Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT02971332
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2016-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Results of STARR With Contour Transtar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012005', 'term': 'Rectal Prolapse'}, {'id': 'D020047', 'term': 'Rectocele'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006547', 'term': 'Hernia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2016-11-20', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Defecatory aids', 'timeFrame': '6 months', 'description': 'the use of laxatives or digitation to defecate'}, {'measure': 'Defecatory aids', 'timeFrame': '5 years', 'description': 'the use of laxatives or digitation to defecate'}], 'primaryOutcomes': [{'measure': 'degree of constipation', 'timeFrame': '6 months', 'description': 'Cleveland Clinic Constipation Score'}, {'measure': 'degree of constipation', 'timeFrame': '5 years', 'description': 'Cleveland Clinic Constipation Score'}], 'secondaryOutcomes': [{'measure': 'Surgical Complications', 'timeFrame': '0-6 months', 'description': 'intraoperative and postoperative surgical complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rectal Prolapse', 'Rectocele', 'Intussusception of Rectum']}, 'referencesModule': {'references': [{'pmid': '28600694', 'type': 'DERIVED', 'citation': 'Mari FS, Pezzatini M, Gasparrini M, Antonio B. STARR with Contour Transtar for Obstructed Defecation Syndrome: Long-Term Results. World J Surg. 2017 Nov;41(11):2906-2911. doi: 10.1007/s00268-017-4084-6.'}]}, 'descriptionModule': {'briefSummary': 'Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study the investigators want to evaluate the long term results of Stapled Transanal Rectal Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with symptomatic ODS after failure of medical and dietary therapy and with the presence determined through cinedefecography of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception, in the absence of anal sphincter contractile deficiency', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ODS\n* presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception.\n\nExclusion Criteria:\n\n* anal sphincter contractile deficiency\n* previous rectal resection'}, 'identificationModule': {'nctId': 'NCT02971332', 'acronym': 'LTSTARR', 'briefTitle': 'Long Term Results of STARR With Contour Transtar', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'STARR With Contour Transtar for Obstructed Defecation Syndrome: Long Term Results', 'orgStudyIdInfo': {'id': 'STR016a'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Group', 'description': 'Patients candidated to STARR after the failure of medical and dietary therapy and after a complete radiological and functional study.', 'interventionNames': ['Procedure: Stapled Transanal Rectal Resection']}], 'interventions': [{'name': 'Stapled Transanal Rectal Resection', 'type': 'PROCEDURE', 'otherNames': ['STARR'], 'description': "The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex.\n\nThe longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure.", 'armGroupLabels': ['Treatment Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FACS', 'investigatorFullName': 'Francesco Saverio Mari, MD, PhD, FACS', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}