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



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:February 2012
End Date:February 2016
Contact:Shawn A Menefee, MD
Email:shawn.a.menefee@kp.org
Phone:6192216398

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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

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 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).

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
We found this trial at
2
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San Diego, California 92120
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Los Angeles, California 90242
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Los Angeles, CA
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