Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 3:18 PM
Study NCT ID:
NCT04311333
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2020-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endostomal Three-dimensional Ultrasonography for Parastomal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will be examined with endostomal three-dimensional ultrasonography, clinical examination and computerized tomography before undergoing laparotomy or laparoscopy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test characteristics', 'timeFrame': '≥ 1 year since stoma creation', 'description': 'Sensitivity, specificity, predictive values, likelihood ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parastomal hernia', 'Ultrasound', 'Ultrasonography', 'Endostomal', 'Intrastomal', 'Colostomy', 'Ileostomy'], 'conditions': ['Parastomal Hernia']}, 'referencesModule': {'references': [{'pmid': '20821218', 'type': 'BACKGROUND', 'citation': 'Gurmu A, Matthiessen P, Nilsson S, Pahlman L, Rutegard J, Gunnarsson U. The inter-observer reliability is very low at clinical examination of parastomal hernia. Int J Colorectal Dis. 2011 Jan;26(1):89-95. doi: 10.1007/s00384-010-1050-2. Epub 2010 Sep 7.'}, {'pmid': '21509751', 'type': 'BACKGROUND', 'citation': 'Gurmu A, Gunnarsson U, Strigard K. Imaging of parastomal hernia using three-dimensional intrastomal ultrasonography. Br J Surg. 2011 Jul;98(7):1026-9. doi: 10.1002/bjs.7505. Epub 2011 Apr 20.'}, {'pmid': '22772711', 'type': 'BACKGROUND', 'citation': 'Strigard K, Gurmu A, Nasvall P, Pahlman P, Gunnarsson U. Intrastomal 3D ultrasound; an inter- and intra-observer evaluation. Int J Colorectal Dis. 2013 Jan;28(1):43-7. doi: 10.1007/s00384-012-1526-3. Epub 2012 Jul 7.'}, {'pmid': '24986139', 'type': 'BACKGROUND', 'citation': 'Nasvall P, Wikner F, Gunnarsson U, Rutegard J, Strigard K. A comparison between intrastomal 3D ultrasonography, CT scanning and findings at surgery in patients with stomal complaints. Int J Colorectal Dis. 2014 Oct;29(10):1263-6. doi: 10.1007/s00384-014-1944-5. Epub 2014 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The intention is to examine the role of ultrasonographic examination inside intestinal stomas in diagnosing parastomal hernia. Patients with a stoma since at least one year back who are being scheduled for abdominal surgery will be examined for eligibility according to the selection criteria. Included patients will undergo routine clinical examination, endostomal ultrasonography and computerized tomography scan of the abdomen. Findings will be correlated to findings during surgery (gold standard). Values for sensitivity, specificity, predictive values and likelihood ratio will be calculated.', 'detailedDescription': 'Parastomal hernia (PSH) is one of the most common stoma complications, with an incidence of 30-50 % within just a couple of years of stoma creation. Surgical parastomal hernia repair is a morbid and complicated procedure, with a 30-day reoperation rate of 13 % and 30-day mortality rate of 6 % in population-based surveys. There is no established gold standard diagnostic modality. Routinely, patients are examined clinically in various positions with and without increased intra-abdominal pressure. It has been shown in previous studies that clinical examination has a very low inter-observer reliability. Computerized tomography is often performed in addition to clinical examination, but is not ideal in diagnosing PSH either, not only beacause of insufficient test characteristics but also since the examinations should ideally be performed with specific protocols, prone position and be reviewed by a dedicated radiologist. The risk of incorrectly diagnosing a PSH (false positive) is that patients might subsequently be exposed to complex and dangerous surgical interventions without any health benefit, while incorrectly ruling out a PSH (false negative) can cause the patient to have to live with potentially treatable symptoms, life-threatening bowel incarceration being the most severe potential complication.\n\nThus, improved diagnostic accuracy is required. A method that has been developed within our research group is endostomal tree-dimensional ultrasonography, which has preliminarily proven to be approximately as sensitive as CT, with a markedly higher specificity. A larger and less selected study needs to be conducted in order to reliably calculate test characteristics, predictive values and likelihood ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End colostomy or end ileostomy since ≥ 1 year\n* Planned for laparotomy or laparoscopy\n* Age ≥ 18\n* Speaks and reads Swedish language\n* Informed consent\n\nExclusion Criteria:\n\n* Known parastomal hernia only indication for laparotomy or laparoscopy'}, 'identificationModule': {'nctId': 'NCT04311333', 'acronym': 'CTULOP', 'briefTitle': 'Endostomal Three-dimensional Ultrasonography for Parastomal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Endostomal Three-dimensional Ultrasonography Compared to Clinical Examination, Computerized Tomography and Intraoperative Findings for Parastomal Hernia Diagnosis', 'orgStudyIdInfo': {'id': 'CTULOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All patients', 'description': 'All patients undergo endostomal three-dimensional ultrasonography, computerized tomography, clinical examination and laparotomy/laparoscopy.\n\nAt all the respective examinations, the presence of a parastomal hernia as well as hernia location and size is evaluated.', 'interventionNames': ['Diagnostic Test: Endostomal three-dimensional ultrasonography', 'Diagnostic Test: Computerized tomography of the abdomen', 'Diagnostic Test: Clinical examination', 'Diagnostic Test: Evaluation at laparotomy/laparoscopy']}], 'interventions': [{'name': 'Endostomal three-dimensional ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Examination with rectal probe enclosed by water-filled balloon. Rectal mode. Dynamic examination in different positions with and without increased intra-abdominal pressure.', 'armGroupLabels': ['All patients']}, {'name': 'Computerized tomography of the abdomen', 'type': 'DIAGNOSTIC_TEST', 'description': 'Supine position, without increased intra-abdominal pressure. Experienced radiologist interprets the examination.\n\nIf adequate examination has already been performed within the last 10 months, these images will be used and the patient will thus not undergo computerized tomography within the study.', 'armGroupLabels': ['All patients']}, {'name': 'Clinical examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be clinically examined with inspection and palpation in supine and erect position with and without increased intra-abdominal pressure.', 'armGroupLabels': ['All patients']}, {'name': 'Evaluation at laparotomy/laparoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'During laparotomy or laparoscopy, inspection and/or palpation of the stoma at the abdominal wall orifice is performed.', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '971 80', 'city': 'Luleå', 'state': 'Norrbotten County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Johan Nyman, M.D.', 'role': 'CONTACT', 'email': 'johan.nyman@umu.se', 'phone': '+46727436345'}, {'name': 'Karin Strigård, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'karin.strigard@umu.se', 'phone': '+46907864687'}], 'facility': 'Sunderby Hospital', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'zip': '152 86', 'city': 'Södertälje', 'state': 'Stockholm County', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Fredrik Brännström, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'fredrikbrannstrom@yahoo.se', 'phone': '+46855024000'}], 'facility': 'Södertälje Hospital', 'geoPoint': {'lat': 59.19554, 'lon': 17.62525}}, {'zip': '907 37', 'city': 'Umeå', 'state': 'Västerbotten County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Johan Nyman, M.D.', 'role': 'CONTACT', 'email': 'johan.nyman@umu.se', 'phone': '+46727436345'}, {'name': 'Karin Strigård, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'karin.strigard@umu.se', 'phone': '+46907864687'}], 'facility': 'University Hospital of Umeå', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Johan Nyman, M.D.', 'role': 'CONTACT', 'email': 'johan.nyman@umu.se', 'phone': '(+46)90 786 46 87'}, {'name': 'Karin Strigård, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'karin.strigård@umu.se', 'phone': '(+46)90 786 46 87'}], 'overallOfficials': [{'name': 'Karin Strigård', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}