NCT01535833

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Device- Robotic sacral colpopexy	To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2012-02-20
• Last updated: 2016-05-12

Locations

2 sites across 1 country: United States