Predictors of Decreased Quality of Life in Breast Cancer Survivors Five Years After Diagnosis.

PURPOSE: Due to improved therapy, early diagnosis, and growing incidence rates, the number of long-term breast cancer survivors is increasing. Survivors can still be affected by aftercare, resulting in reduced quality of life (QoL). Thus, in this study, we investigated possible predictors of decreased physical and social functioning in breast cancer survivors. METHODS: In a German multicenter prospective study, we enrolled 759 female patients with breast cancer before surgery (t1), and contacted them again 5 years after surgery (t4). Data on QoL were assessed at t4 using the European Organization for Research and Treatment of Cancer QoL Core Questionnaire (EORTC QLQ-C30) and its breast cancer module EORTC QLQ-BR23. Predictors of decreased physical and social functioning were analyzed using logistic regression with odds ratios as effect estimates and 95% confidence intervals. Thresholds for the clinical importance of detrimental effects on QoL were defined according to Giesinger. RESULTS: Questionnaires from 759 patients were retrieved at t1. Of these, 456 participated in the study at t4. Poor QoL 5 years after diagnosis was reported by 20%-50% of the participants. Age, mastectomy, chemotherapy, education, employment, cohabitation, psychiatric comorbidities at t1, anxiety, depression, and intensity of physical activity emerged as predictors of decreased physical and social functioning 5 years after diagnosis. CONCLUSION: Relief of symptoms and improvement in the QoL should be priorities in aftercare. Detecting patients with a decreased QoL is a rising challenge. Healthcare providers should take special care of patients aged 50-59 years, patients with psychiatric comorbidities and depression, and patients who have undergone mastectomy.

Robot-assisted pelvic floor reconstructive surgery: an international Delphi study of expert users.

BACKGROUND: Robotic surgery has gained popularity for the reconstruction of pelvic floor defects. Nonetheless, there is no evidence that robot-assisted reconstructive surgery is either appropriate or superior to standard laparoscopy for the performance of pelvic floor reconstructive procedures or that it is sustainable. The aim of this project was to address the proper role of robotic pelvic floor reconstructive procedures using expert opinion. METHODS: We set up an international, multidisciplinary group of 26 experts to participate in a Delphi process on robotics as applied to pelvic floor reconstructive surgery. The group comprised urogynecologists, urologists, and colorectal surgeons with long-term experience in the performance of pelvic floor reconstructive procedures and with the use of the robot, who were identified primarily based on peer-reviewed publications. Two rounds of the Delphi process were conducted. The first included 63 statements pertaining to surgeons' characteristics, general questions, indications, surgical technique, and future-oriented questions. A second round including 20 statements was used to reassess those statements where borderline agreement was obtained during the first round. The final step consisted of a face-to-face meeting with all participants to present and discuss the results of the analysis. RESULTS: The 26 experts agreed that robotics is a suitable indication for pelvic floor reconstructive surgery because of the significant technical advantages that it confers relative to standard laparoscopy. Experts considered these advantages particularly important for the execution of complex reconstructive procedures, although the benefits can be found also during less challenging cases. The experts considered the robot safe and effective for pelvic floor reconstruction and generally thought that the additional costs are offset by the increased surgical efficacy. CONCLUSION: Robotics is a suitable choice for pelvic reconstruction, but this Delphi initiative calls for more research to objectively assess the specific settings where robotic surgery would provide the most benefit.

A 3D printed model of the female pelvis for practical education of gynecological pelvic examination.

BACKGROUND: Pelvic palpation is a core component of every Gynecologic examination. It requires vigorous training, which is difficult due to its intimate nature, leading to a need of simulation. Up until now, there are mainly models available for mere palpation which do not offer adequate visualization of the concerning anatomical structures. In this study we present a 3D printed model of the female pelvis. It can improve both the practical teaching of gynecological pelvic examination for health care professionals and the spatial understanding of the relevant anatomy. METHODS: We developed a virtual, simplified model showing selected parts of the female pelvis. 3D printing was used to create a physical model. RESULTS: The life-size 3D printed model has the ability of being physically assembled step by step by its users. Consequently, it improves teaching especially when combining it with commercial phantoms, which are built solely for palpation training. This is achieved by correlating haptic and visual sensations with the resulting feedback received. CONCLUSION: The presented 3D printed model of the female pelvis can be of aid for visualizing and teaching pelvic anatomy and examination to medical staff. 3D printing provides the possibility of creating, multiplying, adapting and sharing such data worldwide with little investment of resources. Thus, an important contribution to the international medical community can be made for training this challenging examination.

Introducing a novel model for simulating large loop excision of the transformation zone (LLETZ) using 3D printing technique.

PURPOSE: Electrosurgery is the gold-standard procedure for the treatment of cervical dysplasia. The quality of the outcome depends on the accuracy of performance, which underlines the role of adequate training of surgeons, especially, as this procedure is often performed by novice surgeons. According to our knowledge, medical simulation has up until now lacked a model, which focuses on realistically simulating the treatment of cervical dysplasia with the concerning anatomy. METHODS AND RESULT: In our work, we present a model created using 3D printing for holistically simulating diagnostic, as well as surgical interventions of the cervix, as realistically as possible. CONCLUSION: This novel simulator is compared to an existing model and both are evaluated. By doing so, we aim to provide novice gynecologists with standardized and high-quality simulation models for practicing to improve their proficiency.

BRENDA-Score, a Highly Significant, Internally and Externally Validated Prognostic Marker for Metastatic Recurrence: Analysis of 10,449 Primary Breast Cancer Patients.

Background Current research in breast cancer focuses on individualization of local and systemic therapies with adequate escalation or de-escalation strategies. As a result, about two-thirds of breast cancer patients can be cured, but up to one-third eventually develop metastatic disease, which is considered incurable with currently available treatment options. This underscores the importance to develop a metastatic recurrence score to escalate or de-escalate treatment strategies. Patients and methods Data from 10,499 patients were available from 17 clinical cancer registries (BRENDA-project [1]. In total, 8566 were used to develop the BRENDA-Index. This index was calculated from the regression coefficients of a Cox regression model for metastasis-free survival (MFS). Based on this index, patients were categorized into very high, high, intermediate, low, and very low risk groups forming the BRENDA-Score. Bootstrapping was used for internal validation and an independent dataset of 1883 patients for external validation. The predictive accuracy was checked by Harrell's c-index. In addition, the BRENDA-Score was analyzed as a marker for overall survival (OS) and compared to the Nottingham prognostic score (NPS). Results: Intrinsic subtypes, tumour size, grading, and nodal status were identified as statistically significant prognostic factors in the multivariate analysis. The five prognostic groups of the BRENDA-Score showed highly significant (p < 0.001) differences regarding MFS:low risk: hazard ratio (HR) = 2.4, 95%CI (1.7-3.3); intermediate risk: HR = 5.0, 95%CI.(3.6-6.9); high risk: HR = 10.3, 95%CI (7.4-14.3) and very high risk: HR = 18.1, 95%CI (13.2-24.9). The external validation showed congruent results. A multivariate Cox regression model for OS with BRENDA-Score and NPS as covariates showed that of these two scores only the BRENDA-Score is significant (BRENDA-Score p < 0.001; NPS p = 0.447). Therefore, the BRENDA-Score is also a good prognostic marker for OS. Conclusion: The BRENDA-Score is an internally and externally validated robust predictive tool for metastatic recurrence in breast cancer patients. It is based on routine parameters easily accessible in daily clinical care. In addition, the BRENDA-Score is a good prognostic marker for overall survival. Highlights: The BRENDA-Score is a highly significant predictive tool for metastatic recurrence of breast cancer patients. The BRENDA-Score is stable for at least the first five years after primary diagnosis, i.e., the sensitivities and specificities of this predicting system is rather similar to the NPI with AUCs between 0.76 and 0.81 the BRENDA-Score is a good prognostic marker for overall survival.

Laparoscopic Management of a Heterotopic Pregnancy in the Tubal Stump.

STUDY OBJECTIVE: To demonstrate how a heterotopic tubal stump pregnancy can be safely managed with laparoscopy, preserving the intrauterine pregnancy. DESIGN: Stepwise demonstration of the technique by means of a video tutorial. SETTING: The management of pregnancies in the tubal stump after salpingectomy involves either a surgical intervention or systemic therapy. In case of a simultaneous intrauterine pregnancy, although the prognosis for the fetus remains good with live births in approximately 70% of the cases, the surgical management of the tubal stump pregnancy is challenging owing to the risk of bleeding from the uterine horn [1-5]. We present an effective and reproducible laparoscopic technique on the basis of a 31-year-old patient with 2 prior right fallopian tube pregnancies, which were later treated with salpingectomy. The patient is now presenting in the sixth week of gestation after transfer from 2 oocytes with a pregnancy in the tubal stump and a concomitant vital intrauterine pregnancy. INTERVENTIONS: The key steps of laparoscopic surgery include (1) continuous absorbable monofilament suture on the uterine horn around the tubal stump to achieve hemostasis and exposure of the proximal part of the tube, (2) removal of ectopic pregnancy, and (3) closure of the excision site with continuous absorbable polyfilament suture. The instillation of vasoconstrictive substances and the use of electrical coagulation should be avoided. CONCLUSION: The demonstrated laparoscopic technique is a feasible method of removal of a tubal stump pregnancy without interfering with the vital intrauterine pregnancy. The blood loss can be minimized, and laparotomy can be avoided.

Implementation of robotic gynecological surgery in a German University Hospital: patient safety after 110 procedures.

PURPOSE: Robotic surgery represents the latest development in the field of minimally invasive surgery and offers many technical advantages. Despite the higher costs, this novel approach has been applied increasingly in gynecological surgery. Regarding the implementation of a new operative method; however, the most important factor to be aware of is patient safety. In this study, we describe our experience in implementing robotic surgery in a German University Hospital focusing on patient safety after 110 procedures. METHODS: We performed a retrospective analysis of 110 consecutive robotic procedures performed in the University Hospital of Würzburg between June 2017 and September 2019. During this time, 37 patients were treated for benign general gynecological conditions, 27 patients for gynecological malignancies, and 46 patients for urogynecological conditions. We evaluated patient safety through standardized assessment of intra- and postoperative complications, which were categorized according to the Clavien-Dindo classification. RESULTS: No complications were recorded in 90 (81.8%) operations. We observed Clavien-Dindo grade I complications in 8 (7.3%) cases, grade II complications in 5 (4.5%) cases, grade IIIa complications in 1 case (0.9%), and grade IIIb complications in 6 (5.5%) cases. No conversion to laparotomy or blood transfusion was needed. CONCLUSION: Robotic surgery could be implemented for complex gynecological operations without relevant problems and was accompanied by low complication rates.

Influence of Patient's Age on the Outcome of Vaginal and Laparoscopic Procedures in Urogynaecology.

Introduction In the treatment of prolapse and incontinence, the choice of surgical procedure often depends not only on the clinical findings but also on the age of the patient. Uncertainty exists at present regarding the effect of patient age on treatment outcomes for both vaginal and laparoscopic procedures. The aim of this study is therefore to compare both the anatomical outcome after prolapse surgery and the functional outcome after incontinence surgery in the context of the treatment of stress urinary incontinence in older and younger patients. Patients/Methods This is a retrospective single-centre study conducted at a university site. Over the study period, a total of 407 women underwent surgery, 278 of whom were < 70 and 129 ≥ 70 years of age. They were assigned to one of three treatment groups (prolapse surgery, incontinence surgery or a combination of both types of surgery) and were then subjected to statistical analysis after assessment of the anatomical and functional outcome after 3 - 6 months. Results The most common form of prolapse among the 407 evaluated patients was in the anterior and middle compartment, with a higher degree of severity being diagnosed in the older patients. Grade 4 prolapse according to the Baden-Walker system was thus present in the anterior compartment in 15.6 vs. 28.8% (p = 0.033) and in the middle compartment in 5.7 vs. 23.7% (p < 0.001) of cases. Younger women underwent vaginal mesh implantation less frequently and laparoscopic sacropexy more frequently for this overall. The proportion of cases of combined prolapse and incontinence surgery was the same in both groups. Overall, high success rates were observed in both younger and older patients following prolapse and incontinence surgery. These rates were 93.5 vs. 84.8% (p = 0.204) after prolapse surgery and 92.8 vs. 84.2% (p = 0.261) after incontinence surgery. A significant disadvantage for the older patients was the persistence of stress urinary incontinence after prolapse surgery alone (19.6 vs. 50%, p = 0.030) and the rate of occult (de novo) stress urinary incontinence (7.4 vs. 20%, p = 0.030). Conclusion Our data show that both pelvic organ prolapse and stress urinary incontinence can be treated with surgery with good results in women aged ≥ 70 years. It was thus possible to show for the first time in a large patient population that older women should not be denied appropriate surgery but can be offered the same range of surgical options as younger patients.

The Role of Deconstructive Teaching in the Training of Laparoscopy.

BACKGROUND AND OBJECTIVES: Skills-lab training is crucial for the development of advanced laparoscopic skills. In this study, we examined whether a systematic deconstructive and comprehensive tutoring approach improves training results in laparoscopic suturing and intracorporeal knot tying. METHODS: Sixteen residents in obstetrics and gynecology participating in structured skills-lab laparoscopy training were randomized in 2 equal-sized groups receiving 1-on-1 tutoring either in the traditional method or according to the Peyton's 4-step approach, involving an additional training step, with the trainees instructing the tutor to perform the exercises. A validated assessment tool (revised Objective Structured Assessment of Technical Skills) and the number of completed square knots per training session and the mean time per knot were used to assess the efficacy of training in both groups. RESULTS: Trainees in Peyton's group achieved significantly higher revised Objective Structured Assessment of Technical Skills scores (28.6 vs 23.9 points; P = .05) and were able to improve their scores during autonomous training repetitions, in contrast to the trainees not in Peyton's group (difference +4.75 vs -4.29 points, P = .02). Additionally, they seemed to be able to perform a greater number of successful knots during the exercise and to complete each knot quicker with the later observations failing to reach the threshold of statistical significance. CONCLUSION: Peyton's 4-step approach seemed to be superior for teaching laparoscopic skills to obstetrics and gynecology residents in the skills-lab setting and can be therefore proposed for training curricula.

Does chemotherapy improve survival in patients with nodal positive luminal A breast cancer? A retrospective Multicenter Study.

BACKGROUND: In this study based on the BRENDA data, we investigated the impact of endocrine ± chemotherapy for luminal A, nodal positive breast cancer on recurrence free (RFS) and overall survival (OS). In addition, we analysed if tumor size of luminal A breast cancer influences survival in patients with the same number of positive lymph nodes. METHODS: In this retrospective multi-centre cohort study data of 1376 nodal-positive patients with primary diagnosis of luminal A breast cancer during 2001-2008 were analysed. The results were stratified by therapy and adjusted by age, tumor size and number of affected lymph nodes. RESULTS: In our study population, patients had a good to excellent prognosis (5-year RFS: 91% and tumorspecific 5-year OS 96.5%). There was no significant difference in RFS stratified by patients with only endocrine therapy and with endocrine plus chemo-therapy. Patients with 1-3 affected lymph nodes had no significant differences in OS treated only with endocrine therapy or with endocrine plus chemotherapy, independent of tumor size. Patients with large tumors and more than 3 affected lymph nodes had a significant worse survival as compared to the small tumors. However, despite the worse prognosis of those, adjuvant chemotherapy failed in order to improve RFS. CONCLUSIONS: According to our data, nodal positive patients with luminal A breast cancer have, if any, a limited benefit of adjuvant chemotherapy. Tumor size and nodal status seem to be of prognostic value in terms of survival, however both tumor size as well as nodal status were not predictive for a benefit of adjuvant chemotherapy.

Instrument usage in laparoscopic gynecologic surgery: a prospective clinical trial.

PURPOSE: To evaluate instrumental usage in laparoscopic gynecological surgeries and to develop key timesets of a laparoscopic operation, which allows categorization of the operation time into different sections. METHODS: In this prospective clinical observational study, frequency of instrument usage, time for instrument switches, and instrument utilization time were recorded in a standardized manner for laparoscopic surgeries in 103 endoscopic surgeries. RESULTS: A standard equipment (including atraumatic grasping forceps, irrigation and suction device, bipolar clamp, and laparoscopic scissors) was used for nearly all interventions. Bipolar clamps and scissors were changed most frequently. The tool used for the longest amount of time was the atraumatic grasping forceps. Laparoscopic instruments were switched 51 times per surgery (range 2-250 times). One instrument switch lasted for a median of 0.13 min (0.08-1.2 min). Median time for instrument switch for a single surgery added up to 6.83 min. Instrument switches required 10.5% of the overall operation time. CONCLUSION: We analyzed the current instrument usage in laparoscopic gynecological surgeries. The results of our standardized investigation suggest ways to reduce the time required for surgery and provide starting points for the standardization of the work routine.

A randomized double-blind controlled trial of different filling pressures in operative outpatient hysteroscopy.

OBJECTIVE: To identify the optimal filling pressure during operative outpatient hysteroscopy that allows completion of the procedure while minimizing pain. METHODS: A double-blind randomized controlled trial of women aged 20-60 years undergoing operative hysteroscopy (including biopsy sampling, polypectomy, septum excision, adhesiolysis, or intrauterine device removal) was undertaken at a university hospital in Egypt between May 2014 and July 2016. Using a computer-generated randomization sequence, patients were randomly assigned into three equal groups: filling pressures of 40 mm Hg (group 1), 60 mm Hg (group 2), and 80 mm Hg (group 3; control). The primary outcome was the proportion of successfully completed procedures. Analyses were by intention to treat. RESULTS: Each group contained 80 women. The procedure was completed for 63 (79%) women in group 1, 73 (91%) in group 2, and 76 (95%) in group 3 (P=0.004). The proportion of completed procedures in group 3 was significantly different from that in group 1 (P=0.002), but did not differ significantly from that in group 2 (P=0.349). CONCLUSION: A uterine filling pressure of 60 mm Hg does not reduce the frequency of completion when compared with 80 mm Hg in operative outpatient hysteroscopy. CLINICALTRIALS. GOV REGISTRATION: NCT02142673.

Registry of implants for the reconstruction of pelvic floor in males and females: A feasibility case series.

INTRODUCTION: Most aspects of implant-assisted reconstruction of pelvic floor in males and females are under debate and the research is not standardized. Registries are supposed to shed light to the indications, surgical techniques and material properties and to establish a standardized evaluation. METHODS: A working group was formed to create an online platform for registration and outcome measurement of implant-assisted operations for pelvic organ prolapse (POP) and female and male stress urinary incontinence (SUI). 20 patients with modified mesh materials were evaluated over 23 months follow up in the registry to prove the feasibility of the registry. For validation a previously published modified "satisfaction, anatomy, continence, safety - S.(A.)C.S score" was used. RESULTS: A consensus was met on definitions and classifications of patient variables, surgical procedures and implants, as well as outcome parameters (efficacy, continence, satisfaction, complications). Different subgroup modules were formed in accordance with treated condition. The maximum score of cure was reached by 25-100% of patients depending on the indication. CONCLUSION: A prospective registry in accordance with IDEAL-D framework is justified for the evaluation and regulation of implants for pelvic floor reconstruction.

Postoperative Quality of Life and Sexual Function in Premenopausal Women Undergoing Laparoscopic Myomectomy for Symptomatic Fibroids: A Prospective Observational Cohort Study.

INTRODUCTION: Uterine leiomyomas are the most common benign gynecologic tumors. To date laparoscopy myomectomy is the gold standard for treatment of symptomatic fibroids in reproductive-aged women. Detailed counseling about the effects of this procedure on postoperative sexuality and quality of life is important in these patients. However, available data on these subjects are limited and contradictory. The aim of this study was to assess sexual function and quality of life in premenopausal women undergoing laparoscopic myomectomy for symptomatic uterine fibroids. MATERIAL AND METHODS: All premenopausal women who underwent laparoscopic myomectomy for symptomatic fibroids between April 2012 and August 2014 at a tertiary university center were enrolled in this prospective observational cohort study. Sexual function and quality of life were assessed for the pre- and postoperative (six months post-operatively) state using two validated questionnaires, the Female Sexual Function Index (FSFI) and the European Quality of Life Five-Dimension Scale (EQ-5D). RESULTS: Ninety-five of the 115 (83%) eligible patients completed the study. Overall a significant improvement in quality of life and sexual function was observed in the study cohort: Median FSFI (28 (18.7-35.2)) and EQ-5D scores (1 (0.61-1) after laparoscopic myomectomy were significantly higher than preoperative scores (21.2 (5.2-33.5); 0.9 (0.2-1); p ≤ 0.01). The number, position and localization of the largest fibroids were not correlated with pre- or postoperative sexual function or quality of life. CONCLUSION: Laparoscopic myomectomy might have positive short-term effects on postoperative quality of life and sexual function in premenopausal women suffering from symptomatic fibroids.

Risk Factors of Lymph Nodes Metastases by Endometrial Cancer: A Retrospective One-center Study.

BACKGROUND/AIM: We aimed to identify the surgical-pathological risk factors separately for pelvic and para-aortic lymph nodes (LN) metastases in endometrial cancer (EC). PATIENTS AND METHODS: The study cohort consisted of 179 patients with first diagnosis of EC, who were operated in our Institution between 2007 and 2014. RESULTS: Pelvic and para-aortic LN dissection was performed in 115 patients (64.2%). The positive pelvic and para-aortic LN were diagnosed in 11.3% and 16.1% of cases, respectively. Patients with bad differentiated tumors (G3) showed about 5-times more risk to have affected LN. Deep infiltration of myometrium elevated the risk of pelvic LN infiltration 5 times and of para-aortic LN infiltration 14 times. G3, myometrial infiltration >50% and type II endometrial cancer correlated with a worse progression free survival (PFS) and overall survival (OS). CONCLUSION: Tumor grade and deep myometrial invasion were the only significant predictors of pelvic and para-aortic lymph node metastases.

The significance of anterolateral neck cysts in early diagnosis of fetal malformations.

OBJECTIVE: The objective of this study is to examine the association of lateral fetal neck cysts with increased nuchal translucency, chromosomal abnormalities and fetal malformations. METHOD: In a consecutive collective of 4216 prenatal ultrasound examinations between 11 and 17 weeks of gestation 32 fetuses with lateral neck cysts were found. The size of the cysts was examined. The association of the findings with increased nuchal translucency, chromosomal aberrations and fetal malformations was examined. RESULTS: All but two out of 32 cases had bilateral cysts. Seventeen fetuses had aneuploidy and an increased nuchal translucency, 15 of those with major structural malformations. Of the 15 fetuses with normal karyotype nine (60%) had an increased nuchal translucency, seven had a fetal malformation or hydrops. A favorable outcome was found in 6/15 fetuses with normal karyotype and normal nuchal translucency. Lateral neck cyst diameter was associated to nuchal translucency, chromosomal abnormality and/or fetal malformations. Cysts smaller than 3 mm had a favorable outcome even in the presence of an increased nuchal translucency. CONCLUSION: Fetuses with lateral neck cysts often not only present with increased nuchal translucency and chromosomal aberrations but also with fetal malformations. Fetuses with lateral neck cysts and increased nuchal translucency were aneuploid or had a fetal malformation in 85%. Cysts smaller than 3 mm had a favorable outcome. © 2016 John Wiley & Sons, Ltd.

A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bilateral Sacropexy.

INTRODUCTION: Sacropexy is a generally applied treatment of prolapse, yet there are known possible complications of it. An essential need exists for better alloplastic materials. METHODS: Between April 2013 and June 2014, we performed a modified laparoscopic bilateral sacropexy (MLBS) in 10 patients using a MRI-visible PVDF mesh implant. Selected patients had prolapse POP-Q stages II-III and concomitant OAB. We studied surgery-related morbidity, anatomical and functional outcome, and mesh-visibility in MRI. Mean follow-up was 7.4 months. RESULTS: Concomitant colporrhaphy was conducted in 1/10 patients. Anatomical success was defined as POP-Q stage 0-I. Apical success rate was 100% and remained stable. A recurrent cystocele was seen in 1/10 patients during follow-up without need for intervention. Out of 6 (6/10) patients with preoperative SUI, 5/6 were healed and 1/6 persisted. De-novo SUI was seen in 1/10 patients. Complications requiring a relaparoscopy were seen in 2/10 patients. 8/10 patients with OAB were relieved postoperatively. The first in-human magnetic resonance visualization of a prolapse mesh implant was performed and showed good quality of visualization. CONCLUSION: MLBS is a feasible and safe procedure with favorable anatomical and functional outcome and good concomitant healing rates of SUI and OAB. Prospective data and larger samples are required.