Rectocele
Conditions
Brief summary
Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.
Interventions
PROCEDUREInsertion of pelvicol graft
Pelvicol graft
Sponsors
Urogynecology Associates, Indiana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy
Exclusion criteria
* concomitant colo-rectal procedure * allergy to pork * any contraindication to laparoscopic sacrocolpopexy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomic success of rectocele repair | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| change in patient symptomatology post-operatively | 6 months |
Countries
United States
Contacts
Primary ContactDouglass S Hale, MD
Outcome results
None listed