Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-26 @ 12:08 AM
Study NCT ID:
NCT03954561
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2017-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2017-06-10', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cecal intubation time', 'timeFrame': 'through study completion, average 15 minutes', 'description': 'the time when the colonoscope is inserted from the anus to the cecum.'}], 'secondaryOutcomes': [{'measure': 'proportion of patients requiring abdominal compression by an assistant', 'timeFrame': 'through study completion, average 15 minutes', 'description': 'proportion of patients requiring abdominal compression by an assistant'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'cecal intubation time'], 'conditions': ['Colonic Polyp', 'Colonic Adenoma']}, 'referencesModule': {'references': [{'pmid': '12014719', 'type': 'BACKGROUND', 'citation': 'Rex DK, Goodwine BW. Method of colonoscopy in 42 consecutive patients presenting after prior incomplete colonoscopy. Am J Gastroenterol. 2002 May;97(5):1148-51. doi: 10.1111/j.1572-0241.2002.05681.x.'}, {'pmid': '12048623', 'type': 'BACKGROUND', 'citation': 'Shah SG, Brooker JC, Thapar C, Williams CB, Saunders BP. Patient pain during colonoscopy: an analysis using real-time magnetic endoscope imaging. Endoscopy. 2002 Jun;34(6):435-40. doi: 10.1055/s-2002-31995.'}, {'pmid': '25071360', 'type': 'BACKGROUND', 'citation': 'Herreros de Tejada A, Gimenez-Alvira L, Van den Brule E, Sanchez-Yuste R, Matallanos P, Blazquez E, Calleja JL, Abreu LE. Severe splenic rupture after colorectal endoscopic submucosal dissection. World J Gastroenterol. 2014 Jul 28;20(28):9618-20. doi: 10.3748/wjg.v20.i28.9618.'}, {'pmid': '2032597', 'type': 'BACKGROUND', 'citation': 'Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. doi: 10.1016/s0016-5107(91)70673-1.'}, {'pmid': '8503077', 'type': 'BACKGROUND', 'citation': 'Church JM. Ancillary colonoscope insertion techniques. An evaluation. Surg Endosc. 1993 May-Jun;7(3):191-3. doi: 10.1007/BF00594106.'}, {'pmid': '10805853', 'type': 'BACKGROUND', 'citation': 'Catalano F, Catanzaro R, Branciforte G, Bentivegna CF, Cipolla R, Brogna A, Sala LO, Migliore G, Paternuosto M. Colonoscopy technique with an external straightener. Gastrointest Endosc. 2000 May;51(5):600-4. doi: 10.1016/s0016-5107(00)70301-4.'}, {'pmid': '18251143', 'type': 'BACKGROUND', 'citation': 'Tsutsumi S, Fukushima H, Kuwano H. Colonoscopy using an abdominal bandage. Hepatogastroenterology. 2007 Oct-Nov;54(79):1983-4.'}, {'pmid': '21955429', 'type': 'BACKGROUND', 'citation': 'Dechene A, Jochum C, Bechmann LP, Windeck S, Gerken G, Canbay A, Zopf T. Magnetic endoscopic imaging saves abdominal compression and patient pain in routine colonoscopies. J Dig Dis. 2011 Oct;12(5):364-70. doi: 10.1111/j.1751-2980.2011.00524.x.'}, {'pmid': '19582577', 'type': 'BACKGROUND', 'citation': 'Hsieh YH, Tseng KC, Chou AL. Patient self-administered abdominal pressure to reduce loop formation during minimally sedated colonoscopy. Dig Dis Sci. 2010 May;55(5):1429-33. doi: 10.1007/s10620-009-0876-3. Epub 2009 Jul 7.'}, {'pmid': '22898423', 'type': 'BACKGROUND', 'citation': 'Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.'}, {'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': '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. Epub 2014 Sep 26.'}, {'pmid': '27922025', 'type': 'BACKGROUND', 'citation': 'Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.'}, {'pmid': '27988288', 'type': 'BACKGROUND', 'citation': 'Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.'}, {'pmid': '25196871', 'type': 'BACKGROUND', 'citation': 'Rex DK. Water exchange vs. water immersion during colonoscope insertion. Am J Gastroenterol. 2014 Sep;109(9):1401-3. doi: 10.1038/ajg.2014.235.'}, {'pmid': '23805397', 'type': 'BACKGROUND', 'citation': 'Leung JW, Thai A, Yen A, Ward G, Abramyan O, Lee J, Smith B, Leung F. Magnetic endoscope imaging (ScopeGuide) elucidates the mechanism of action of the pain-alleviating impact of water exchange colonoscopy - attenuation of loop formation. J Interv Gastroenterol. 2012 Jul;2(3):142-146. doi: 10.4161/jig.23738. Epub 2012 Jul 1.'}, {'pmid': '18805238', 'type': 'BACKGROUND', 'citation': "Kudo Se, Lambert R, Allen JI, Fujii H, Fujii T, Kashida H, Matsuda T, Mori M, Saito H, Shimoda T, Tanaka S, Watanabe H, Sung JJ, Feld AD, Inadomi JM, O'Brien MJ, Lieberman DA, Ransohoff DF, Soetikno RM, Triadafilopoulos G, Zauber A, Teixeira CR, Rey JF, Jaramillo E, Rubio CA, Van Gossum A, Jung M, Vieth M, Jass JR, Hurlstone PD. Nonpolypoid neoplastic lesions of the colorectal mucosa. Gastrointest Endosc. 2008 Oct;68(4 Suppl):S3-47. doi: 10.1016/j.gie.2008.07.052. No abstract available."}, {'pmid': '14652541', 'type': 'BACKGROUND', 'citation': 'The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc. 2003 Dec;58(6 Suppl):S3-43. doi: 10.1016/s0016-5107(03)02159-x. No abstract available.'}, {'pmid': '19136102', 'type': 'BACKGROUND', 'citation': 'Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.'}]}, 'descriptionModule': {'briefSummary': "Loop formation is the most frequent cause of cecal intubation failure during colonoscopy. To reduce the loop formation, external abdominal pressure is widely used and proved to be helpful. Properly applied pressure can also decrease patients discomfort and shorten the cecal intubation time.\n\nThe loop formation during water exchange is less severe as compared with during air insufflation and can be reduced quite readily. Traditionally an assistant is not asked to administer abdominal compression until the endoscopist has struggled for some time and failed to reduce the loops by withdrawal. The colonoscopist can administer the abdominal compression whenever the scope is not advancing smoothly, probably in the early stage of loop formation. We test the hypothesis that colonoscopist administered abdominal compression to remove loops in their early stage of formation hastens cecal intubation.\n\nA total of 120patients will be randomized in a 1:1 ratio (n=60 per group). When the tip of the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the scope will be implemented. If looping persists, abdominal compression will be applied. In the endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will apply the compression with his right hand and counter the pressure by pushing the back of the patient with his left forearm with the colonoscope in his left hand. The compression will be administered at left lower quadrant when the scope is in the sigmoid colon and at left lower quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or ascending colon. If the formation of loop cannot be overcome, an assistant will apply the abdominal compression instead. In the assistant-administered abdominal compression (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is formed. The assistant will apply the compression at the left lower quadrant initially, but quickly shift to other parts as needed depending on the tip location of colonoscope. If manual compressions fail, then the patients' position will be changed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In the Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.\n* Patients who undergo WE colonoscopy performed by the two endoscopists (YHH and CWT) at the endoscopic suite will be included.\n\nExclusion Criteria:\n\n* Included patient declined to give consent,\n* age \\<20 years old,\n* age \\>80 years old,\n* previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (BMI ≥ 35).'}, 'identificationModule': {'nctId': 'NCT03954561', 'briefTitle': 'Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Dalin Tzu Chi General Hospital'}, 'officialTitle': 'Abdominal Compression Administered Early by the Colonoscopist Shortened Insertion Time of Water Exchange Colonoscopy', 'orgStudyIdInfo': {'id': 'A10601001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'endoscopist group', 'description': 'endoscopist-administered abdominal compression group', 'interventionNames': ['Procedure: endoscopist-administered abdominal compression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'assistant group', 'description': 'assistant-administered abdominal compression group', 'interventionNames': ['Procedure: assistant-administered abdominal compression']}], 'interventions': [{'name': 'endoscopist-administered abdominal compression', 'type': 'PROCEDURE', 'description': 'The endoscopist administers abdominal compression when loop formation encountered.', 'armGroupLabels': ['endoscopist group']}, {'name': 'assistant-administered abdominal compression', 'type': 'PROCEDURE', 'description': 'A assistant administers abdominal compression when loop formation encountered.', 'armGroupLabels': ['assistant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '622', 'city': 'Chiayi City', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}], 'overallOfficials': [{'name': 'Yu-Hsi Hsieh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buddhist Dalin Tzu Chi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalin Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Gastroenterology Endoscopy Suite', 'investigatorFullName': 'Yu-Hsi hsieh', 'investigatorAffiliation': 'Dalin Tzu Chi General Hospital'}}}}