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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01535833
• Other study ID #: KP IRB 20111224
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2012
• Last updated: October 22, 2014
• Start date: February 2012
• Est. completion date: February 2016

Study information

• Verified date: October 2014
• Source: Kaiser Permanente
• Contact: Shawn A Menefee, MD
• Phone: 6192216398
• Email: shawn.a.menefee[@]kp.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Device- Robotic sacral colpopexy
To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse

Locations

Country	Name	City	State
United States	Kaiser Permanente Downey	Los Angeles	California
United States	Kaiser Permanente San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	No