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

NCT ID: NCT01535833

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-12-31

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).

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic sacral colpopexy

To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex

Group Type: OTHER

Device- Robotic sacral colpopexy

Intervention Type: PROCEDURE

To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse

Interventions

Device- Robotic sacral colpopexy

To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse

Intervention Type: PROCEDURE

Other Intervention Names

Robotic Laparoscopic Sacral Colpopexy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Shawn A Menefee, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Brown

Role: STUDY_DIRECTOR

Southern California Kaiser permanente

Locations

Kaiser Permanente Downey

Los Angeles, California, United States

Site Status: NOT_YET_RECRUITING

Kaiser Permanente San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shawn A Menefee, MD

Role: CONTACT

shawn.a.menefee@kp.org

6192216398

John N Nguyen, MD

Role: CONTACT

john.n.nguyen@kp.org

5626572642

Facility Contacts

John N Nguyen, MD

Role: primary

562-657-2642

Gisselle Zazueta

Role: primary

619-221-6274

Linda MacKinnon

Role: backup

6192216418

Other Identifiers

KP IRB 20111224

Identifier Type: -

Identifier Source: org_study_id