Evaluation of the learning curve of robot-assisted laparoscopic ventral mesh rectopexy.

BACKGROUND: The current standard treatment for external rectal prolapse and symptomatic high-grade internal rectal prolapse is surgical correction with minimally invasive ventral mesh rectopexy using either laparoscopy or robotic assistance. This study examines the number of procedures needed to complete the learning curve for robot-assisted ventral mesh rectopexy (RVMR) and reach adequate performance. METHODS: A retrospective analysis of all primary RVMR from 2011 to 2019 performed in a tertiary pelvic floor clinic by two colorectal surgeons (A and B) was performed. Both surgeons had previous experience with laparoscopic rectopexy, but no robotic experience. Skin-to-skin operating times (OT) were assessed using LC-CUSUM analyses. Intraoperative and postoperative complications were analyzed using CUSUM analyses. RESULTS: A total of 182 (surgeon A) and 91 (surgeon B) RVMRs were performed in total. There were no relevant differences in patient characteristics between the two surgeons. Median OT was 75 min (range 46-155; surgeon A) and 90 min (range 63-139; surgeon B). The learning curve regarding OT was completed after 36 procedures for surgeon A and 55 procedures for surgeon B. Both before and after completion of the learning curve, intraoperative and postoperative complication rates remained below a predefined acceptable level of performance. CONCLUSIONS: 36 to 55 procedures are required to complete the learning curve for RVMR. The implementation of robotic surgery does not inflict any additional risks on patients at the beginning of a surgeon's learning curve.

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.

Ninety-day morbidity of robot-assisted redo surgery for recurrent rectal prolapse, mesh erosion and pelvic pain: lessons learned from 9 years' experience in a tertiary referral centre.

AIM: With increasing follow-up of patients treated with minimally invasive ventral mesh rectopexy (VMR) more redo surgery can be expected for recurrent rectal prolapse, mesh erosion and pelvic pain. The aim of this study is to evaluate the 90-day morbidity of robot-assisted redo interventions. METHOD: All robot-assisted redo interventions after primary transabdominal repair of rectal prolapse between 2011 and 2019 were retrospectively analysed and compared with the results for patients after primary robot-assisted VMR during the same period. The redo interventions were divided into groups based on the indication for surgery (recurrent prolapse, mesh erosion, pelvic pain). Intraoperative complications and 90-day postoperative morbidity were evaluated. RESULTS: Three hundred and fifty nine patients were treated with primary VMR, with 73 for recurrent rectal prolapse, 12 for mesh erosion and 14 for pelvic pain. Complications of recurrent prolapse surgeries were comparable to those of primary VMR (p > 0.05). More intraoperative complications, minor and major complications were seen in redo surgery for erosion compared with primary VMR (23% vs. 3%, p = 0.01; 31% vs. 11%, p = 0.055; and 38% vs. 1%, p < 0.01 respectively). The frequency of intraoperative complications after redo surgery for pelvic pain was 7% with minor and major morbidity rates of 14% and 7% (p > 0.05). Half of the patients with pelvic pain experienced relief of their symptoms. CONCLUSION: Redo surgery for management of recurrent rectal prolapse is safe. Redo surgery for mesh erosion is associated with high morbidity rates. Redo surgery for pelvic pain can have major complications and is only effective in half of the cases.

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.

Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: 5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial).

OBJECTIVE: The aim of this study was to establish whether surgical or conservative treatment leads to a higher quality of life (QoL) in patients with recurring diverticulitis and/or ongoing complaints. SUMMARY OF BACKGROUND DATA: The 6 months' results of the DIRECT trial, a randomized trial comparing elective sigmoidectomy with conservative management in patients with recurring diverticulitis (>2 episodes within 2 years) and/or ongoing complaints (>3 months) after an episode of diverticulitis, demonstrated a significantly higher QoL after elective sigmoidectomy. The aim of the present study was to evaluate QoL at 5-year follow-up. METHODS: From January 2010 to June 2014, 109 patients were randomized to either elective sigmoidectomy (N = 53) or conservative management (N = 56). In the present study, the primary outcome was QoL measured by the Gastrointestinal Quality of Life Index (GIQLI) at 5-year follow-up. Secondary outcome measures were SF-36 score, Visual Analogue Score (VAS) pain score, EuroQol-5D-3L (EQ-5D-3L) score, morbidity, mortality, perioperative complications, and long-term operative outcome. RESULTS: At 5-year follow-up, mean GIQLI score was significantly higher in the operative group [118.2 (SD 21.0)] than the conservative group [108.5 (SD 20.0)] with a mean difference of 9.7 (95% confidence interval 1.7-17.7). All secondary QoL outcome measures showed significantly better results in the operative group, with a higher SF-36 physical (P = 0.030) and mental score (P = 0.010), higher EQ5D score (P = 0.016), and a lower VAS pain score (P = 0.011). Twenty-six (46%) patients in the conservative group ultimately required surgery due to severe ongoing complaints. Of the operatively treated patients, 8 (11%) patients had anastomotic leakage and reinterventions were required in 11 (15%) patients. CONCLUSION: Consistent with the short-term results of the DIRECT trial, elective sigmoidectomy resulted in a significantly increased QoL at 5-year follow-up compared with conservative management in patients with recurring diverticulitis and/or ongoing complaints. Surgeons should counsel these patients for elective sigmoidectomy weighing superior QoL, less pain, and lower risk of new recurrences against the complication risk of surgery.

Morbidity and mortality in complex robot-assisted hiatal hernia surgery: 7-year experience in a high-volume center.

INTRODUCTION: Published data regarding robot-assisted hiatal hernia repair are mainly limited to small cohorts. This study aimed to provide information on the morbidity and mortality of robot-assisted complex hiatal hernia repair and redo anti-reflux surgery in a high-volume center. MATERIALS AND METHODS: All patients that underwent robot-assisted hiatal hernia repair, redo hiatal hernia repair, and anti-reflux surgery between 2011 and 2017 at the Meander Medical Centre, Amersfoort, the Netherlands were evaluated. Primary endpoints were 30-day morbidity and mortality. Major complications were defined as Clavien-Dindo ≥ IIIb. RESULTS: Primary surgery 211 primary surgeries were performed by two surgeons. The median age was 67 (IQR 58-73) years. 84.4% of patients had a type III or IV hernia (10.9% Type I; 1.4% Type II; 45.5% Type III; 38.9% Type IV, 1.4% no herniation). In 3.3% of procedures, conversion was required. 17.1% of patients experienced complications. The incidence of major complications was 5.2%. Ten patients (4.7%) were readmitted within 30 days. Symptomatic early recurrence occurred in two patients (0.9%). The 30-day mortality was 0.9%. Redo surgery 151 redo procedures were performed by two surgeons. The median age was 60 (IQR 51-68) years. In 2.0%, the procedure was converted. The overall incidence of complications was 10.6%, while the incidence of major complications was 2.6%. Three patients (2.0%) were readmitted within 30 days. One patient (0.7%) experienced symptomatic early recurrence. No patients died in the 30-day postoperative period. CONCLUSIONS: This study provides valuable information on robot-assisted laparoscopic repair of primary or recurrent hiatal hernia and anti-reflux surgery for both patient and surgeon. Serious morbidity of 5.2% in primary surgery and 2.6% in redo surgery, in this large series with a high surgeon caseload, has to be outweighed by the gain in quality of life or relief of serious medical implications of hiatal hernia when counseling for surgical intervention.

Ergonomics in handheld and robot-assisted camera control: a randomized controlled trial.

BACKGROUND: Laparoscopic surgery potentially increases the physical burden to operating theater personnel and can cause physical discomfort. This study aims to evaluate if a robotic camera holder (AutoLap™ system) can improve ergonomics for the surgeon and the camera assistant during laparoscopic procedures. METHODS: A total of thirty cases were included and randomized (15 AutoLap™, 15 control). Five types of surgery were included: right hemicolectomy, fundoplication, sigmoid resection, rectopexy, and low anterior resection. The posture of the surgeon and assistant was photographed during predefined steps of the procedure. MATLAB was used to calculate angles relevant for the RULA score. The RULA score is a validated method to evaluate body posture, force and repetition of the upper extremities. Two investigators assessed the RULA score independently. Three subjective questionnaires (SMEQ, NASA TLX, and LED) were used to assess mental and physical discomfort. RESULTS: No differences in patient characteristics were observed. Sixteen fundoplications, seven right hemicolectomies, five sigmoid resections, one rectopexy, and one low anterior resection were included. The mean RULA score of the surgeon was comparable in both groups, 2.58 (AutoLap™) versus 2.72 (control). The mean RULA score of the assistant was significantly different in both groups, with 2.55 (AutoLap™) versus 3.70 (control) (p = 0.001). The inter-observer variability (ICC) was excellent with 0.93 (surgeon) and 0.97 (assistant). The questionnaires showed a significant difference in physical discomfort for the assistant. The LED and SMEQ score were significantly lower in the robotic group. The NASA TLX demonstrated a significant reduction in scores in all domains when using robotics with the exception of the mental domain. CONCLUSION: Use of the AutoLap™ system shows improvement in ergonomics and posture of the first assistant, and ergonomics of the surgeon are not affected. Furthermore, the subjective work load is significantly reduced by using a robotic camera holder. TRIAL REGISTRATION NUMBER: NCT0339960, https://clinicaltrials.gov/ct2/show/study/NCT03339960?term=autolap&rank=5 .

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.

Displaced Clavicle Fractures in Cyclists: Return to Athletic Activity After Anteroinferior Plate Fixation.

BACKGROUND: One of the most commonly observed injuries in cycling is fracture of the clavicle. Nevertheless, there is limited literature available on clinical outcomes after plate fixation of clavicle fractures in cyclists, rehabilitation protocols, and the time to return to sports. PURPOSE: The aim of this study was to evaluate the functional outcome, complications, and return to athletic activity at short-term follow-up after surgical repair. STUDY DESIGN: Case series. METHODS: Between January 2008 and October 2014, all professional and recreational cyclists presenting with a new clavicle fracture at the emergency department were prospectively recorded. All patients had an anteroinferior plate fixation, variable angle locking compression plate (DePuySynthes). Patients were seen at 2, 6, and 24 weeks at the outpatient clinic to gather Disability of the Arm, Shoulder, and Hand (DASH) and Constant shoulder questionnaires and radiographs were made. Cyclists were allowed to resume outside training 1 week after surgery. RESULTS: Ten professional cyclists and 15 recreational cyclists were included. All (25/25) patients returned to cycling after plate fixation. Mean Constant scores and mean DASH scores of 96.8 ± 4.1 and 5.1 ± 5.5 at 6 weeks and 99.1 ± 1.5 and 2.9 ± 4.6 at 24 weeks were measured. There were 3 complications: 1 patient developed a nonunion, there was 1 wound infection requiring antibiotics, and in 1 patient, a refracture occurred. CONCLUSION: Plate fixation for cyclists with displaced clavicle fractures was successful in terms of fast return to previous level of athletic activity. It is a valuable and safe option for athletes in cycling.

Extent of unnecessary surgery for benign rectal polyps in the Netherlands.

BACKGROUND AND AIMS: Minimally invasive techniques are available to safely and efficaciously remove even the largest rectal polyps. This study aimed to investigate the magnitude of cases still referred for radical rectal surgery and the reasons for these referrals and to perform a re-evaluation of cases potentially suitable for endoscopic therapy. METHODS: A retrospective analysis of data from the Dutch Pathology Registry (Pathologic Anatomic Nationwide Automated Archive) was performed using the records of patients who underwent major surgical treatment for a histologically proven benign rectal polyp between 2005 and 2014 in the Netherlands. In a representative subset of 7 hospitals, detailed analysis was performed. An expert panel of 3 endoscopists reassessed all patient data to judge whether endoscopic treatment would have been a reasonable alternative. RESULTS: In the last decade 575 patients, and 56 patients in the subset of hospitals, were referred for major rectal surgery for a benign rectal polyp in the Netherlands. The number of radical resections declined over the years but stabilized in the last years. The main reasons for surgery were polyp size (34%), suspicion of malignancy (34%), and transanal endoscopic microsurgery failures (20%). In community hospitals, referrals for surgery were relatively more prevalent compared with academic hospitals (P < .01). Thirty-nine percent of patients had perioperative adverse events, and 1 patient (1.8%) died. Seventy-three percent of cases were assessed as "probably feasible" for endoscopic therapy. CONCLUSIONS: Over the last 10 years the rate of radical rectal surgery for a benign polyp declined. However, a significant subgroup of patients was still referred for invasive surgery at the cost of high morbidity and mortality. Referral to an expert endoscopist may avoid unnecessary surgery in most cases.

Development and validation of a diagnostic prediction model distinguishing complicated from uncomplicated diverticulitis.

OBJECTIVES: Most diverticulitis patients (80%) who are referred to secondary care have uncomplicated diverticulitis (UD) which is a self-limiting disease and can be treated at home. The aim of this study is to develop a diagnostic model that can safely rule out complicated diverticulitis (CD) based on clinical and laboratory parameters to reduce unnecessary referrals. METHODS: A retrospective cross-sectional study was performed including all patients who presented at the emergency department with CT-proven diverticulitis. Patient characteristics, clinical signs and laboratory parameters were collected. CD was defined as > Hinchey 1A. Multivariable logistic regression analyses were used to quantify which (combination of) variables were independently related to the presence or absence of CD. A diagnostic prediction model was developed and validated to rule out CD. RESULTS: A total of 943 patients were included of whom 172 (18%) had CD. The dataset was randomly split into a derivation and validation set. The derivation dataset contained 475 patients of whom 82 (18%) patients had CD. Age, vomiting, generalized abdominal pain, change in bowel habit, abdominal guarding, C-reactive protein and leucocytosis were univariably related to CD. The final validated diagnostic model included abdominal guarding, C-reactive protein and leucocytosis (AUC 0.79 (95% CI 0.73-0.84)). At a CD risk threshold of ≤7.5% this model had a negative predictive value of 96%. CONCLUSION: This proposed prediction model can safely rule out complicated diverticulitis. Clinical practitioners could cautiously use this model to aid them in the decision whether or not to subject patients to further secondary care diagnostics or treatment.

First experience with THE AUTOLAP™ SYSTEM: an image-based robotic camera steering device.

BACKGROUND: Robotic camera holders for endoscopic surgery have been available for 20 years but market penetration is low. The current camera holders are controlled by voice, joystick, eyeball tracking, or head movements, and this type of steering has proven to be successful but excessive disturbance of surgical workflow has blocked widespread introduction. The Autolap™ system (MST, Israel) uses a radically different steering concept based on image analysis. This may improve acceptance by smooth, interactive, and fast steering. These two studies were conducted to prove safe and efficient performance of the core technology. METHODS: A total of 66 various laparoscopic procedures were performed with the AutoLap™ by nine experienced surgeons, in two multi-center studies; 41 cholecystectomies, 13 fundoplications including hiatal hernia repair, 4 endometriosis surgeries, 2 inguinal hernia repairs, and 6 (bilateral) salpingo-oophorectomies. The use of the AutoLap™ system was evaluated in terms of safety, image stability, setup and procedural time, accuracy of imaged-based movements, and user satisfaction. RESULTS: Surgical procedures were completed with the AutoLap™ system in 64 cases (97%). The mean overall setup time of the AutoLap™ system was 4 min (04:08 ± 0.10). Procedure times were not prolonged due to the use of the system when compared to literature average. The reported user satisfaction was 3.85 and 3.96 on a scale of 1 to 5 in two studies. More than 90% of the image-based movements were accurate. No system-related adverse events were recorded while using the system. CONCLUSION: Safe and efficient use of the core technology of the AutoLap™ system was demonstrated with high image stability and good surgeon satisfaction. The results support further clinical studies that will focus on usability, improved ergonomics and additional image-based features.

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 Ventral Mesh Rectopexy for Rectal Prolapse: A 5-Year Experience at a Tertiary Referral Center.

BACKGROUND: Laparoscopic ventral mesh rectopexy is being increasingly performed internationally to treat rectal prolapse syndromes. Robotic assistance appears advantageous for this procedure, but literature regarding robot-assisted ventral mesh rectopexy is limited. OBJECTIVE: The primary objective of this study was to assess the safety and effectiveness of robot-assisted ventral mesh rectopexy in the largest consecutive series of patients to date. DESIGN: This study is a retrospective cross-sectional analysis of prospectively collected data. SETTINGS: The study was conducted in a tertiary referral center. PATIENTS: All of the patients undergoing robot-assisted ventral mesh rectopexy for rectal prolapse syndromes between 2010 and 2015 were evaluated. MAIN OUTCOME MEASURES: Preoperative and postoperative (mesh and nonmesh) morbidity and functional outcome were analyzed. The actuarial recurrence rates were calculated using the Kaplan-Meier method. RESULTS: A total of 258 patients underwent robot-assisted ventral mesh rectopexy (mean ± SD follow-up = 23.5 ± 21.8 mo; range, 0.2 - 65.1 mo). There were no conversions and only 5 intraoperative complications (1.9%). Mortality (0.4%) and major (1.9%) and minor (<30 d) early morbidity (7.0%) were acceptably low. Only 1 (1.3%) mesh-related complication (asymptomatic vaginal mesh erosion) was observed. A significant improvement in obstructed defecation (78.6%) and fecal incontinence (63.7%) were achieved for patients (both p < 0.0005). At final follow-up, a new onset of fecal incontinence and obstructed defecation was induced or worsened in 3.9% and 0.4%. The actuarial 5-year external rectal prolapse and internal rectal prolapse recurrence rates were 12.9% and 10.4%. LIMITATIONS: This was a retrospective study including patients with minimal follow-up. No validated scores were used to assess function. The study was monocentric, and there was no control group. CONCLUSIONS: Robot-assisted ventral mesh rectopexy is a safe and effective technique to treat rectal prolapse syndromes, providing an acceptable recurrence rate and good symptomatic relief with minimal morbidity. See Video Abstract at http://links.lww.com/DCR/A427.

Efficacy of loop colostomy construction for acute left-sided colonic obstructions: a cohort analysis.

PURPOSE: Acute primary resection as treatment for left-sided colonic obstruction (LSCO) is notorious for its high morbidity and mortality rates. Both stenting and loop colostomy construction can serve as a bridge to surgery, hereby avoiding the high morbidity and mortality rates associated with emergency resections. This study aims to investigate the safety of a loop colostomy in patients presenting with acute LSCO. METHODS: Retrospective analysis of all patients that received a loop colostomy for LSCO between 2003 and 2015 was performed. Primary outcomes were mortality, major morbidity (Clavien-Dindo grades III-IV) and minor morbidity (Clavien-Dindo grades I-II). RESULTS: One hundred forty-six patients presenting with acute LSCO received a diverting colostomy. After colostomy construction, mortality occurred in four patients (2.7%) and major complications were reported in 20 patients (13.7%). In 61 patients, the diverting colostomy served as a palliative measure, because of metastatic disease or unfitness for major surgery. The remaining 85 patients all underwent delayed resection, resulting in an overall mortality, major morbidity and minor morbidity of 6.9% (n = 6), 14.0% (n = 12) and 26.7% (n = 23), respectively. CONCLUSIONS: Diverting colostomy construction is a minimally invasive and safe treatment option for LSCO. It can serve as a definite palliative measure, as well as a bridge to elective surgery. A diverting colostomy as a bridge to surgery might even be a valid alternative for emergency resections, since mortality and morbidity rates following colostomy construction and delayed resection appear lower than reported outcomes following primary resection.

Robotic-assisted flexible colonoscopy: preliminary safety and efficiency in humans.

BACKGROUND AND AIMS: The flexible endoscope is used as a platform for minimally invasive interventions. However, control of the conventional endoscope and multiple instruments is difficult. Robotic assistance could provide a solution and better control for a single operator. A novel platform should also enable interventions in areas that are currently difficult to reach. This study evaluates the safety and efficacy of a robotic platform that guides a conventional endoscope through the large bowel. METHODS: Adult patients scheduled for routine diagnostic colonoscopy were included in this feasibility study. The endoscope was introduced using a robotic add-on to provide tip bending and air/water actuation. The endoscopist directly controlled the endoscope shaft. Upon cecal intubation, the add-on was detached and the procedure continued using conventional control. Primary evaluation parameters were the number of serious adverse events and the percentage of successful cecal intubations. RESULTS: The procedure was performed on 22 consecutive patients who all gave informed consent. There were no serious adverse events. Cecal intubation was successful in 15 patients (68%) using the robotic add-on. Six cases were completed after conversion to conventional control: 3 cases were converted to pass sharp angulation in the flexures and 3 cases were converted after technical difficulties. One case was not successful with either technique because of severe diverticulosis. CONCLUSIONS: The robotic add-on steering module allows safe endoscope intubation to reach intervention sites throughout the large bowel. The next step is to clinically evaluate complementary instrument and shaft-guiding modules in therapeutic procedures.

Colonoscopy with robotic steering and automated lumen centralization: a feasibility study in a colon model.

BACKGROUND AND STUDY AIMS: We introduced a new platform for performing colonoscopy with robotic steering and automated lumen centralization (RS-ALC) and evaluated its technical feasibility. PARTICIPANTS AND METHODS: Expert endoscopists (n = 8) and endoscopy-naive novices (n = 10) used conventional steering and RS-ALC to perform colonoscopy in a validated colon model with simulated polyps (n = 21). The participants were randomized to which modality they were to use first. End points were the cecal intubation time, number of detected polyps, and subjective evaluation of the platform. RESULTS: Novices were able to intubate the cecum faster with RS-ALC (median 8 minutes [min] 56 seconds [s], interquartile range [IQR] 6  min 46  s - 16  min 34  s vs. median 11  min 47  s, IQR 8  min 19  s - 15  min 33  s, P = 0.65), whereas experts were faster with conventional steering (median 2  min 9  s, IQR 1  min 13 s - 7  min 28  s vs. median 13  min 1  s, IQR 5  min 9 s - 16  min 54  s, P = 0.12). Novices detected more polyps with RS-ALC (median 88.1 %, IQR 79.8 % - 95.2 % vs. median 78.6 %, IQR 75.0 % - 91.7 %, P = 0.17), whereas experts detected more polyps with conventional steering (median 80.9 %, IQR 76.2 % - 85.7 % vs. median 69.0 %, IQR 61.0 % - 75.0 %, P = 0.03). Novices were more positive than experts about the new platform (P = 0.02), noting an easier and faster introduction of the colonoscope with RS-ALC than with conventional steering. CONCLUSIONS: Colonoscopy with RS-ALC is technically feasible and appears to be easier and more intuitive than conventional steering for endoscopy-naive novices.

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.

Long-term Outcome After Laparoscopic Ventral Mesh Rectopexy: An Observational Study of 919 Consecutive Patients.

OBJECTIVE: This multicenter study aims to assess long-term functional outcome, early and late (mesh-related) complications, and recurrences after laparoscopic ventral mesh rectopexy (LVR) for rectal prolapse syndromes in a large cohort of consecutive patients. BACKGROUND: Long-term outcome data for prolapse repair are rare. A high incidence of mesh-related problems has been noted after transvaginal approaches using nonresorbable meshes. METHODS: All patients treated with LVR at the Meander Medical Centre, Amersfoort, the Netherlands and the University Hospital Leuven, Belgium between January 1999 and March 2013 were enrolled in this study. All data were retrieved from a prospectively maintained database. Kaplan-Meier estimates were calculated for recurrences and mesh-related problems. RESULTS: 919 consecutive patients (869 women; 50 men) underwent LVR. A 10-year recurrence rate of 8.2% (95% confidence interval, 3.7-12.7) for external rectal prolapse repair was noted. Mesh-related complications were recorded in 18 patients (4.6%), of which mesh erosion to the vagina occurred in 7 patients (1.3%). In 5 of these patients, LVR was combined with a perineotomy. Both rates of fecal incontinence and obstructed defecation decreased significantly (P < 0.0001) after LVR compared to the preoperative incidence (11.1% vs 37.5% for incontinence and 15.6% vs 54.0% for constipation). CONCLUSIONS: LVR is safe and effective for the treatment of different rectal prolapse syndromes. Long-term recurrence rates are in line with classic types of mesh rectopexy and occurrence of mesh-related complications is rare.