Study design
This study was reviewed and approved by the Hartford Hospital Institutional Review Board. Our cohort study included all women who underwent abdominal sacrocolpopexy using autologous rectus fascia between January 2010 and December 2019 at a single academic medical center. While we most commonly performed minimally invasive sacrocolpopexy using synthetic mesh, patients were offered a non-mesh alternative using autologous tissue. Patients were thoroughly counseling regarding limited available data on the outcomes of this procedure. Patients were eligible for the study if they were female, ≥18 years old and underwent abdominal sacrocolpopexy using autologous rectus fascia. Patients were excluded if they had a history of a prior sacrocolpopexy or if synthetic mesh was used for the procedure. Eligible patients were identified by review of operative log books and billing records, and surgical procedures were confirmed by review of the full operative notes. As part of standard practice, all patients were asked preoperatively to complete a validated prolapse symptom questionnaire (Pelvic Floor Dysfunction Inventory, PFDI-20) and this data was also collected. Pre- and post-operative pelvic organ quantification (POP-Q) measurements were recorded.
Patients were recruited for a follow-up visit including completing the PFDI-20 and POP-Q exam. Over the course of 2015 to 2020, eligible patients were called and offered to return to the office for an examination and complete the follow-up PFDI questionnaire and if unable or unwilling to come for a visit, were asked to complete the questionnaire by phone. Examinations were performed by an author not involved in the initial surgery. For patients who did not return to the office for a study visit, their most recent POP-Q examination from routine postop follow-up was used. Follow-up time was defined as the time between surgery and the date of the last post-operative POP-Q examination or PFDI-20 questionnaire.
Our primary outcomes were subjective symptoms as measured by PFDI-20 and anatomic prolapse staging as measured by POP-Q examinations. We reported a composite measure of treatment failure that included retreatment for prolapse (pessary or surgery), anatomic outcomes as defined by any POP-Q measure beyond the hymen, and symptomatic outcome defined as a positive response (with any degree of bother other than ”not at all”) to the PFDI question ”Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?”. Secondary outcomes included post-operative complications including readmission, transfusion, reoperation and infections. Demographic and medical data included age, race, ethnicity, body mass index, previous hysterectomy, prior incontinence surgery, prior prolapse surgery, smoking status, parity, history of diabetes mellitus, hypertension, hyperlipidemia, and asthma. Surgical data included concomitant surgeries, operative time, postoperative hematocrit level, length of stay, and postoperative complications within 30 days.