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

Pelvic Organ Prolapse Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

• NCT number: NCT01535833
• Study type: Interventional
• Source: Kaiser Permanente
• Contact: Shawn A Menefee, MD
• Phone: 6192216398
• Email: shawn.a.menefee@kp.org
• Status: Recruiting
• Phase: N/A
• Start date: February 2012
• Completion date: February 2016