Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Procedure: Device- Robotic sacral colpopexy
- Registration Number
- NCT01535833
- Lead Sponsor
- Kaiser Permanente
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- > 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
- Decline to participate
- Pregnant or contemplating future pregnancy (within a year)
- Unable to participate in the informed consent process
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Robotic sacral colpopexy Device- Robotic sacral colpopexy To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (2)
Kaiser Permanente Downey
🇺🇸Los Angeles, California, United States
Kaiser Permanente San Diego
🇺🇸San Diego, California, United States