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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Device- Robotic 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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90242
      • Not yet recruiting
      • Kaiser Permanente Downey
      • Contact: John N Nguyen, MD; Phone Number: 562-657-2642
      • Principal Investigator: John N Nguyen, MD
    • San Diego, California, United States, 92110
      • Recruiting
      • Kaiser Permanente San Diego
      • Contact: Gisselle Zazueta; Phone Number: 619-221-6274
      • Contact: Linda MacKinnon; Phone Number: 6192216418
      • Principal Investigator: Shawn A Menefee, MD
      • Sub-Investigator: Jasmine Tan-Kim, MD
      • Sub-Investigator: Keisha Dyer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Robotic Laparoscopic Sacral Colpopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Two years
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	Two years
Objective outcomes measures associated with robotic sacral colpopexy	To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months	24 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Study Director: Cynthia Brown, Southern California Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 20, 2012

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; Robotic Surgery; Learning curve; robotic sacral colpopexy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: KP IRB 20111224