Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Kaiser Permanente
Sponsor:
Information provided by (Responsible Party):
Shawn A Menefee, MD, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01535833
First received: February 13, 2012
Last updated: May 10, 2016
Last verified: May 2016
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Learning curve of robotic sacral colpopexy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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)
Genders 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
Health Authority: United States: Institutional Review Board

Keywords provided by 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 September 30, 2016