Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial

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.

Inclusion Criteria:

• Women with stage 2 or greater symptomatic rectocele
• Women electing to undergo surgical rectocele repair
• Women over age 21 years
• Women willing to comply with study procedures and follow-up

Exclusion Criteria:

• Pregnant or nursing women
• History of porcine allergy
• History of connective tissue disease, pelvic malignancy, or pelvic radiation
• Women undergoing concurrent sacral colpopexy