Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-02 @ 10:04 PM
Study NCT ID:
NCT01535833
Status:
UNKNOWN
Last Update Posted:
2016-05-12
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-02-15', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Learning curve of robotic sacral colpopexy', 'timeFrame': '24 months', 'description': 'To assess learning curve during implementation of a new pelvic floor robotic program which will assess surgical time (total and specific essential portions), simulator training and surgeon, observational surgeon skills by surgeon, assistant and blinded assessor'}], 'secondaryOutcomes': [{'measure': 'Subjective outcomes for robotic sacral colpopexy', 'timeFrame': 'Two years', 'description': 'Subjective outcomes for robotic sacral colpopexy for prolapse and incontinence symptoms and sexual function using validated measures (PFDI-20), (PISQ-12)'}, {'measure': 'Adverse events for robotic sacral colpopexy', 'timeFrame': 'Two years', 'description': 'Adverse events for robotic sacral colpopexy including estimated blood loss, GU and GI injury, wound infection and mesh erosion'}, {'measure': 'Objective outcomes measures associated with robotic sacral colpopexy', 'timeFrame': '24 months', 'description': 'To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['robotic sacral colpopexy', 'Learning curve', 'Pelvic Organ Prolapse', 'Robotic Surgery'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.', 'detailedDescription': 'The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.\n\nThe investigators primary outcomes will be:\n\n* Surgical time: Key portion of procedure will be assessed along with total time for completion\n* Learning curve: Will be assessed using surgical times, VAS of camera skills, surgical skills involving tissue handling and movements and overall performance by surgeon, assistant and blind reviewer\n* Length of hospitalization: measured by days in hopsital\n\nThe investigators secondary outcomes will be:\n\n* Pre-operative and postoperative Pelvic Organ Prolapse-Quantification (POP-Q) at 6 week, 6, 12, and 24 months.\n* Pelvic Floor Distress Inventory-Short Form 20 Questionnaire (PFDI-20)\n* Mesh erosion,\n* Estimated blood loss,\n* Complications (bowel or bladder injury) and,\n* Wound infection,\n* Patient Global Impressions of Improvement\n* Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old\n* Females only\n* Undergoing robotic assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse\n* Willing to return for follow-up visits\n* Written informed consent obtained from each subject\n\nExclusion Criteria:\n\n* Decline to participate\n* Pregnant or contemplating future pregnancy (within a year)\n* Unable to participate in the informed consent process'}, 'identificationModule': {'nctId': 'NCT01535833', 'briefTitle': 'Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Subjective and Objective Outcomes With Learning Curves in the Development of a New Pelvic Floor Robotics Program', 'orgStudyIdInfo': {'id': 'KP IRB 20111224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Robotic sacral colpopexy', 'description': 'To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex', 'interventionNames': ['Procedure: Device- Robotic sacral colpopexy']}], 'interventions': [{'name': 'Device- Robotic sacral colpopexy', 'type': 'PROCEDURE', 'otherNames': ['Robotic Laparoscopic Sacral Colpopexy'], 'description': 'To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse', 'armGroupLabels': ['Robotic sacral colpopexy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90242', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John N Nguyen, MD', 'role': 'CONTACT', 'phone': '562-657-2642'}, {'name': 'John N Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Downey', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92110', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gisselle Zazueta', 'role': 'CONTACT', 'phone': '619-221-6274'}, {'name': 'Linda MacKinnon', 'role': 'CONTACT', 'phone': '6192216418'}, {'name': 'Shawn A Menefee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jasmine Tan-Kim, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Keisha Dyer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kaiser Permanente San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Shawn A Menefee, MD', 'role': 'CONTACT', 'email': 'shawn.a.menefee@kp.org', 'phone': '6192216398'}, {'name': 'John N Nguyen, MD', 'role': 'CONTACT', 'email': 'john.n.nguyen@kp.org', 'phone': '5626572642'}], 'overallOfficials': [{'name': 'Cynthia Brown', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Southern California Kaiser permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shawn A Menefee, MD', 'investigatorAffiliation': 'Kaiser Permanente'}}}}