Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-29 @ 1:50 PM
Study NCT ID:
NCT03715803
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asampietro@live.com.ar', 'phone': '+5491158336327', 'title': 'Dr. Agustín Sampietro', 'organization': 'Universidad de Buenos Aires'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Retrospective study; CaA procedures started a long time before the first CaS cases (Ca S level of surgeon training more experienced). Available data only enables mid-term follow-ups of differing duration's between the two groups."}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S', 'eventGroups': [{'id': 'EG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 30, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 14, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reoperation for prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mesh erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Cured Participants According to Barber Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'OG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}], 'classes': [{'categories': [{'measurements': [{'value': '82.42', 'groupId': 'OG000'}, {'value': '90.48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-operative at 6 months', 'description': 'According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.', 'unitOfMeasure': 'percentage of cured patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'OG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}], 'classes': [{'categories': [{'measurements': [{'value': '82.42', 'groupId': 'OG000'}, {'value': '88.88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-operative and post-operative at 6 months', 'description': 'Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1.', 'unitOfMeasure': 'percentage of cured patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Status: Patient Global Impression Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'OG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative at 6 months', 'description': 'Patient satisfaction with the experience and the result of procedure will be evaluated with the "Patient Global Impression" questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'OG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}], 'timeFrame': 'Intra-operative and post-operative at 6 months', 'description': 'Register of adverse events. Clavien-Dindo classification', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse events were presented in a separate section.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life: PFDI 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'OG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}], 'classes': [{'categories': [{'measurements': [{'value': '30.85', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '91.1'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '52.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative at 6 months', 'description': 'Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life: PISQ-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'OG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative at 6 months', 'description': 'Quality of life assessed with "Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12)" to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'FG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP\n\nCalistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses'}, {'id': 'BG001', 'title': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP\n\nCalistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'spread': '9', 'groupId': 'BG000'}, {'value': '62', 'spread': '8', 'groupId': 'BG001'}, {'value': '62', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-28', 'size': 285554, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-06T15:03', 'hasProtocol': True}, {'date': '2018-05-28', 'size': 189617, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-06T15:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2018-09-26', 'resultsFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2018-10-19', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-06', 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life: PFDI 20', 'timeFrame': 'Post-operative at 6 months', 'description': 'Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress).'}, {'measure': 'Quality of Life: PISQ-12', 'timeFrame': 'Post-operative at 6 months', 'description': 'Quality of life assessed with "Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12)" to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48.'}], 'primaryOutcomes': [{'measure': 'Percentage of Cured Participants According to Barber Criteria', 'timeFrame': 'Post-operative at 6 months', 'description': 'According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)', 'timeFrame': 'Pre-operative and post-operative at 6 months', 'description': 'Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1.'}, {'measure': 'Quality of Life Status: Patient Global Impression Questionnaire', 'timeFrame': 'Post-operative at 6 months', 'description': 'Patient satisfaction with the experience and the result of procedure will be evaluated with the "Patient Global Impression" questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome.'}, {'measure': 'Adverse Events', 'timeFrame': 'Intra-operative and post-operative at 6 months', 'description': 'Register of adverse events. Clavien-Dindo classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '15589779', 'type': 'BACKGROUND', 'citation': 'de Tayrac R, Madelenat P. [Evolution of surgical routes in female stress urinary incontinence]. Gynecol Obstet Fertil. 2004 Dec;32(12):1031-8. doi: 10.1016/j.gyobfe.2004.10.019. French.'}, {'pmid': '26436858', 'type': 'BACKGROUND', 'citation': 'Bigozzi MA, Provenzano S, Maeda F, Palma P, Riccetto C. In vivo biomechanical properties of heavy versus light weight monofilament polypropylene meshes. Does the knitting pattern matter? Neurourol Urodyn. 2017 Jan;36(1):73-79. doi: 10.1002/nau.22890. Epub 2015 Oct 5.'}, {'pmid': '19701041', 'type': 'BACKGROUND', 'citation': 'Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-609. doi: 10.1097/AOG.0b013e3181b2b1ae.'}, {'pmid': '22517068', 'type': 'BACKGROUND', 'citation': 'Toozs-Hobson P, Freeman R, Barber M, Maher C, Haylen B, Athanasiou S, Swift S, Whitmore K, Ghoniem G, de Ridder D; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Neurourol Urodyn. 2012 Apr;31(4):415-21. doi: 10.1002/nau.22238.'}, {'pmid': '19638912', 'type': 'BACKGROUND', 'citation': 'Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft).', 'detailedDescription': 'The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft). In such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. Safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* Anterior and apical prolapse Stage 3 (according to POP-Q) or more with or without stress urinary incontinence (SUI)\n* Primary or recurrent treatment with Calistar S or Calistar A\n* At least 6 months follow-up\n\nExclusion Criteria:\n\n* Recurrent vaginal infections,\n* Chronic colorectal diseases (chronic nonspecific ulcerative colitis, diverticulitis, diverticulosis, Chron's disease, irritable bowel syndrome, familial polyposis).\n* Presence of any coagulopathies,\n* Impairment of the immune system or any condition that compromises recovery,\n* Prior irradiation\n* Chronic pelvic pain"}, 'identificationModule': {'nctId': 'NCT03715803', 'briefTitle': 'Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems', 'organization': {'class': 'OTHER', 'fullName': 'University of Buenos Aires'}, 'officialTitle': 'Calistar A vs. Calistar S - Cohort Retrospective Analysis', 'orgStudyIdInfo': {'id': 'CaSCaA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Calistar A', 'description': 'Calistar A mesh to treat anterior and apical POP', 'interventionNames': ['Device: Calistar A mesh to treat anterior and apical POP']}, {'label': 'Calistar S', 'description': 'Calistar S mesh to treat anterior and apical POP', 'interventionNames': ['Device: Calistar S mesh to treat anterior and apical POP']}], 'interventions': [{'name': 'Calistar A mesh to treat anterior and apical POP', 'type': 'DEVICE', 'description': 'Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses', 'armGroupLabels': ['Calistar A']}, {'name': 'Calistar S mesh to treat anterior and apical POP', 'type': 'DEVICE', 'description': 'Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses', 'armGroupLabels': ['Calistar S']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1280AEB', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Británico', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Agustín Sampietro, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, University of Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only final clinical study report will be shared with the researchers participating in the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agustin Sampietro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gynecologist', 'investigatorFullName': 'Agustin Sampietro', 'investigatorAffiliation': 'University of Buenos Aires'}}}}