Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves - Full Text View

Purpose

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.

Condition	Intervention
Pelvic Organ Prolapse	Procedure: Device- Robotic sacral colpopexy


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by Shawn A Menefee, MD, Kaiser Permanente:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	100
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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).

Eligibility


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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535833

Contacts


Contact: Shawn A Menefee, MD	6192216398	shawn.a.menefee@kp.org
Contact: John N Nguyen, MD	5626572642	john.n.nguyen@kp.org

Locations


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

Sponsors and Collaborators

Kaiser Permanente

Investigators


Study Director:	Cynthia Brown	Southern California Kaiser permanente

More Information


Responsible Party:	Shawn A Menefee, MD, Principal Investigator, Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT01535833 History of Changes
Other Study ID Numbers:	KP IRB 20111224
Study First Received:	February 13, 2012
Last Updated:	May 10, 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

ClinicalTrials.gov processed this record on May 25, 2017