Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
Primary Purpose
Pelvic Organ Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device- Robotic sacral colpopexy
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring robotic sacral colpopexy, Learning curve, Pelvic Organ Prolapse, Robotic Surgery
Eligibility 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
Sites / Locations
- Kaiser Permanente Downey
- Kaiser Permanente San DiegoRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Robotic sacral colpopexy
Arm Description
To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex
Outcomes
Primary Outcome Measures
Learning curve of robotic sacral colpopexy
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
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
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
To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01535833
Brief Title
Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
robotic sacral colpopexy, Learning curve, Pelvic Organ Prolapse, Robotic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robotic sacral colpopexy
Arm Type
Other
Arm Description
To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex
Intervention Type
Procedure
Intervention Name(s)
Device- Robotic sacral colpopexy
Other Intervention Name(s)
Robotic Laparoscopic Sacral Colpopexy
Intervention Description
To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse
Primary Outcome Measure Information:
Title
Learning curve of robotic sacral colpopexy
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Subjective outcomes for robotic sacral colpopexy
Description
Subjective outcomes for robotic sacral colpopexy for prolapse and incontinence symptoms and sexual function using validated measures (PFDI-20), (PISQ-12)
Time Frame
Two years
Title
Adverse events for robotic sacral colpopexy
Description
Adverse events for robotic sacral colpopexy including estimated blood loss, GU and GI injury, wound infection and mesh erosion
Time Frame
Two years
Title
Objective outcomes measures associated with robotic sacral colpopexy
Description
To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn A Menefee, MD
Phone
6192216398
Email
shawn.a.menefee@kp.org
First Name & Middle Initial & Last Name or Official Title & Degree
John N Nguyen, MD
Phone
5626572642
Email
john.n.nguyen@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Brown
Organizational Affiliation
Southern California Kaiser permanente
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente Downey
City
Los Angeles
State/Province
California
ZIP/Postal Code
90242
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John N Nguyen, MD
Phone
562-657-2642
First Name & Middle Initial & Last Name & Degree
John N Nguyen, MD
Facility Name
Kaiser Permanente San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gisselle Zazueta
Phone
619-221-6274
First Name & Middle Initial & Last Name & Degree
Linda MacKinnon
Phone
6192216418
First Name & Middle Initial & Last Name & Degree
Shawn A Menefee, MD
First Name & Middle Initial & Last Name & Degree
Jasmine Tan-Kim, MD
First Name & Middle Initial & Last Name & Degree
Keisha Dyer, MD
12. IPD Sharing Statement
Learn more about this trial
Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
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