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.