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

• ClinicalTrials.gov Identifier: NCT01535833
• Recruitment Status: Unknown
• First Posted: February 20, 2012
• Last Update Posted: May 12, 2016
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): Shawn A Menefee, MD, Kaiser Permanente

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.

Condition or disease	Intervention/treatment	Phase
Pelvic Organ Prolapse	Procedure: Device- Robotic sacral colpopexy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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)
2. 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
3. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: KP IRB 20111224
• First Posted: February 20, 2012
• 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