )', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Colonoscopy Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'classes': [{'categories': [{'title': 'Polyps', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}, {'title': 'Diverticulosis', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': 'No mucosal pathology', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'IBD or colitis', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'colon cancer', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.184', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes', 'description': 'Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'FG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'BG001', 'title': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure\n\nAbdominal Binder: abdominal binder is a kind of elastic abdominal compression device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.53', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '52.57', 'spread': '12.41', 'groupId': 'BG001'}, {'value': '51.55', 'spread': '12.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.79', 'spread': '5.02', 'groupId': 'BG000'}, {'value': '29.62', 'spread': '5.54', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'waist circumference (WC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '102.33', 'spread': '10.67', 'groupId': 'BG000'}, {'value': '103.26', 'spread': '11.84', 'groupId': 'BG001'}, {'value': '102.8', 'spread': '11.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-19', 'size': 560336, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-09-27T18:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2020-05-04', 'resultsFirstSubmitDate': '2020-09-27', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-19', 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Cecal Intubation Time', 'timeFrame': 'During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes', 'description': 'Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Required Ancillary Maneuvers', 'timeFrame': 'During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes', 'description': 'Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.'}, {'measure': 'Length of Cecal Intubation', 'timeFrame': 'From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes', 'description': 'The length of the colonoscope required to reach the cecum from the anus will be measured'}, {'measure': 'Number of Participants Who Completed the Procedure', 'timeFrame': 'During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes', 'description': 'Dichotomous outcome indicating if the procedure was incomplete or complete.'}, {'measure': 'Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug', 'timeFrame': 'During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes', 'description': 'Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy'}, {'measure': 'Patient Pain and Comfort Level at Discharge', 'timeFrame': 'At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes', 'description': 'Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" =1 (min) and "worst pain"=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between "very unsatisfied" =1 (min) and "very satisfied"=5 (max) )'}, {'measure': 'Number of Participants According to Colonoscopy Findings', 'timeFrame': 'During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes', 'description': 'Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal binder', 'colonoscopy', 'loop'], 'conditions': ['Performance and Tolerance of Colonoscopy']}, 'descriptionModule': {'briefSummary': 'Colonoscopy is considered the primary screening test for colorectal cancer screening worldwide. For technical difficulties previously experienced during colonoscopy, especially loop of the colonoscopy device in the colon, many solution methods have been developed and applied (manual pressure and position change, etc.). Although these methods are partially successful, there is no consensus on the optimum solution method. Few studies in the literature have investigated the use of corset during colonoscopy and conflicting results have been reported. In this study, elastic abdominal corset or false corset will be used during colonoscopy. Indeed, the investigators aim to determine whether this method is effective and safe with their own results and contribute to the literature. The primary outcome of this study will be the cecal intubation time. Secondary outcomes include manual pressure and position change during the procedure, length of cecal intubation (length of colonoscope required to reach the cecum from the anus), colonoscopy completion rate, additional anesthesia and / or analgesic requirement, patient pain and comfort level and colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBetween the ages of 18 - 90 Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.\n\nParticipants with ASA I-III (American Society of Anesthesiologists Class III)\n\nExclusion Criteria:\n\nPrevious colon resection History of intra-abdominal malignancy Known anesthetic or analgesic drugs allergy Multiple planned procedures (e.g.bidirectional endoscopy) Pregnancy Active inflammatory bowel disease A history of intraabdominal malignancy History of cirrhosis or ascites Known ventral hernia'}, 'identificationModule': {'nctId': 'NCT04383132', 'briefTitle': 'Effectiveness of Abdominal Binder Use During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}, 'officialTitle': 'Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial', 'orgStudyIdInfo': {'id': 'Beslen-korse'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abdominal Binder Intervention Group', 'description': 'Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.', 'interventionNames': ['Device: Abdominal Binder']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure', 'interventionNames': ['Device: Abdominal Binder']}], 'interventions': [{'name': 'Abdominal Binder', 'type': 'DEVICE', 'description': 'abdominal binder is a kind of elastic abdominal compression device', 'armGroupLabels': ['Abdominal Binder Intervention Group', 'Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34785', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Beslen Göksoy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Beslen Goksoy', 'investigatorAffiliation': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}}}}