Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT00909116
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2009-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Multicenter Prospective Transtar Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D020047', 'term': 'Rectocele'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2012-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2009-05-26', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in constipation symptoms measured by KESS score', 'timeFrame': 'preoperative, and at 12 months post-op'}], 'secondaryOutcomes': [{'measure': 'Changes in patients symptoms measured by Incontinence score and ODS Score, QoL measures with EQ5D and PAC-QoL', 'timeFrame': 'preoperative, at 6 weeks and 12 months post-op'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ODS', 'chronic constipation', 'internal rectal prolapse', 'rectocele', 'Stapled Transanal Rectal Resection', 'Contour Transtar', 'STARR'], 'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '18403378', 'type': 'BACKGROUND', 'citation': 'Schwandner O, Stuto A, Jayne D, Lenisa L, Pigot F, Tuech JJ, Scherer R, Nugent K, Corbisier F, Basany EE, Hetzer FH. Decision-making algorithm for the STARR procedure in obstructed defecation syndrome: position statement of the group of STARR Pioneers. Surg Innov. 2008 Jun;15(2):105-9. doi: 10.1177/1553350608316684. Epub 2008 Apr 9.'}, {'pmid': '18654789', 'type': 'BACKGROUND', 'citation': 'Renzi A, Talento P, Giardiello C, Angelone G, Izzo D, Di Sarno G. Stapled trans-anal rectal resection (STARR) by a new dedicated device for the surgical treatment of obstructed defaecation syndrome caused by rectal intussusception and rectocele: early results of a multicenter prospective study. Int J Colorectal Dis. 2008 Oct;23(10):999-1005. doi: 10.1007/s00384-008-0522-0. Epub 2008 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ODS is usually associated with internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of surgical techniques have been described with no one method having been assessed as a gold standard.', 'detailedDescription': 'A new surgical procedure - Transtar - has been introduced in Europe recently. The goal of this registry is to assess safety, effectiveness and patient quality of life, associated with Transtar for chronic constipation due to morphological changes, such as internal rectal prolapse and rectocele.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive male and female patients of at least 16 years with symptoms of chronic constipation due to ODS associated with anatomical changes, such as internal rectal prolapse and rectocele', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score\n* confirmed internal rectal prolapse or rectocele on dynamic defecography\n* adequate external sphincter on rectal digital examination.\n\nExclusion Criteria:\n\n* Subjects with any other surgical procedure than STARR for ODS\n* Subjects in whom STARR is not performed with the Contour Transtar stapler\n* Subjects with a physical or psychological condition which would impair participation in the registry.'}, 'identificationModule': {'nctId': 'NCT00909116', 'briefTitle': 'International Multicenter Prospective Transtar Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon Endo-Surgery (Europe) GmbH'}, 'officialTitle': 'International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)', 'orgStudyIdInfo': {'id': 'CME-08-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic constipation - ODS', 'description': 'Adult Patients with ODS', 'interventionNames': ['Procedure: Stapled Transanal Rectal Resection with Contour Transtar']}], 'interventions': [{'name': 'Stapled Transanal Rectal Resection with Contour Transtar', 'type': 'PROCEDURE', 'description': 'Transanal Stapling procedure - Stapled Transanal Rectal Resection', 'armGroupLabels': ['Chronic constipation - ODS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': "Andree D'Hoore", 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Goran Ribaric, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethicon Endo-Surgery (Europe) GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'via publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon Endo-Surgery (Europe) GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}