A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery

<p>Abstract</p> <p>Background</p> <p>A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform^®Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery.</p> <p>Methods</p> <p>Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study.</p> <p>Results</p> <p>The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform^®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event.</p> <p>Conclusion</p> <p>This study is the first to investigate the use of Xenform^®Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT01244165</p

Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy

The purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy. This is a retrospective cohort study of women who underwent MISC between November 2004 and January 2009. Demographics, operative techniques, and outcomes were abstracted from medical records. Multivariable regression identified odds of erosion. Of 188 MISC procedures 19(10%) had erosions. Erosion was higher in those with total vaginal hysterectomy (TVH) compared to both post-hysterectomy (23% vs. 5%, p = 0.003) and supracervical hysterectomy (SCH) (23% vs. 5%, p = 0.109) groups. In multivariable regression, the odds of erosion for TVH was 5.67 (95% CI: 1.88–17.10) compared to post-hysterectomy. Smoking, the use of collagen-coated mesh, transvaginal dissection, and mesh attachment transvaginally were no longer significant in the multivariable regression model. Based on this study, surgeons should consider supracervical hysterectomy over total vaginal hysterectomy as the procedure of choice in association with MISC unless removal of the cervix is otherwise indicated

Midline fascial plication under continuous digital transrectal control: which factors determine anatomic outcome?

Contains fulltext : 88897.pdf (publisher's version ) (Closed access)INTRODUCTION AND HYPOTHESIS: The aim of the study was to report anatomic and functional outcome of midline fascial plication under continuous digital transrectal control and to identify predictors of anatomic failure. METHODS: Prospective observational cohort. Anatomic success defined as POP-Q stage or= II underwent midline fascial plication under continuous digital transrectal control. Median follow-up was 14 months (12-35 months), and anatomic success was 80.3% (95% CI 75-86). Independent predictors of failure were posterior compartment POP stage >or= III [OR 8.7 (95% CI 2.7-28.1)] and prior colposuspension [OR 5.6 (95% CI 1.1-27.8)]. Sixty-three percent of patients bothered by obstructed defaecation experienced relief after surgery. CONCLUSIONS: Anatomic and functional outcomes were good. Risk factors for anatomic failure were initial size of posterior POP (stage >or= III) and prior colposuspension.1 juni 201

Robot-assisted surgery for the management of apical prolapse: a bicentre prospective cohort study

Objective: Robot‐assisted surgery is a recognized treatment for pelvic‐organ prolapse. Many of the surgical subgroup outcomes for apical prolapse are reported together leading to a paucity of homogenous data. Design: Prospective observational cohort study (https://clinicaltrials.gov; identifier NCT01598467) assessing outcomes for homogeneous subgroups of robot‐assisted apical prolapse surgery. Setting: Two European tertiary referral hospitals. Population: Consecutive patients undergoing robot‐assisted sacrocolpopexy (RASC) and supracervical hysterectomy with sacrocervicopexy (RSHS). Methods: Anatomical cure (simplified Pelvic Organ Prolapse Quantification (sPOPQ) stage 1,), subjective cure (symptoms of bulge) and quality of life (Pelvic Floor Impact Questionnaire [PFIQ‐7]). Main Outcome measures: Primary outcome: anatomical and subjective cure. Secondary outcomes: surgical safety and intraoperative variables. Results: Total 305 patients included (RASC N=188, RSHS N=117). Twelve months follow‐up available for 144 (RASC 76.6%) and 109 (RSHS 93.2%). Anatomical success of the apical compartment occurred in 91% (RASC) and in 99% (RSHS). In all compartments, success percentages were 67% and 65% respectively. Most recurrences were anterior compartment (15.7% RASC [symptomatic 12.1%]; 22.9% RSHS [symptomatic 4.8%]). Symptoms of bulge improved from 97.4% to 17.4% (p<0.0005). PFIQ‐7 scores improved from 76.7 ± 62.3 to 13.5 ± 31.1 (p<0.0005). Duration of surgery increased significantly in RSHS (183.1 ± 38.2 versus 145.3 ± 29.8 [p<0.0005]). Intraoperative complications and conversion rates were low (RASC: 5.3% and 4.3%; RSHS: 0.0% and 0.0%). Four severe postoperative complications occurred after RASC (2.1%) and one after RSHS (1.6%). Conclusion: This is the largest reported prospective cohort study on robot‐assisted apical prolapse surgery. Both procedures are safe, with durable results