Robot-assisted sacrocolpopexy: not only for vaginal vault suspension? An observational cohort study.

INTRODUCTION AND HYPOTHESIS: Surgery for pelvic organ prolapse (POP) has high recurrence rates. Long-term anatomical and patient-reported outcomes after pelvic floor repair are therefore required. METHODS: This prospective observational cohort study was conducted in a teaching hospital with tertiary referral function for patients with POP. Patients with symptomatic vaginal vault or uterine prolapse (simplified POP Quantification [sPOPQ] stage ≥2), who underwent robot-assisted sacrocolpopexy (RASC) or supracervical hysterectomy with sacrocervicopexy (RSHS), were included. Follow-up visits with sPOPQ evaluations were planned 4 years after surgery. Patients received pre- and postoperative questionnaires reporting symptoms of vaginal bulge, Urogenital Distress Inventory (UDI-6), and Pelvic Floor Impact Questionnaire (PFIQ-7). Primary outcome was patient self-reported symptoms. Secondary outcome was anatomical cure (sPOPQ stage 1) for all vaginal compartments. RESULTS: Seventy-seven patients were included. Sixty-one patients (79%) were evaluated after 50 months (physical examination n = 51). Symptoms of bulge (95% vs 15% p ˂ 0.0005), median UDI-6 scores (26.7 vs 22.2, p = 0.048), median PFIQ-7 scores (60.0 vs 0, p = 0.008), and median sPOPQ stages in all landmarks improved significantly from the pre- to the postoperative visit. Thirty patients (59%) were completely recurrence free and 96% of patients had no apical recurrence. Most recurrences were asymptomatic cystoceles (20%). There was one surgical re-intervention for recurrent prolapse (1.6%). CONCLUSIONS: Robot-assisted sacrocolpopexy and RSHS show sustainable results in the treatment of prolapse. Symptoms of bulge, urinary symptoms, and quality of life improved substantially 50 months postoperatively. Patients should be counseled about the risk of anterior wall recurrence and the small chance of recurrent symptoms that need treatment.

Long-term Anatomical and Functional Results of Robot-Assisted Pelvic Floor Surgery for the Management of Multicompartment Prolapse: A Prospective Study.

BACKGROUND: Long-term data on robot-assisted sacrocolporectopexy for the treatment of multicompartment pelvic organ prolapse are scarce. With the rising prevalence of prolapse and increasing surgical repair, it is essential to evaluate long-term results. OBJECTIVE: This study aimed to evaluate long-term functional and anatomic outcomes after sacrocolporectopexy. DESIGN: This is a prospective, observational cohort study. SETTINGS: This study was conducted at a teaching hospital with tertiary referral function for patients with gynecological/rectal prolapse. PATIENTS: All patients undergoing robot-assisted sacrocolporectopexy from 2011 to 2012 were included. INTERVENTION: Robot-assisted sacrocolporectopexy was performed. MAIN OUTCOME MEASURES: The primary outcome was the anatomic cure rate after 1 and 4 years, defined as simplified pelvic organ prolapse quantification stage 1 vaginal apical prolapse and no external rectal prolapse or internal rectal prolapse present. Kaplan-Meier curves were used for determination of recurrence-free intervals. Secondary outcomes were functional pelvic floor symptoms (symptoms of bulge, obstructed defecation, fecal incontinence, urogenital distress inventory) and quality of life (Pelvic Floor Impact Questionnaire). RESULTS: Fifty-three patients were included. After 12 and 48 months, the recurrence-free intervals based on Kaplan-Meier estimates were 100% and 90%. In total, there were 10 recurrences: 2 apical and 8 internal rectal prolapses. Symptoms of bulge (94%-12%; p < 0.0005), fecal incontinence (62%-32%; p < 0.0005), obstructed defecation (59%-24%; p = 0.008), and median Pelvic Floor Impact Questionnaire scores (124-5; p = 0.022) improved significantly at final follow-up. Median urogenital distress inventory scores showed improvement after 1 year (30-13; p = 0.021). LIMITATIONS: This was an observational, single-center study with selective postoperative imaging. CONCLUSIONS: Ninety percent of patients were recurrence free 48 months after robot-assisted sacrocolporectopexy. Symptoms of vaginal bulge, quality of life, constipation, and fecal incontinence improved significantly. However, a subgroup of patients showed persistent bowel complaints that underlie the complexity of multicompartment prolapse. See Video Abstract at http://links.lww.com/DCR/B265. RESULTADOS ANATÓMICOS Y FUNCIONALES A LARGO PLAZO DE LA CIRUGÍA DE PISO PÉLVICO ASISTIDA POR ROBOT EN EL TRATAMIENTO DEL PROLAPSO MULTICOMPARTIMENTAL: UN ESTUDIO PROSPECTIVO: Los datos a largo plazo sobre la sacrocolporectopexia asistida por robot para el tratamiento del prolapso multicompartimental de órganos pélvicos son escasos. Con el aumento de la prevalencia del prolapso y el aumento de la reparación quirúrgica, es esencial evaluar los resultados a largo plazo.Evaluar los resultados funcionales y anatómicos a largo plazo después de la sacrocolporectopexia.Estudio prospectivo observacional de cohorte.Hospital de enseñanza con función de referencia terciaria para pacientes con prolapso ginecológico/rectal.Todos los pacientes sometidos a sacrocolporectopexia asistida por robot en 2011-2012.Sacrocolporectopexia asistida por robot.El resultado primario fue la tasa de curación anatómica a uno y cuatro años, definida como etapa 1 de prolapso apical vaginal en la cuantificación del prolapso de órganos pélvicos simplificado, y sin prolapso rectal externo o prolapso rectal interno presentes. Se utilizaron curvas de Kaplan Meier para determinar los intervalos libres de recurrencia. Los resultados secundarios fueron síntomas funcionales del piso pélvico (síntomas de abultamiento, obstrucción defecatoria, incontinencia fecal, inventario de molestias urogenitales) y calidad de vida (cuestionario de impacto del piso pélvico).Se incluyeron 53 pacientes. Después de 12 y 48 meses, el intervalo libre de recurrencia basado en las estimaciones con método Kaplan Meier fue del 100% y 90%, respectivamente. En total hubo diez recurrencias: dos apicales y ocho prolapsos rectales internos. Los síntomas de abultamiento (94% a 12%; p <0.0005), incontinencia fecal (62% a 32%; p <0.0005), obstrucción defecatoria (59% a 24%; p = 0.008) y puntajes promedio del cuestionario de impacto del piso pélvico (124 a 5; p = 0.022) mejoraron significativamente en el seguimiento final. Las puntuaciones medias del inventario de molestias urogenitales mostraron una mejoría después de un año (30 a 13; p = 0.021).Estudio observacional de centro único con imagenología postoperatoria selectiva.Noventa por ciento de los pacientes estaban libres de recurrencia 48 meses después de la sacrocolporectopexia asistida por robot. Los síntomas de abultamiento vaginal, la calidad de vida, el estreñimiento y la incontinencia fecal mejoraron significativamente. Sin embargo, un subgrupo de pacientes mostró molestias intestinales persistentes que subrayan a la complejidad del prolapso multicompartimental. Consulte Video Resumen en http://links.lww.com/DCR/B265.

Long-term mesh erosion rate following abdominal robotic reconstructive pelvic floor surgery: a prospective study and overview of the literature.

INTRODUCTION AND HYPOTHESIS: The use of synthetic mesh in transvaginal pelvic floor surgery has been subject to debate internationally. Although mesh erosion appears to be less associated with an abdominal approach, the long-term outcome has not been studied intensively. This study was set up to determine the long-term mesh erosion rate following abdominal pelvic reconstructive surgery. METHODS: A prospective, observational cohort study was conducted in a tertiary care setting. All consecutive female patients who underwent robot-assisted laparoscopic sacrocolpopexy and sacrocolporectopexy in 2011 and 2012 were included. Primary outcome was mesh erosion. Preoperative and postoperative evaluation (6 weeks, 1 year, 5 years) with a clinical examination and questionnaire regarding pelvic floor symptoms was performed. Mesh-related complications were assessed using a transparent vaginal speculum, proctoscopy, and digital vaginal and rectal examination. Kaplan-Meier estimates were calculated for mesh erosion. A review of the literature on mesh exposure after minimally invasive sacrocolpopexy was performed (≥12 months' follow-up). RESULTS: Ninety-six of the 130 patients included (73.8%) were clinically examined. Median follow-up time was 48.1 months (range 36.0-62.1). Three mesh erosions were diagnosed (3.1%; Kaplan-Meier 4.9%, 95% confidence interval 0-11.0): one bladder erosion for which mesh resection and an omental patch interposition were performed, and two asymptomatic vaginal erosions (at 42.7 and 42.3 months) treated with estrogen cream in one. Additionally, 22 patients responded solely by questionnaire and/or telephone; none reported mesh-related complaints. The literature, mostly based on retrospective studies, described a median mesh erosion rate of 1.9% (range 0-13.3%). CONCLUSIONS: The long-term rate of mesh erosion following an abdominally placed synthetic graft is low.

Learning curve of robot-assisted laparoscopic sacrocolpo(recto)pexy: a cumulative sum analysis.

BACKGROUND: Determination of the learning curve of new techniques is essential to improve safety and efficiency. Limited information is available regarding learning curves in robot-assisted laparoscopic pelvic floor surgery. OBJECTIVE: The purpose of this study was to assess the learning curve in robot-assisted laparoscopic pelvic floor surgery. STUDY DESIGN: We conducted a prospective cohort study. Consecutive patients who underwent robot-assisted laparoscopic sacrocolpopexy or sacrocolporectopexy were included (n=372). Patients were treated in a teaching hospital with a tertiary referral function for gynecologic/multicompartment prolapse. Procedures were performed by 2 experienced conventional laparoscopic surgeons (surgeons A and B). Baseline demographics were scored per groups of 25 consecutive patients. The primary outcome was the determination of proficiency, which was based on intraoperative complications. Cumulative sum control chart analysis allowed us to detect small shifts in a surgeon's performance. Proficiency was obtained when the first acceptable boundary line of cumulative sum control chart analysis was crossed. Secondary outcomes that were examined were shortening and/or stabilization of surgery time (measured with the use of cumulative sum control chart analysis and the moving average method). RESULTS: Surgeon A performed 242 surgeries; surgeon B performed 137 surgeries (n=7 surgeries were performed by both surgeons). Intraoperative complications occurred in 1.9% of the procedures. The learning curve never fell below the unacceptable failure limits and stabilized after 23 of 41 cases. Proficiency was obtained after 78 cases for both surgeons. Surgery time decreased after 24-29 cases in robot-assisted sacrocolpopexy (no distinct pattern for robot-assisted sacrocolporectopexy). Limitations were the inclusion of 2 interventions and concomitant procedures, which limited homogeneity. Furthermore, analyses treated all complications in cumulative sum as equal weight, although there are differences in the clinical relevance of complications. CONCLUSION: After 78 cases, proficiency was obtained. After 24-29 cases, surgery time stabilized for robot-assisted sacrocolpopexy. In this age of rapidly changing surgical techniques, it can be difficult to determine the learning curve of each procedure. Cumulative sum control chart analysis can assist with this determination and prove to be a valuable tool. Training programs could be individualized to improve both surgical performance and patient benefits.

Mesh Exposure After Robot-Assisted Laparoscopic Pelvic Floor Surgery: A Prospective Cohort Study.

STUDY OBJECTIVE: To prospectively evaluate the mesh exposure rate after robot-assisted laparoscopic pelvic floor surgery for the treatment of female pelvic organ prolapse (POP) in a large cohort. DESIGN: Prospective observational cohort study (Canadian Task Force classification II-2). SETTING: Two large teaching hospitals with a tertiary referral function for pelvic floor disorders. PATIENTS: Patients with symptomatic POP and simplified POP quantification (S-POP) stage ≥2. Patients with a history of mesh repair or concomitant insertion of a tension-free vaginal tape were excluded. INTERVENTIONS: Robot-assisted laparoscopic sacrocolpopexy or robot-assisted laparoscopic supracervical hysterectomy with a sacrocervicopexy. MEASUREMENTS AND MAIN RESULTS: A blinded vaginal examination with the aid of a transparent speculum was performed to look for mesh-related complications. Mesh exposures were described following the International Urogynecological Association/International Continence Society classification system. One hundred and ninety-two patients were included, of whom 166 (86.5%) were seen for follow-up examination. The median duration of follow-up was 15.7 months (range, 8.2-44.4 months). Two vaginal mesh exposures (1.2%) were detected, both of which were treated in the outpatient clinic. One patient without any complaints had a suture exposure, which was removed in the outpatient clinic. CONCLUSION: The safety of the use of mesh in pelvic floor surgery is a matter of debate owing to the occurrence of mesh-related complications. Based on the current literature, mesh-related complications seem to be lower in transabdominal mesh surgery than in transvaginal mesh surgery. In this study, a low mesh exposure rate was observed in robot-assisted abdominal pelvic floor surgery for POP.

Sexual function after robot-assisted prolapse surgery: a prospective study.

INTRODUCTION AND HYPOTHESIS: Female pelvic organ prolapse (POP) can severely influence sexual function. Robot-assisted surgery is increasingly used to treat POP, but studies describing its effect on sexual function are limited. The objective of this study was to evaluate sexual function after robot-assisted POP surgery. METHODS: This prospective cohort study included all patients who underwent a robot-assisted sacrocolpopexy (RASC) or supracervical hysterectomy with sacrocervicopexy (RSHS). Exclusion criteria were unknown preoperative sexual activity status or concomitant surgery. In sexually active women, sexual function was measured with the translated validated version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Changes in sexual activity were scored. Prolapse stages were described using the simplified Pelvic Organ Prolapse Quantification (S-POP) system. RESULTS: A total of 107 women were included (median follow-up 15.3 months). No difference was found in the total number of sexually active women before and after surgery [63 (58.9%) vs. 61 (63.5%), p = 0.999]. Significantly fewer women avoided sexual intercourse postoperatively compared with preoperatively. Preoperatively, sexual intercourse was avoided due to vaginal bulging (2% vs. 24%, respectively, p = 0.021). Total mean PISQ-12 scores improved significantly 1 year after prolapse correction (33.5 vs. 37.1; p = 0.004), mainly due to improved scores on the physical and behavioral-emotive domain. No significant difference in pre- and postoperative complains of dyspareunia was found. CONCLUSION: Robot-assisted middle-compartment surgery improved sexual function 1 year after surgery according to enhanced physical and emotional scores. The total number of sexually active women and complains of dyspareunia before and after surgery did not differ.

Robot-Assisted Sacrocolporectopexy for Multicompartment Prolapse of the Pelvic Floor: A Prospective Cohort Study Evaluating Functional and Sexual Outcome.

BACKGROUND: Pelvic floor disorders are a major public health issue. For female genital prolapse, sacrocolpopexy is the gold standard. Laparoscopic ventral mesh rectopexy is a relatively new and promising technique correcting rectal prolapse. There is no literature combining the 2 robotically assisted techniques. OBJECTIVE: This study was designed to evaluate the safety, quality of life, and functional and sexual outcomes of robot-assisted sacrocolporectopexy for multicompartment prolapse of the pelvic floor. DESIGN: This was a prospective, observational cohort study. SETTINGS: The study was conducted in a tertiary care setting. PATIENTS: All sexually active patients undergoing robot-assisted sacrocolporectopexy at our institution between 2012 and 2014 were included. INTERVENTION: Robot-assisted sacrocolporectopexy was the study intervention. MAIN OUTCOME MEASURES: Preoperative and postoperative (12 months) questionnaires using the Urinary Distress Inventory, Pescatori Incontinence Scale, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and Pelvic Floor Impact Questionnaire were completed. In addition Wexner and Vaizey incontinence scores and the Wexner constipation score were recorded postoperatively. RESULTS: Fifty-one patients underwent robot-assisted sacrocolporectopexy (median follow-up, 12.5 months). The simplified Pelvic Organ Prolapse Quantification improved significantly (p < 0.0005) for all 4 of the anatomic landmarks. Both median fecal (preoperative and postoperative Pescatori 4 vs 3, p = 0.002) and urinary incontinence scores (Urinary Distress Inventory, 27.8 vs 22.2; p < 0.0005) improved significantly at 12 months. Postoperatively median Wexner (3) and Vaizey incontinence (6) and Wexner Constipation (7) scores were noted. A positive effect on sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score 31.8 vs 35.9; p = 0.002) and quality of life for each compartment (p < 0.0005) was observed. One patient (2%) developed mesh erosion. No multicompartment recurrences were detected. LIMITATIONS: This was a observational study with a limited follow-up, no control group, and no preoperatively validated constipation score. CONCLUSIONS: Robot-assisted sacrocolporectopexy is a safe and effective technique for multicompartment prolapse in terms of functional outcome, quality of life, and sexual function.