Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-02 @ 10:04 PM
Study NCT ID:
NCT01535833
Status:
UNKNOWN
Last Update Posted:
2016-05-12
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
Sponsor:
Kaiser Permanente
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: