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Robotic Surgery
Robotic-assisted Laparoscopic Sacrocolpopexy
N/A
Waitlist Available
Led By Felicia Lane, M.D.
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.
Eligible Conditions
- Pelvic Organ Prolapse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q).
Secondary study objectives
will measure the effects of the surgical repair using a series of questionnaires: SF-36, Pelvic Floor Distress Inventory which includes Pelvic Organ Prolapse Impact, Colo-Rectal-Anal Impact, and Urinary Impact Questionnaire.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Robotic Sacrocolpopexy GroupExperimental Treatment1 Intervention
laparoscopic mesh augmented prolapse repair for post-hysterectomy prolapse repair using the Da Vinci robot
Group II: Open Sacrocolpopexy GroupExperimental Treatment1 Intervention
matched cohort that underwent mesh augmented prolapse repair for post-hysterectomy prolapse performed via open laparotomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Robotic-assisted laparoscopic sacrocolpopexy
2007
N/A
~20
Open sacrocolpopexy
2007
N/A
~20
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,933,058 Total Patients Enrolled
4 Trials studying Pelvic Organ Prolapse
424 Patients Enrolled for Pelvic Organ Prolapse
Felicia Lane, M.D.Principal InvestigatorUniversity of California, Irvine