Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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).

Official Title
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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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Device- Robotic sacral colpopexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Robotic sacral colpopexy<br>To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex | Procedure: Device- Robotic sacral colpopexy<br>* To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse<br>* Other names: Robotic Laparoscopic Sacral Colpopexy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic sacral colpopexy, Learning curve, Pelvic Organ Prolapse, Robotic Surgery