The Feasibility of Practical Training in Minimally Invasive Surgery at Medical School-A Prospective Study on the Pelvitrainer.

Background and Objectives: The acquisition of practical skills at medical school is an important part of the multidimensional education program of future physicians. However, medical schools throughout the world have been slow in incorporating practical skills in their curriculum. Therefore, the aims of the present prospective study were (a) to demonstrate the feasibility of such surgical training, (b) to objectify its benefit in medical education, and (c) to investigate the impact of such training on subsequent career choices. Material and Methods: We introduced a two-day laparoscopy course on the pelvitrainer as part of the curriculum of the gynecological internship of fifth year medical students from 2019 to 2020. The results of the students' training were matched to those of surgeons who completed the same curriculum in a professional postgraduate laparoscopy course from 2017 to 2020 in a comparative study design. Additionally, we performed a questionnaire-based evaluation of the impact of the course on medical education and subsequent career choices directly before and after completing the course. Results: A total of 261 medical students and 206 physicians completed the training program. At baseline, the students performed significantly more poorly than physicians in a median of three of four exercises (p < 0.001). However, this evened out in the final runs, during which students performed more poorly than physicians only in one exercise and even better than physicians in one. The general integration of surgical training in medical school curricula was rated very low (12.4% on the VAS, IQR 3-16%) despite the high demand for such training. In the survey, the course was deemed very beneficial for medical education (median VAS 80.7%, IQR 73-98%), but did not appear to influence the students' subsequent career preferences. Conclusions: The acquisition of practical surgical skills during medical school is significantly under-represented in many medical faculties. The benefits of such training, as demonstrated in our study, would improve the education of future physicians.

Factors influencing surgical performance and learning progress in minimally invasive surgery - results of an interdisciplinary multicenter study.

BACKGROUND: Advancing surgical techniques require a high level of adaptation and learning skills on the part of surgeons. The authors need selection procedures and decision support systems for the recruitment of medical students and young surgeons. The authors aimed to investigate factors influencing the surgical performance and learning abilities of surgeons and medical students. MATERIALS AND METHODS: The training scores of persons attending 16 standardized training courses (at three training centers) of the German Working Group for Gynecological Endoscopy (AGE e.V.) from 2017 to 2020, individual characteristics, and the results of psychomotor tests of three-dimensional imagination and hand-eye coordination were correlated. Similar analyses were performed for medical students in their final clinical year from 2019 to 2020. The training concept was evaluated in a prospective, multicenter, interdisciplinary, multinational setting. RESULTS: In all, 180 of 206 physicians (response rate 87.4%) and 261 medical students (response rate 100%) completed the multistage training concept successfully. Of personal characteristics, the strongest correlation was noted for good surgical performance and learning success, and the absolute number of performed laparoscopic surgeries ( r =0.28-0.45, P <0.001/ r =0.1-0.28, P <0.05). A high score on the spatial visualization ability test was also correlated with good surgical performance ( r =0.18-0.27, P <0.01). Among medical students with no surgical experience, however, age was negatively correlated with surgical performance, that is the higher the age, the lower the surgical performance ( r =0.13/ r =0.22, P <0.05/ P <0.001). CONCLUSION: Individual factors (e.g. surgical experience, self-assessment, spatial visualization ability, eye-hand coordination, age) influence surgical performance and learning. Further research will be needed to create better decision support systems and selection procedures for prospective physicians. The possibilities of surgical training should be improved, promoted, and made accessible to a maximum number of surgical trainees because individual learning curves can be overcome even by less talented surgeons. Training options should be institutionalized for those attending medical school.

Assessment of the New Acceleromyograph TOF 3D Compared with the Established TOF Watch SX: Bland-Altman Analysis of the Precision and Limits of Agreement between Both Devices-A Randomized Clinical Comparison.

The new acceleromyograph TOF 3D was compared with the established TOF Watch SX in patients undergoing elective laparoscopic gynecological surgery. Neuromuscular transmission was assessed by simultaneous recording with both devices. Measurements were performed simultaneously at the left and the right M. adductor pollicis (Group A, 25 patients), or the M. corrugator supercilii (Group CS, 25 patients). The repeatability, time course, and limits of agreement (Bland-Altman) were compared. The primary endpoint was the 90% train-of-four recovery time (TOFR 0.9). Other endpoints included onset time of block, maximum T1 depression, time to 25% T1 recovery, the recovery time course of T1 response, and TOF ratio, respectively. In group CS, the repeatability coefficient of the TOF 3D was lower (4.66 (1.6)) than of the TOF Watch SX (6.02 (1.9); p = 0.026). In group A, the onset of the block was faster when measured by the TOF 3D (98.7 (30) s vs. 112.2 (36) s (mean (SD)); p = 0.032). In group A, time to recovery to a TOFR of 90% was measured earlier by the TOF 3D (bias -0.71 min, limits of agreement from -8.94 to +7.51 min). The TOF 3D provides adequate information with high precision and sensitivity. It is suitable even for measurement sites with small muscle contractions such as the M. corrugator supercilii.

The pelvitrainer for training in laparoscopic surgery - A prospective, multicenter, interdisciplinary study: Experimental research.

BACKGROUND: Minimally invasive surgical procedures have a flat learning curve, especially in the initial period of a surgeon's training. Pelvitrainers enable the prospective surgeon to drill the surgical technique, including camera navigation, instrument manipulation, and the individual steps of the operation, on a model rather than a patient. Integrating the pelvitrainer into standardized surgical training programs is challenging, but would be essential to achieve optimum effects of long duration in surgical education. MATERIAL AND METHODS: The pelvitrainer Realsimulator 2.0 (Endodevelop) was evaluated in 16 standardized training courses (at three training centers) of the German Working Group for Gynecological Endoscopy (AGE e.V.) from 2017 to 2020, The training concept was implemented and evaluated in a prospective, multicenter, interdisciplinary, multinational setting. RESULTS: One hundred and eighty of 206 physicians (response rate 87.4%) completed the multi-stage training concept successfully. A significant (p < 0.001) objective improvement (positive learning curve) was observed for all exercises on the pelvitrainer. The trainer's subjective evaluation revealed positive ratings for design (median 82%, IQR 71-91%), camera navigation (87%, IQR 76-95%), and instrument manipulation (median 87%, IQR 77-94%). A follow-up survey performed six months after the course confirmed its sustainable and high benefits in clinical routine (median 82%, IQR 70-97%). CONCLUSION: The present investigation proved the high educational value of pelvitrainers, which can be enhanced by using a structured training concept. The benefit of training courses for health care justifies their incorporation into a standardized training curriculum. The completion of such training courses should be regarded as a prerequisite for a doctor to qualify as an independent surgeon.

Laparoscopic versus vaginal native tissue repair in combination with pectopexy. Sub-analysis from an international, prospective, and multi-centre study: short term results.

INTRODUCTION: The use of mesh for vaginal repairs is currently problematic and as a consequence, there is increased interest in native tissue repair. We describe the follow-up data of a sub-analysis of a prospective and multi-center study focusing on the combination of pectopexy and native tissue repair. Patients were followed up for 12-18 months after surgery (+ SD: 15). Two-hundred and sixty-four patients attended the clinics for physical examination and were integrated into the follow-up. Cystocele repair was performed laparoscopically in 84 patients and vaginally in 52 patients. Posterior repair was performed vaginally in 40 patients and laparoscopically in 53 patients. RESULTS: Clinical success rate, patient recommendations and patient satisfaction rates were similar in both groups. The laparoscopic anterior repair resulted in an 89% cure or anatomical improvement rate; this compared to 94.2% for the vaginal approach. In the posterior group, laparoscopy resulted in a 94.3% cure or improvement rate compared to 97.5% in the second group. CONCLUSIONS: The outcomes of both strategies showed satisfactory results in our study. Consequently, surgeons may choose between the two strategies according to their preference and skill. The two approaches only differed with regard to vaginal scarring. We suggest future research investigating the long-term impact of scarring.

Preclinical safety testing and initial experience of a morcellation bag with four sealable ports.

Electromechanical morcellation-so called power morcellation-is a minimally invasive approach to remove bulky lesions such as uterine fibroids. The spread of benign and malignant tissue due to morcellation is a major concern that might limit the use of laparoscopic interventions. We present an in vitro evaluation of the safety characteristics of a four-port endobag with closable trocar sleeves, and describe physical properties of the bag that may or may not allow passage through the hole. In addition, we report our preliminary experience of this tool when used for laparoscopic supracervical hysterectomies. The behavior of the endobag during the extraction process was analyzed by extracting opened and re-sealed bags filled with 20 ml blue dye solution through a wooden template, with incisions measuring 10 to 24 mm. The endobag was used in 50 subtotal hysterectomies during the morcellation procedure. In the in vitro test, no dye loss was recorded for incisions measuring 11-24 mm. The mean force required to pull the bag through the template was inversely proportional to incision size. No bag rupture occurred during the surgical procedures. The mean time taken to prepare the bag for morcellation was 7.1 min (range, 4-14 min), the mean duration of subtotal hysterectomy was 53.4 min (range, 20-194 min). The mean weight of the removed body of the uterus was 113.8 g (range, 13-896 g), the mean weight of tissue and fluid remaining in the bag after morcellation 7.9 g (range, 0-39 g). In the in vitro setting, the improved endobag signifies greater patient safety during bag extraction, along with less tissue traumatization due to a smaller incision in the abdominal wall. The improved ergonomic features of the bag permit the insertion of three trocars in the lower abdomen and avoid closure of unused access ports. Our preliminary experience has shown that the device can be used under routine conditions. Failure rates will be evaluated in future studies.

Current Role of Hysterectomy in Pelvic Floor Surgery: Time for Reappraisal? A Review of Current Literature and Expert Discussion.

Since hysterectomy could be performed with low risk, it has been part of the standard of surgical prolapse therapy for decades. This has not been scrutinized for a long time. In this review, we describe the development of this issue in recent years. The current literature suggests that hysterectomy requires its own indication. The article describes the various options for a uterine-preserving surgical technique and the available data.

Is there a benefit for adjuvant radio(chemo)therapy in early cervical cancer? Results from a population-based study.

PURPOSE: Due to insufficient and conflicting prospective evidence, the recommendations on when to apply adjuvant radiochemotherapy in early-stage cervical cancer vary between international guidelines. In this population-based study, we evaluated the outcome of patients with early-stage cervical cancer based on risk factors and the adjuvant therapy they received. METHODS: The effect of primary therapy (surgery and radiochemotherapy RCT, surgery and radiotherapy RT, and surgery alone) on overall survival (OS) and recurrence-free survival (RFS) was evaluated in the complete cohort of 442 patients and in subgroups according to risk profile and nodal status. RESULTS: In low-risk patients, there was no difference in OS (p = 0.276) depending on whether patients received adjuvant therapy or not. Concerning RFS, patients with RT (including one patient with RCT) exhibited a significantly worse outcome compared to the group with surgery alone (p = 0.015). In intermediate-risk patients, the administration of adjuvant RT significantly benefited RFS when compared to surgery only in multivariate analysis (p = 0.031). Concerning OS, no significant influence for adjuvant treatment could be seen (p = 0.354). Though trends towards better OS and RFS could be observed in patients of the high-risk group-both in RCT and RT groups compared to surgery alone-the effects did not prove to be significant. CONCLUSION: Our study reaffirms the evidence against the use of adjuvant radio(chemo)therapy in low-risk early-stage cervical cancer. In intermediate-, and less pronounced in high-risk patients, however, it seems to be beneficial. The role of adjuvant radio(chemo)therapy in early cervical cancer should be further investigated in prospective randomized trials.

Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair.

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210-5.). The short-term follow-up of this international multicenter study carried out now is presented in this article. MATERIAL AND METHODS: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12-18 months. MAIN OUTCOME AND RESULTS: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. CONCLUSION: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy.

Laparoscopic approaches to the retropubic space: three alternatives with anatomical considerations.

INTRODUCTION: Many urogynecological and surgical laparoscopic interventions require access to the retropubic space, also known as the space of Retzius. Especially in patients with a history of previous surgery in this area or in general in the lower abdomen, the preparation may be complicated by adhesions and scar tissue. The necessity to combine several laparoscopic procedures in one surgical session may require consideration of the most appropriate way to approach the retropubic space. MATERIAL AND METHODS: We describe and discuss three different options to access the space of Retzius via laparoscopy: the medial transperitoneal, the extraperitoneal and the lateral transperitoneal approach. For all approaches, we used one umbilical trocar and two trocars in the lower abdomen. RESULTS: An algorithm was developed to select the most appropriate access route to the retropubic space, depending on the history of previous surgeries and accompanying interventions. CONCLUSION: The knowledge of different access routes to the retropubic space offers the possibility of adjusting the surgical procedure to the individual constellation of the patient.

Depth of Neuromuscular Block Is Not Associated with Abdominal Wall Distention or Surgical Conditions during Gynecologic Laparoscopic Operations. A Prospective Trial.

The influence of the degree of a neuromuscular block (NMB) on surgical operating conditions during laparoscopic surgery is debated controversially. The extent of abdominal distension during the time course of the NMB was assessed as a new measurement tool. In 60 patients scheduled for gynecologic laparoscopic surgery, the increase of the abdominal wall length induced by the capnoperitoneum was measured at 5 degrees of the NMB: intense NMB-post-tetanic count (PTC) = 0; deep NMB-train-of-four count (TOF) = 0 and PTC = 1-5; medium NMB-PTC > 5 and TOF = 0-1; shallow NMB-TOF > 1; full recovery-train-of-four ratio TOFR > 90%. Simultaneously, the quality of operating conditions was assessed with a standardized rating scale (SRS) reaching from 1 (extremely poor conditions) to 5 (excellent conditions). Fifty patients could be included in the analysis. The abdominal wall length increased by 10-13 mm induced by the capnoperitoneum. SRS was higher during intense NMB (4.7 ± 0.5) vs. full recovery (4.5 ± 0.5) (mean ± SD; p = 0.025). Generally, an intense NMB did not increase abdominal wall length induced by capnoperitoneum. Additionally, its influence on the quality of surgical operating conditions seems to be of minor clinical relevance.

Value of indocyanine green pelvic lymph node mapping in the surgical approach of cervical cancer.

PURPOSE: Lymph node metastasis is a significant predictive factor for disease recurrence and survival in cervical cancer patients and relevant for therapeutic strategies. We evaluated the clinical value of indocyanine green (ICG) by measuring the sensitivity and negative predictive value of sentinel lymph node mapping compared with the gold standard of complete lymphadenectomy in detecting lymph node metastases for cervical cancer. METHODS: We utilized the near-infrared imaging agent ICG to detect tumor-infested lymph nodes in the pelvis analogue to a classical sentinel lymph node procedure by analyzing data from 20 patients who had undergone surgery for cervical cancer at our institution. A laparoscopic lymph node mapping procedure by means of ICG, followed by a complete pelvic lymphadenectomy with or without paraaortic lymphadenectomy was done in all patients. RESULTS: Histological examination identified seven patients with tumor-positive pelvic nodes, whereas mapping with ICG identified only five of these patients. Detection rate of positive nodes by ICG mapping and false negative rate was 71.4% and 28.6%, respectively; bilateral detection rate was 83.3%. One of the two false negative patients additionally suffered from deep infiltrating endometriosis. CONCLUSIONS: Our results indicate that ICG can identify the relevant pelvic nodes independent of tumor size, provided bilateral detection is achieved and additional, related diseases are excluded. TRIAL REGISTRATION: This trial is registered within the German Clinical Trial Register (DRKS-ID: DRKS00014692).

Prospective international multicenter pectopexy trial: Interim results and findings post surgery.

The technique of laparoscopic pectopexy was published in 2010. A subsequent randomized trial focused on pectopexy versus sacropexy revealed no new risks for patients and significant advantages in terms of operating time and de novo defecation disorders compared to sacrocolpopexy. The present international multicenter trial was performed to evaluate the applicability of the technique in clinical routine. MATERIAL AND METHOD: Eleven clinics and 13 surgeons in four European counties participated in the trial. To ensure a standardized approach and obtain comparable data, all surgeons followed the same rules in placing the apical tape, no further mesh was used. Data were collected for 14 months on a secured server; 501 surgeries were documented and evaluated. RESULTS: Patients treated at the leading center (2 surgeons) contributed 44 % of the patient population. We made a distinction between high-volume (48-135 surgeries annually) (n = 4), intermediate-volume (28-37 surgeries annually) (n = 4), and low-volume (7-22 surgeries annually) (n = 5) surgeons. 97.3 % of the patients (n = 501) had delivered children; 5.6 % had had a Caesarian section. 29.7 % of the patients had undergone a hysterectomy. The operating time for pectopexy was less than 60 min in 79 % of cases. The procedures were completed in less than 159 min in 71 % of cases. Severe complications (n = 5) included four cases of organ damage (related to concomitant surgeries or adhesions) and one case of relevant bleeding. De novo incontinence was registered in two cases and voiding dysfunction in three. No intestinal obstruction or defecation disorder was observed. Two complicated infections were noted. Urinary infection occurred in 2 % of patients. CONCLUSION: In clinical routine severe complications occurred in 1 %. The latter were unrelated to pectopexy, but occurred due to concomitant procedures or adhesions. The overall operating time as well as the operating time for pectopexy were similar to those reported in published studies on sacrocolpopexy.

Impact of nodal status and treatment strategy on overall survival in advanced stage cervical cancer.

PURPOSE: The lack of prognostic data impedes implementation of optimal therapy for cervical cancer. For instance, recommended therapy for FIGO IIB cervical cancer is radical hysterectomy or radiochemotherapy. To enlighten different therapeutic approaches, we investigated the benefit of individual therapies or combination thereof in patients with or without infested lymph nodes. METHODS: The German Tumor Centre Regensburg registered 389 patients with FIGO IIB, IIIA, IIIB, and IVA cervical cancer between 2002 and 2015. We estimated hazard ratios (HR) for overall survival against different therapies using univariable and multivariable cox regression. After risk adjustment with respect to clinicopathological parameters, we performed model selection using conditional stepwise reverse selection. RESULTS: We demonstrated the need for thorough assessment of the nodal status to obtain reliable data for treatment strategy. Our analysis showed significant differences for overall survival in FIGO IIB depending on therapy and nodal status. Outcome was inferior with radiochemotherapy without surgery for patients with N0 compared to surgery and radiochemotherapy combined (HR 3.012; 95% CI 1.075-8.441; p = 0.036); however, for N1, radiochemotherapy without surgery resulted in comparable outcome (HR 0.808; 95% CI 0.189-3.403; p = 0.765), whereas surgery alone yielded in poor outcome (HR 2.889; 95% CI 1.356-6.156; p = 0.006). Regardless of the nodal status, chemotherapy was superior in advanced stage cervical cancer FIGO III to IVA. CONCLUSIONS: Our study suggests that in terms of oncological outcome FIGO IIB cervical cancer patients benefit from a combination of surgery and radiochemotherapy. However, in the presence of lymph node infestation, surgery does not add substantial benefit to the patient.

Laparoscopic anterior and posterior native tissue repair: a new pelvic floor approach.

Introduction: Traditionally, a cystocele caused by a midline defect of the pelvic fascia is treated by vaginal fascia duplication, also known as anterior colporraphy. The rectocele is managed by suturing the posterior fascia and, frequently, the levator ani muscles. We developed the approach of laparoscopic anterior and posterior fascia repair by native tissue. Material and methods: The methods were based on anterior and posterior exposure of pelvic fascia similar to the preparation of an extended sacral colpopexy. The fascia was compressed and narrowed by absorbable woven sutures, size 1. Twenty-seven patients were followed up for 6-13 months. All patients received additional apical fixation by pectopexy. Results: In the examination group, 13 patients underwent anterior laparoscopic fascia repair and 23 had posterior repair. We detected one apical and one posterior relapse, and also one in the anterior repair group. The patient with the apical relapse reported pain and de novo urgency. Anatomical reconstruction was achieved in all other patients. Summary: Laparoscopic anterior and posterior native tissue repair appears to be a feasible method for the treatment of midline cystocele and rectocele. No new risks were observed. The technique leaves no scar in the vagina and is well accepted. Abbreviations: POPQ: Pelvic Organ Prolapse Quantification System; FDA: Food and Drug Association; US: United States; Fig: Figure; ICIQ: International Consultation on Incontinence Questionnaire.

[Comparison of International Guidelines For the Application of Cardiotocography]. / Vergleich internationaler Leitlinien zur Anwendung der Cardiotokografie.

OBJECTIVE: This study examines the recommendations of international guidelines on the use of antepartum and intrapartum cardiotocography. MATERIAL AND METHODS: The guidelines of Germany, Canada, UK, USA, Sri Lanka, Australia as well as FIGO have been compared. The recommendations on the use of cardiotocography were separately evaluated for antepartum and intrapartum use. RESULTS: Antepartum: In risk-free pregnancies the use of cardiotocography is not recommended in all countries. On the other hand the use of cardiotocography is indicated in the presence of a defined maternal and fetal risk factors. While the NICE guidelines recommend cardiotocography in the case of maternal hypertension, as well as preeclampsia, the German guidelines as well as SOGC list considerably more risk factors. Intrapartually, the recommendations vary greatly from country to country. While German guidelines suggest the use of cardiotocography from late 1st stage of labor, the other countries strongly recommend the auscultation of the fetal heart rate of non-risk pregnancies. This is due to the current study situation, which does not show any advantage of cardiotocography as opposed to intermittent auscultation. Furthermore studies have indicated that the use of cardiotocography caused an increase in iatrogenic induced cesarean sections. In high risk pregnancies the use of cardiotocography is strongly recommended in the compared countries, however there are major differences in the definition of high risk pregnancy and therefore the indication for cardiotocographic monitoring. CONCLUSION: Intermittent auscultation is a more cost-effective alternative compared to cardiotocography. However, in the case of legal litigation intermittent auscultation is harder to reconstruct the well-being of the newborn during birth. On the other hand cardiotocography might result in a higher cesarean section rate, but can be more helpful to prove fetal well-being during birth for a legal litigation process. Despite the lack of evidence only German guidelines recommend cardiotocographic monitoring from the late 1st stage of labor for risk-free pregnancies.

Comparison of the trapezius and the adductor pollicis muscle as predictor of good intubating conditions: a randomized controlled trial.

BACKGROUND: Adequate muscle relaxation is important for ensuring optimal conditions for intubation. Although acceleromyography of the adductor pollicis muscle is commonly used to assess conditions for intubation, we hypothesized that acceleromyography of the trapezius is more indicative of optimal intubating conditions. The primary outcome was the difference between both measurement sites with regard to prediction of good or acceptable intubating conditions. METHODS: Neuromuscular blockade after injection of rocuronium 0.3 mg/kg IV was measured simultaneously with acceleromyography of the adductor pollicis muscle and the trapezius muscle in sixty female patients, American Society of Anesthesiologists physical status I to III, undergoing general anesthesia for gynecologic surgery. Exclusion criteria were: expected difficult tracheal intubation (e.g. history of difficult intubation, reduced mouth opening (< 2 cm) and/or Mallampati Score 4), increased risk of pulmonary aspiration (e.g. gastroesophageal reflux or delayed gastric emptying) allergies to drugs used during the study, pregnancy, neuromuscular diseases, medication with potential to influence neuromuscular function (e.g. furosemide, magnesium, cephalosporins) and hepatic or renal insufficiency (serum bilirubin >26 µmol/L, serum creatinine >90 µmol/l). Patients were randomized to 2 groups: group A (n = 30): endotracheal intubation after onset of the neuromuscular block at the adductor pollicis muscle. Group B (n = 30): endotracheal intubation after onset at the trapezius muscle. Intubating conditions were compared between both groups by means of a standardised score (the Copenhagen score) with Fisher's exact test. RESULTS: Onset of the block after rocuronium injection was observed at the adductor pollicis muscle compared to the trapezius with 2.8 (1.1) versus 2.5 (1.1) min (mean ± SD; P = 0.006). Intubating conditions were poor in 2 patients (7%) of group A, and in 1 patient (3%) of group T. They were acceptable (either excellent or good) in 28 patients (93%) in group A, and in 1 patient (97%) in group T (P = 0.82). CONCLUSIONS: Performing acceleromyography at the trapezius muscle reduced the time between injection of neuromuscular blocking agents and intubation by 18 s (11%). Thus, trapezius muscle acceleromyography is an acceptable alternative to adductor pollicis muscle acceleromyography in predicting acceptable intubating conditions, which allows for earlier indication of adequate intubating conditions. TRIAL REGISTRATION: ClinicalTrial.gov Identifier: NCT01849198 . Registered April 29, 2013.

Preclinical safety testing for morcellation and extraction for an endobag with sealable ports: in vitro pilot study.

BACKGROUND: Electromechanical power morcellation is an important tool of modern laparoscopy. Recent reports on the spread of previously undetected malignancy by power morcellation indicate the need for additional protective devices to reduce this risk. We conducted a study to obtain the first data concerning the safety of an endobag with three closable ports during morcellation and subsequent bag extraction under in vitro conditions, mimicking the settings in our operating theater. The second purpose of the study was to establish a minimal width of the skin incision necessary to safely extract the sealed bag after morcellation. METHODS: The morcellation test was carried out on 11 stained porcine muscle tissue samples with one additional sample as a control. The insufflation pressure was set at 12 mmHg. After filling the endobag with blue dye solution, an additional extraction test was conducted by pulling the closed bag through a template with apertures of various diameters. For each opening, a series of ten bag extractions was carried out. RESULTS: No loss of solid material or fluid was recorded during the morcellation test. The extraction test showed a loss of fluid for template openings smaller than 18 mm. The force necessary to extract the bag was inversely related to the width of the aperture. CONCLUSIONS: The data suggest that under the evaluated conditions, the use of a closable morcellation bag can considerably improve the patient's safety during morcellation. Further studies are necessary to evaluate the influence of the bag on operating time, intervention costs and complications.

Safety and economical innovations regarding surgical treatment of fibroids.

Uterine leiomyomas are the most frequent benign tumors of the female genital tract. Fibroids are associated with a variety of clinical problems, e.g. bleeding disorders, bulk-related symptoms or infertility. For women wishing to preserve their uterus, fibroids can be surgically removed by hysteroscopy, laparoscopy or laparotomy. The purpose of our review is to show that hysterectomy offers the only definitive solution. The indication for treatment has to be taken carefully after weighing up alternative treatment methods, such as expectant management, medical treatment or interventional radiologic methods, and after obtaining informed consent. The optimal method of treatment takes into account the patient's interests and wishes and the practical feasibility in the clinical setup. Surgical skills and experience play an important role as surgical procedures on the uterus are not without risk and can lead to severe complications. The decision to operate anticipates an improvement of the initial situation; therefore, the ideal surgical approach is of utmost importance.