Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
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ClinicalTrials.gov Identifier: NCT01535833 |
Recruitment Status
:
Recruiting
First Posted
: February 20, 2012
Last Update Posted
: May 12, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pelvic Organ Prolapse | Procedure: Device- Robotic sacral colpopexy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | July 2016 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Robotic sacral colpopexy
To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex
|
Procedure: Device- Robotic sacral colpopexy
To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse
Other Name: Robotic Laparoscopic Sacral Colpopexy
|
- Learning curve of robotic sacral colpopexy [ Time Frame: 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
- Subjective outcomes for robotic sacral colpopexy [ Time Frame: 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 [ Time Frame: Two years ]Adverse events for robotic sacral colpopexy including estimated blood loss, GU and GI injury, wound infection and mesh erosion
- Objective outcomes measures associated with robotic sacral colpopexy [ Time Frame: 24 months ]To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535833
Contact: Shawn A Menefee, MD | 6192216398 | shawn.a.menefee@kp.org | |
Contact: John N Nguyen, MD | 5626572642 | john.n.nguyen@kp.org |
United States, California | |
Kaiser Permanente Downey | Not yet recruiting |
Los Angeles, California, United States, 90242 | |
Contact: John N Nguyen, MD 562-657-2642 | |
Principal Investigator: John N Nguyen, MD | |
Kaiser Permanente San Diego | Recruiting |
San Diego, California, United States, 92110 | |
Contact: Gisselle Zazueta 619-221-6274 | |
Contact: Linda MacKinnon 6192216418 | |
Principal Investigator: Shawn A Menefee, MD | |
Sub-Investigator: Jasmine Tan-Kim, MD | |
Sub-Investigator: Keisha Dyer, MD |
Study Director: | Cynthia Brown | Southern California Kaiser permanente |
Responsible Party: | Shawn A Menefee, MD, Principal Investigator, Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT01535833 History of Changes |
Other Study ID Numbers: |
KP IRB 20111224 |
First Posted: | February 20, 2012 Key Record Dates |
Last Update Posted: | May 12, 2016 |
Last Verified: | May 2016 |
Keywords provided by Shawn A Menefee, MD, Kaiser Permanente:
robotic sacral colpopexy Learning curve Pelvic Organ Prolapse Robotic Surgery |
Additional relevant MeSH terms:
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |