Clinical trial NCT01535833: Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: robotic sacral colpopexy
Learning curve
Pelvic Organ Prolapse
Robotic Surgery
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Learning curve of robotic sacral colpopexy
timeFrame: 24 months
Secondary outcomes:
measure: Subjective outcomes for robotic sacral colpopexy
timeFrame: Two years
measure: Adverse events for robotic sacral colpopexy
timeFrame: Two years
measure: Objective outcomes measures associated with robotic sacral colpopexy
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Downey
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego
state: California
Study officials:
affiliation: Southern California Kaiser permanente
name: Cynthia Brown
role: STUDY_DIRECTOR
References: