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

Kaiser Permanente

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Device- Robotic sacral colpopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01535833

KP IRB 20111224

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Robotic sacral colpopexy

Other group

Description:

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

Treatment:

Procedure: Device- Robotic sacral colpopexy