Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-31 @ 5:07 PM
Study NCT ID:
NCT06934304
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Redesigned Handout for Robotic Sacrocolpopexy on Patient Preoperative Preparedness and Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient preparedness', 'timeFrame': 'Assessed at the postoperative visit 4 to 6 weeks after srugery', 'description': 'Patients sense of preparedness for robotic sacrocolpopexy was measured with a series of 5 point Likert style questions (ranging strongly disagree to strongly agree). Specifically, patients were asked how satisfied the were with 1) information provided by their surgeon, 2) time spent with the patient preparing them for surgery, 3) overall sense of sense of preparedness.'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '4 week postoperatively', 'description': 'patient satisfaction for their overall experience undergoing robotic was assessed using a 5 point patient score. Scores ranged from extremely dissatisfied to extremely satisfied'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic sacrocolpopexy handout study'], 'conditions': ['Pelvic Organ Prolapse', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a new preoperative handout for patients undergoing robotic sacrocolpopexy will improve patient sense of preparedness and satisfaction in comparison to the previously used handout. The main questions it aims to answer are:\n\n* Does the new preoperative handout for patients undergoing robotic sacrocolpopexy improve patient preparedness and satisfaction?\n* Will the new preoperative handout for patients undergoing robotic sacrocolpopexy impact postoperative queries in the form of phone calls and messages to the clinic?\n\nParticipants will:\n\n* Receive routine counseling regarding robotic sacrocolpopexy from their surgeon\n* Be randomized to the new or old preoperative handout\n* Undergo robotic sacrocolpopexy\n* Complete a questionnaire at their 4 week postoperative follow up visit regarding their sense of preparedness for surgery and overall satisfaction'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures.\n\nExclusion Criteria:\n\n* patients unable to provide informed consent, those undergoing other concomitant major abdominal surgeries, patients less than 18 years old, pregnant patients, non-English speaking patients, and patients planning postoperative follow up at an outside facility.'}, 'identificationModule': {'nctId': 'NCT06934304', 'briefTitle': 'The Impact of a Redesigned Handout for Robotic Sacrocolpopexy on Patient Preoperative Preparedness and Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Randomized Controlled Study on Patient Preoperative Preparedness and Satisfaction Using a Redesigned Handout for Robotic Sacrocolpopexy', 'orgStudyIdInfo': {'id': 'STU-2022-0305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Old preoperative handout', 'description': 'Standard or old preoperative handout for robotic sacrocolpopexy was based off of the handout for robotic sacrocolpopexy from the American Urogynecologic Society', 'interventionNames': ['Other: old preoperative handout']}, {'type': 'EXPERIMENTAL', 'label': 'New preoperative handout', 'description': 'A new preoperative handout for robotic sacrocolpopexy was designed by changing the old preoperative handout such that it was written at a lower grade reading level and provided more perioperative details', 'interventionNames': ['Other: new preoperative handout']}], 'interventions': [{'name': 'new preoperative handout', 'type': 'OTHER', 'description': 'A new preoperative handout for robotic sacrocolpopexy was designed at a lower reading level and providing more perioperative details', 'armGroupLabels': ['New preoperative handout']}, {'name': 'old preoperative handout', 'type': 'OTHER', 'description': 'The old or standard preoperative handout for robotic sacrocolpopexy', 'armGroupLabels': ['Old preoperative handout']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas, Southwestern Medical Center at Dallas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology Fellow', 'investigatorFullName': 'Christine Herforth', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}