Personalised electronic health programme for recovery after major abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.

BACKGROUND: Despite the adoption of minimally invasive techniques, recovery after abdominal surgery takes a long time. Electronic health (eHealth) modalities can provide guidance to patients, facilitating early return to normal activities. We aimed to assess the impact of a personalised eHealth programme on patients' return to normal activities after major abdominal surgery. METHODS: This single-blind, randomised, placebo-controlled trial was done at 11 teaching hospitals in the Netherlands. Eligible participants were aged 18-75 years who underwent a laparoscopic or open colectomy or hysterectomy. An independent researcher randomly allocated participants (in a 1:1 ratio) to either the intervention or control group by use of computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised eHealth programme consisting of both standard face-to-face care and eHealth, that comprised interactive tools offering goal attainment and a personalised outcome measurement, which managed recovery expectations and provided postoperative guidance tailored to each patient. Patients were provided with an activity tracker and had access to a website and mobile app with an electronic consultation (eConsult) functionality. The control group received standard care and access to a placebo website containing recovery advice provided by the hospital. The primary outcome was the number of days between surgery and personalised return to normal activities, assessed with Kaplan-Meier curves. Intention-to-treat and per-protocol analyses were done with a Cox regression model. This trial is registered with the Netherlands National Trial Register (NTR5686). FINDINGS: Between Feb 11, 2016, and Aug 9, 2017, 355 participants were randomly assigned to the intervention (n=178) or control (n=177) groups. 342 participants were included in the intention-to-treat analysis. The median time until return to normal activities was 52 days (IQR 33-111) in the intervention group, and 65 days (39-152) in the control group (adjusted hazard ratio 1·30 [95% CI 1·03-1·64]; p=0·027). The frequency of postoperative complications did not differ between groups. INTERPRETATION: This eHealth programme, delivering personalised care based on goal attainment scaling, enabled patients to return to their normal activities 13 days earlier than those who received standard care. FUNDING: ZonMw.

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.

Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development.

BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

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.

Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.

BACKGROUND: Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery. METHODS: A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699. FINDINGS: Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups. INTERPRETATION: A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures. FUNDING: ZonMw.

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.

Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation.

OBJECTIVE: To evaluate the implementation and effectiveness of an internet-based perioperative care programme for patients following gynaecological surgery for benign disease. DESIGN: Stepped-wedge cluster randomised controlled trial. SETTING: Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS: 433 employed women aged 18-65 years scheduled for hysterectomy and/or laparoscopic adnexal surgery. INTERVENTIONS: An internet-based care programme was sequentially rolled out using a multifaceted implementation strategy. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or the care programme (n=227). The care programme included an e-health intervention equipping patients with tailored personalised convalescence advice. MAIN OUTCOME MEASURES: The primary outcome was duration until full sustainable return to work (RTW). The degree of implementation of the care programme was evaluated at the level of the patient, healthcare provider and organisation by indicators measuring internet-based actions by patients and providers. RESULTS: Median time until RTW was 49 days (IQR 27-76) in the intervention group and 62 days (42-85) in the control group. A piecewise Cox model was fitted to take into account non-proportionality of hazards. In the first 85 days after surgery, patients receiving the intervention returned to work faster than patients in the control group (HR 2.66, 95% CI 1.88 to 3.77), but this effect was reversed in the small group of patients that did not reach RTW within this period (0.28, 0.17 to 0.46). Indicators showed that the implementation of the care programme was most successful at the level of the patient (82.8%) and professional (81.7%). CONCLUSIONS: Implementation of an internet-based care programme has a large potential to lead to accelerated recovery and improved RTW rates following different types of gynaecological surgeries. TRIAL REGISTRATION NUMBER: NTR2933; Results.

Training in Basic Laparoscopic Surgical Skills: Residents Opinion of the New Nintendo Wii-U Laparoscopic Simulator.

OBJECTIVE: Serious games are new in the field of laparoscopic surgical training. We evaluate the residents׳ opinion of a new laparoscopic simulator for the Nintendo Wii-U platform. DESIGN: Prospective questionnaire study. Participants received a standardized introduction and completed level 3 and 4 of the game "Underground." They filled out a questionnaire concerning demographics and their opinion on realism, usefulness, suitability, haptic feedback, and home training-use of the game. SETTING: Two tertiary teaching hospitals. PARTICIPANTS: Obstetrics and gynaecology residents postgraduate year 1 to 6 (n = 59) from several European countries. RESULTS: Subjects (n = 59) were divided into 2 groups based on laparoscopic experience: Group A (n = 38) and Group B (n = 21). The realism of different aspects of the game received mean scores around 3 on a 5-point Likert scale. The hand-eye coordination was regarded most useful for training with a mean of 3.92 (standard deviation 0.93) and the game was considered most suitable for residents in the first part of their postgraduate training with a mean of 3.73 (standard deviation 0.97). Both groups differed especially concerning their opinion of the usefulness of the game as a training tool. CONCLUSIONS: Most residents liked the new serious game for the Nintendo Wii-U. The usefulness and suitability as a laparoscopic training tool were rated at an acceptable to high level. However, the game does require improvements such as inclusion of a good scoring system before it can be integrated in resident training curricula.

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial.

BACKGROUND: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. OBJECTIVE: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. METHODS: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. RESULTS: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. CONCLUSIONS: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. CLINICALTRIAL: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy).

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.

The cost effectiveness of a tailored, web-based care program to enhance postoperative recovery in gynecologic patients in comparison with usual care: protocol of a stepped wedge cluster randomized controlled trial.

BACKGROUND: The length of recovery after benign gynecological surgery and return to work frequently exceeds the period that is recommended or expected by specialists. A prolonged recovery is associated with a poorer quality of life. In addition, costs due to prolonged sick leave following gynecological surgery cause a significant financial burden on society. OBJECTIVE: The objective of our study was to present the protocol of a stepped wedge cluster randomized controlled trial to evaluate the cost effectiveness of a new care program for patients undergoing hysterectomy and/or adnexal surgery for benign disease, compared to the usual care. METHODS: The care program under study, designed to improve convalescence and to prevent delayed return to work, targets two levels. At the hospital level, guidelines will be distributed among clinical staff in order to stimulate evidence-based patient education. At the patient level, additional perioperative guidance is provided by means of an eHealth intervention, equipping patients with tailored convalescence advice, and an occupational intervention is available for those patients at risk of prolonged sick leave. Due to the stepped wedge design of the trial, the care program will be sequentially rolled out among the 9 participating hospitals, from which the patients are recruited. Eligible for this study are employed women, 18-65 years of age, who are scheduled for hysterectomy and/or laparoscopic adnexal surgery. The primary outcome is full sustainable return to work. The secondary outcomes include general recovery, quality of life, self-efficacy, coping, and pain. The data will be collected by means of self-reported electronic questionnaires before surgery and at 2, 6, 12, 26, and 52 weeks after surgery. Sick leave and cost data are measured by monthly sick leave calendars, and cost diaries during the 12 month follow-up period. The economic evaluation will be performed from the societal perspective. All statistical analyses will be conducted according to the intention-to-treat principle. RESULTS: The enrollment of the patients started October 2011. The follow-up period will be completed in August 2014. Data cleaning or analysis has not begun as of this article's submission. CONCLUSIONS: We hypothesize the care program to be effective by means of improving convalescence and reducing costs associated with productivity losses following gynecological surgery. The results of this study will enable health care policy makers to decide about future implementation of this care program on a broad scale. TRIAL REGISTRATION: Netherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84).

[Placement of 'mesh' should be carefully considered]. / Weinig ruimte voor transvaginale matjes.

Transvaginal mesh placement has become a popular surgical treatment for prolapse. The space in which the mesh is positioned is created through an incision in the vaginal wall. The mesh is fixed in a semi-blind fashion by anchors. The number of complications reported has increased over the years; mesh erosion, which occurs in 4-19% of patients, is regarded as the most troublesome problem.

One-year follow-up after sacrospinous hysteropexy and vaginal hysterectomy for uterine descent: a randomized study.

INTRODUCTION AND HYPOTHESIS: In a retrospective study, the sacrospinous hysteropexy was associated with a shorter recovery time compared to a vaginal hysterectomy with no differences in anatomical outcomes. No randomized trials are performed. METHODS: Sixty-six women with stage 2-4 uterine descent were randomized for vaginal hysterectomy(31) or sacrospinous hysteropexy(35). Recovery time, anatomical outcomes, functional outcomes, and quality of life were measured. RESULTS: Length of time to return to work was shorter after a sacrospinous hysteropexy (43 versus 66 days, p = 0.02). The difference in risk for recurrent prolapse stage 2 or more of the apical compartment at 1-year follow-up was 17% (95% confidence interval, 2 to 30) in favor of the vaginal hysterectomy. No differences in quality of life and urogenital symptoms were found. CONCLUSIONS: The sacrospinous hysteropexy for uterine descent is associated with an earlier recovery time, more recurrent apical prolapses but no differences in functional outcomes, and quality of life.

Vaginal surgery for uterine descent; which options do we have? A review of the literature.

Several vaginal procedures are available for treating uterine descent. Vaginal hysterectomy is usually the surgeon's first choice. In this literature review, complications, anatomical and symptomatic outcomes, and quality of life after vaginal hysterectomy, sacrospinous hysteropexy, the Manchester procedure, and posterior intravaginal slingplasty are described. All procedures had low complication rates, except posterior intravaginal slingplasty, with a tape erosion rate of 0-21%. Minimal anatomical success rates regarding apical support ranged from 85% and 93% in favor of the Manchester procedure. Data on symptomatic cure and quality of life are scarce. In studies comparing vaginal hysterectomy with sacrospinous hysteropexy or the Manchester procedure, vaginal hysterectomy had higher morbidity. Because no randomized, controlled trials have been performed comparing these surgical techniques, we can not conclude that one of the procedures prevails. However, one can conclude from the literature that vaginal hysterectomy is not the logical first choice.

Serious complication 1 year after sacrospinous ligament fixation.

Myositis of the gluteal region caused by group A streptococci 1 year after a sacrospinous ligament fixation was recognised as a serious complication of this procedure. Most likely, the infection was spread to the gluteal region through a port d'entree caused by vaginal atrophy, via the non-resorbable sutures. The patient was treated successfully with antibiotics intravenous and local estrogens.