Pelvic Organ Prolapse
Conditions
Keywords
robotic sacral colpopexy, Learning curve, Pelvic Organ Prolapse, Robotic Surgery
Brief summary
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.
Detailed description
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: * Surgical time: Key portion of procedure will be assessed along with total time for completion * 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 * Length of hospitalization: measured by days in hopsital The investigators secondary outcomes will be: * Pre-operative and postoperative Pelvic Organ Prolapse-Quantification (POP-Q) at 6 week, 6, 12, and 24 months. * Pelvic Floor Distress Inventory-Short Form 20 Questionnaire (PFDI-20) * Mesh erosion, * Estimated blood loss, * Complications (bowel or bladder injury) and, * Wound infection, * Patient Global Impressions of Improvement * Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
Interventions
PROCEDUREDevice- Robotic sacral colpopexy
To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse
Sponsors
Kaiser Permanente
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years old * Females only * Undergoing robotic assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse * Willing to return for follow-up visits * Written informed consent obtained from each subject
Exclusion criteria
* Decline to participate * Pregnant or contemplating future pregnancy (within a year) * Unable to participate in the informed consent process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Learning curve of robotic sacral colpopexy | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective outcomes for robotic sacral colpopexy | Two years | Subjective outcomes for robotic sacral colpopexy for prolapse and incontinence symptoms and sexual function using validated measures (PFDI-20), (PISQ-12) |
| Adverse events for robotic sacral colpopexy | Two years | Adverse events for robotic sacral colpopexy including estimated blood loss, GU and GI injury, wound infection and mesh erosion |
| Objective outcomes measures associated with robotic sacral colpopexy | 24 months | To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months |
Countries
United States
Contacts
Primary ContactShawn A Menefee, MD
Backup ContactJohn N Nguyen, MD
Outcome results
None listed