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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.
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.
The investigators primary outcomes will be:
The investigators secondary outcomes will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic sacral colpopexy | Other | To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device- Robotic sacral colpopexy | Procedure | To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Learning curve of robotic sacral colpopexy | 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective outcomes for robotic sacral colpopexy | Subjective outcomes for robotic sacral colpopexy for prolapse and incontinence symptoms and sexual function using validated measures (PFDI-20), (PISQ-12) | Two years |
| Adverse events for robotic sacral colpopexy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn A Menefee, MD | Contact | 6192216398 | shawn.a.menefee@kp.org | |
| John N Nguyen, MD | Contact | 5626572642 | john.n.nguyen@kp.org |
| Name | Affiliation | Role |
|---|---|---|
| Cynthia Brown | Southern California Kaiser permanente | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Downey | Not yet recruiting | Los Angeles | California | 90242 | United States |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Adverse events for robotic sacral colpopexy including estimated blood loss, GU and GI injury, wound infection and mesh erosion |
| Two years |
| Objective outcomes measures associated with robotic sacral colpopexy | To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months | 24 months |
| Kaiser Permanente San Diego | Recruiting | San Diego | California | 92110 | United States |
|