Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-26 @ 2:32 PM
Study NCT ID:
NCT01257659
Status:
TERMINATED
Last Update Posted:
2015-11-02
First Post:
2010-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D006547', 'term': 'Hernia'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Unable to find enough patients who accept randomization of surgical procedures.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2010-12-09', 'studyFirstSubmitQcDate': '2010-12-09', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence/absence of a 50% drop in the ODS score', 'timeFrame': '12 months', 'description': 'presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008.'}], 'secondaryOutcomes': [{'measure': 'presence/absence of prolapse recurrence', 'timeFrame': '6 weeks', 'description': 'presence/absence of prolapse recurrence: determined by prolapse staging'}, {'measure': 'Frequency of laxative use', 'timeFrame': '6 weeks'}, {'measure': 'Intervention time (min)', 'timeFrame': '1 day'}, {'measure': 'Questionnaire PFDI 20', 'timeFrame': '6 weeks'}, {'measure': 'Questionnaire PFIQ 7', 'timeFrame': '6 weeks'}, {'measure': 'Questionnaire SF 36', 'timeFrame': '6 weeks'}, {'measure': 'Questionnaire PISQ-12', 'timeFrame': '6 weeks'}, {'measure': 'presence/absence of prolapse recurrence', 'timeFrame': '6 months', 'description': 'presence/absence of prolapse recurrence: determined by prolapse staging'}, {'measure': 'presence/absence of prolapse recurrence', 'timeFrame': '12 months', 'description': 'presence/absence of prolapse recurrence: determined by prolapse staging'}, {'measure': 'presence/absence of prolapse recurrence', 'timeFrame': '36 months', 'description': 'presence/absence of prolapse recurrence: determined by prolapse staging'}, {'measure': 'Frequency of laxative use', 'timeFrame': '6 months'}, {'measure': 'Frequency of laxative use', 'timeFrame': '12 months'}, {'measure': 'Frequency of laxative use', 'timeFrame': '36 months'}, {'measure': 'Questionnaire PFDI 20', 'timeFrame': '6 months'}, {'measure': 'Questionnaire PFDI 20', 'timeFrame': '12 months'}, {'measure': 'Questionnaire PFDI 20', 'timeFrame': '36 months'}, {'measure': 'Questionnaire PFIQ 7', 'timeFrame': '6 months'}, {'measure': 'Questionnaire PFIQ 7', 'timeFrame': '12 months'}, {'measure': 'Questionnaire PFIQ 7', 'timeFrame': '36 months'}, {'measure': 'Questionnaire SF 36', 'timeFrame': '6 months'}, {'measure': 'Questionnaire SF 36', 'timeFrame': '12 months'}, {'measure': 'Questionnaire SF 36', 'timeFrame': '36 months'}, {'measure': 'Questionnaire PISQ-12', 'timeFrame': '6 months'}, {'measure': 'Questionnaire PISQ-12', 'timeFrame': '12 months'}, {'measure': 'Questionnaire PISQ-12', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rectocele', 'Trans anal STARR resection', 'Transvaginal repair'], 'conditions': ['Rectocele']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient is not under any type of guardianship\n* patient has a rectocele \\> 3 cm during defecography\n* patient has persistent defecatory troubles depite medical treatment (laxatives for at least 1 month) and an ODS score \\> 10\n* patient recieved information and signed the consent form\n\nExclusion Criteria:\n\n* patient cannot read French\n* patient has an asymptomatic rectocele\n* patient with an enterocele at rest upon defecography, with opacification of the small bowel\n* patient with non-rehabilitated anorectal asynchrony (anism)\n* patient with anal incontinence, Wexner score \\> 7\n* patient has a rectal lesion\n* patient has previously had rectal surgery including a colorectal anastomosis\n* patient has previously had a surgery involving disection of the rectovaginal wall, except for myorraphy of relever muscles\n* patient has previously had pelvic radiotherapy\n* anal sphincter insufficiency detected by rectomanometry\n* megarectum detected by rectomanometry and defecography\n* granule transit anomaly: \\> 70h\n* exteriorized rectal prolapse\n* rectovaginal fistule\n* intestinal inflammatory disease\n* anal stenosis\n* anal or rectal tumor\n* patient refuses to participate or refuses to sign consent\n* patient is enrolled in another study\n* contra indication for general or localized anesthesia\n* patient does not have social security coverage'}, 'identificationModule': {'nctId': 'NCT01257659', 'acronym': 'RectoVerso', 'briefTitle': 'STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function', 'orgStudyIdInfo': {'id': 'PHRC-I/2010/RdeT-01'}, 'secondaryIdInfos': [{'id': '2010-A00665-34', 'type': 'OTHER', 'domain': 'Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STARR arm', 'description': 'In this group of patients, the STARR transanal stapling system is used to treat the rectocele.', 'interventionNames': ['Procedure: STARR rectocele repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Elevate arm', 'description': 'In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele.', 'interventionNames': ['Procedure: Elevate mesh rectocele repair']}], 'interventions': [{'name': 'STARR rectocele repair', 'type': 'PROCEDURE', 'description': 'The STARR transanal stapling system is used to repair a rectocele.', 'armGroupLabels': ['STARR arm']}, {'name': 'Elevate mesh rectocele repair', 'type': 'PROCEDURE', 'description': 'A posterior Elevate mesh is placed transvaginally to repair a rectocele.', 'armGroupLabels': ['Elevate arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Beau Soleil', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Clinique Adassa', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Paule de Viguier, CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Purpan, CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Renaud de Tayrac, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}