Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?
Completed
Conditions studied: Pelvic Organ Prolapse
In brief
The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair. We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.
Key facts
- Study ID
- NCT02049996
- Run by
- TriHealth Inc.
- People needed
- 78
- Starts
- 2014-01-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-09-09
Who can join
Age: 18 and older, up to 90. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- patients of Cincinnati Urogynecology Associates
- aged 18-90
- planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal.
- undergoing general anesthesia
- able to speak and read English
- able to understand the informed consent statement
You may not qualify if…
- scheduled for repairs not involving a hysterectomy
- use of mesh in the vaginal prolapse repair
- obliterative procedures to the vagina
- concurrent removal of a suburethral sling
- anterior, posterior or apical vaginal mesh kit at the time of their surgery
- performance of vaginal 'relaxing incisions' at the time of vaginal surgery
- concurrent anal incontinence repair such as a sphincteroplasty
- presence of uterine, cervical or ovarian malignancy
- use of regional anesthesia for their surgery.
Where it is running
- TriHealth Good Samaritan Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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