The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.
Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes. Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Posterior repair with graft
Native tissue repair
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Anatomic cure defined by standardized POPQ measures
Time frame: 12 months
Quality of life based on PFIQ validated questionnaire
Time frame: 12 months
Sexual function
Time frame: 12 months
Patient centered goals
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.