Hybrid argon plasma coagulation (HybridAPC) versus sharp excision for the treatment of endometriosis: a prospective randomized clinical trial.

PURPOSE: Endometriosis is a benign, but potentially serious gynaecological condition in terms of abdominal pain and impaired fertility. Laparoscopic excision techniques are considered the therapeutic standard. HybridAPC is presented as a novel technique for the non-contact thermal ablation of peritoneal endometriosis with simultaneous protection of the underlying thermosensitive structures by creating a needle-free elevated fluid cushion which enables a safer exposure and distance, as well as potentially improved peritoneal conditioning prior to APC. METHODS: In this prospective randomized clinical trial, 39 patients with 132 superficial endometriotic lesions in total were treated with HybridAPC or sharp excision in an initial laparoscopic procedure according to randomization. In a second-look laparoscopy, adhesion formation was rated macroscopically. Histologic samples were taken from previously treated areas for evaluation of eradication rate. RESULTS: The eradication rate was not significantly different between HybridAPC treatment and sharp excision (65 vs. 81%, p = .55). Adhesions formed in 5% of HybridAPC-treated lesions and in 10% after sharp excision (p = .49). HybridAPC treatment was significantly faster than sharp excision (69 vs. 106 s, p < .05). No intra- and postoperative complications were registered. CONCLUSION: This clinical trial demonstrates the feasibility of this novel surgical technique with a promising impact on adhesion prevention. Compared to sharp excision, HybridAPC is likely to be a safe, tissue-preserving, and fast method for the treatment of peritoneal endometriosis.

An ergonomic field study to evaluate the effects of a rotatable handle piece on muscular stress and fatigue as well as subjective ratings of usability, wrist posture and precision during laparoscopic surgery: an explorative pilot study.

PURPOSE: The interface between surgeon and the laparoscopic instrument is an important factor in biomechanical stress that may increase the risk of musculoskeletal complaints in surgeons. This article investigates the effect of a laparoscopic instrument with a rotatable handle piece (rot-HP) on muscular stress and fatigue during routine laparoscopic procedures (LP) as well as usability, wrist posture and working precision. METHODS: 40 LP (subtotal hysterectomies) performed by 11 surgeons were investigated. 20 LP were carried out with the rot-HP and 20 with a fixed (standard) laparoscopic handle piece instrument. Shoulder and arm muscle activity was monitored via surface electromyography (sEMG). The electrical activity (EA) and median power frequency (MPF) were used to determine muscular stress and fatigue. Usability, wrist posture, and working precision between handle piece conditions were assessed by a survey. RESULTS: Using the rot-HP did not reduce muscular stress. A tendency of muscular fatigue (increasing EA, decreasing MPF) occurred in the upper trapezius, middle deltoid and extensor digitorum muscles; however, no differences were found between handle pieces. Wrist posture was more comfortable using the rot-HP and working precision and usability tended to be preferred using the standard handle piece. CONCLUSIONS: Although wrist posture seemed to be optimized by the rot-HP, no effect on muscular stress and fatigue was observed in routine LP (< 60 min duration). Optimization of wrist posture may provide positive effects in mid- or long-term procedures. However, sufficient familiarization with the new instrument is crucial since working precision and usability could be impaired.

A prospective randomized experimental study to investigate the peritoneal adhesion formation after waterjet injection and argon plasma coagulation (HybridAPC) in a rat model.

BACKGROUND: This prospective, randomized, controlled, single-blinded study investigates the peritoneal adhesion formation of HybridAPC (waterjet elevation of the peritoneum with subsequent argon plasma coagulation) versus only waterjet (elevation with the same instrument, but without subsequent argon plasma coagulation) in a rat model (24 female Wistar rats). MATERIALS AND METHODS: Bilateral lesions were created on the abdominal wall with HybridAPC on one sidewall and waterjet elevation on the other sidewall of the peritoneum in a standard fashion. After 10 days, the rats were euthanized to evaluate the peritoneal trauma sites. MAIN OUTCOME MEASURE(S): Adhesion incidence, quantity, and quality were scored 10 days postoperatively and studied histopathologically. RESULT(S): Incidence of adhesion formation was 2.3% for HybridAPC; no adhesions occurred for peritoneal elevation with saline (p = 1.00). Histologic evaluation revealed no acute inflammation in both groups. An overall moderate degree of granulation tissue formation and myonecrosis was observed in the HybridAPC group, whereas no chronic inflammation and myonecrosis occurred after elevation without thermal ablation (p < 0.0001). CONCLUSION(S): This study investigates the effect of waterjet elevation of the peritoneum with and without subsequent thermal ablation on adhesion formation in a rat model for the first time. Peritoneal waterjet elevation with saline does not provide any risk of adhesion formation. Thermal coagulation with APC after waterjet elevation of the peritoneum creates advantageous peritoneal conditions due to a permanent moist tissue surface and the cooling effect of the injected solution, resulting in no significant difference in adhesion formation compared to peritoneal elevation without thermal ablation. HybridAPC can thus be regarded as a beneficial coagulation method with only minor adhesion formation due to positive tissue effects of the combined waterjet.

Ergonomic Benefits From a Laparoscopic Instrument With Rotatable Handle Piece Depend on the Area of the Operating Field and Working Height.

Objective To evaluate the effect of a laparoscopic instrument with a 360° rotatable handle piece (rot-HP) on biomechanical stress and precision in different areas of a simulated operating field at two working heights. Background Surgeons performing laparoscopic procedures are exposed to biomechanical stress and have an increased risk of musculoskeletal complaints. Method Fifty-seven healthy subjects (27 men, median age 26) without experience in laparoscopy performed a precision task in four quadrants (A-D) of the operating field using the rot-HP or a common fixed handle piece (fixed-HP) at an individually adjusted lower or higher working height. Biomechanical stress was assessed by surface EMG, wrist joint angles, and arm postures and precision by the number of mistakes. Results Using the rot-HP reduced muscle activity of the biceps brachii and flexor carpi radialis muscle. An interaction of flexor activity and area of the operating field occurred with the lowest activity in Quadrant C. Wrist joint angles were more neutral using the rot-HP, especially when the lower working height was applied and in Quadrants B and C. However, increased wrist dorsal flexion occurred in Quadrant A while using the rot-HP. Arm postures and precision were less affected. Conclusion The rot-HP allows some reductions of stresses in the arm and hand region, whereas the stress in the shoulder neck region is not modified. Application The instrument's position and the working height may have to be considered as mediatory factors when describing the effectiveness of an ergonomic handle design for laparoscopic instruments.

In silico evaluation of geometry variations with respect to the thermal spread during coagulation of egg white using bipolar vessel sealing instruments.

BACKGROUND: Bipolar vessel sealing is an efficient electrosurgical procedure for the occlusion of blood vessels particularly during minimally invasive surgery. Reliable knowledge of the thermal spread is crucial for a safe application of bipolar vessel sealing instruments when operating close to thermo-sensitive structures, such as nerves. The evolution of the thermal spread over time and space depends on a variety of parameters, such as the biological tissue, the energy applied to the tissue, and the geometry of the vessel sealing instrument. Mathematical modeling has proven useful for the prediction of the thermal spread. It is, thus, a promising tool for the systematic analysis of the influence of geometrical changes on the thermal spread. RESULTS: We present an experimentally validated in silico study to evaluate the impact of geometry variations on the progression of chicken egg white coagulation and the final shape of coagulated egg white as an approximation of the temporal and spatial evolution of the thermal spread during bipolar vessel sealing. Egg white has similar thermal and electrical properties to human tissue, with the advantage being that the spatial and temporal evolution of the thermal spread can be visually gauged. The simulations were performed using a mathematical model based on the finite element analysis of chicken egg white. The progression of egg white coagulation was predicted for two different peak voltages and various electrode geometries. Starting with two planar electrodes, one electrode was gradually changed to adopt a wedge shape. These changes to the geometry showed a distinct influence on the progression of egg white coagulation in the simulations. The predictions were successfully validated using an experimental setup with two different electrodes representing the extreme geometries. DISCUSSION: The predicted spatial temperature distributions were experimentally validated for two geometries. Our simulation study shows that the geometry has a pronounced influence on the thermal spread and, thus, is a suitable parameter to reduce thermal damage. The in silico optimization of instrument designs is a suitable tool to accelerate the development of new vessel sealing instruments, with only a few promising designs having to be tested as prototypes.

Effect of a laparoscopic instrument with rotatable handle piece on biomechanical stress during laparoscopic procedures.

OBJECTIVE: To investigate the effect of a pistol grip laparoscopic instrument with a rotatable handle piece (rot-HP) on biomechanical stress and precision as well as a possible interaction between the instrument and working height (WH). BACKGROUND: Biomechanical stress induced by laparoscopic surgery (LS) is associated with work-related upper limb musculoskeletal disorders in surgeons. Ergonomic handle designs of laparoscopic instruments may reduce the risk of musculoskeletal disorders. METHODS: Without LS experience, 57 healthy subjects (30 women; 27 men, median age: 26) were observed while performing a laparoscopic exercise. Subjects had to pick up coloured pins and place them into a colour-coded wooden set-up inside a pelvitrainer. The exercise was performed at two WHs using the rot-HP and a standard laparoscopic (fixed) handle piece in randomized sequence. Biomechanical stress was monitored via surface electromyography (sEMG) on fife muscles from the upper limb and shoulder region. Further, the wrist angle (palmar and dorsi flexion) and posture of the dominant upper arm were recorded. Precision was assessed using the number of validly placed pins and process time. RESULTS: sEMG parameters and upper arm postures indicated no differences in biomechanical stress related to either laparoscopic handle piece. The higher WH was associated with higher trapezius and deltoid activity and elevated arm postures (p < 0.05). Neutral wrist positions were more frequent using the rot-HP, and the lower WH resulted in slightly more neutral wrist positions. Precision was similar during all experimental conditions. CONCLUSIONS: The rot-HP did not decrease biomechanical stress in the shoulder or lower arm muscles. However, wrist angle position may be optimized without affecting precision. Long-term effects of the rot-HP on preventing complaints of the upper extremity should be evaluated. Low WH is recommended to reduce biomechanical stress in the shoulder during laparoscopic surgery.

A Prospective Randomized Experimental Study to Investigate the Eradication Rate of Endometriosis after Surgical Resection versus Aerosol Plasma Coagulation in a Rat Model.

PURPOSE: To investigate the eradication rate of endometriosis after surgical resection (SR) vs. thermal ablation with aerosol plasma coagulation (AePC) in a rat model. METHODS: In this prospective, randomized, controlled, single-blinded animal study endometriosis was induced on the abdominal wall of 34 female Wistar rats. After 14 days endometriosis was either removed by SR or ablated by AePC. 14 days later the rats were euthanized to evaluate the eradication rate histopathologically. Intervention times were recorded. RESULTS: Eradication rate of endometriosis after 14 days did not significantly differ between AePC and SR (p=0.22). Intervention time per endometrial lesion was 22.1 s for AePC and 51.8 s for SR (p<0.0001). CONCLUSIONS: This study compares the eradication rate of the new aerosol plasma coagulation device versus standard surgical resection of endometriosis in a rat model. Despite being a thermal method, AePC showed equality towards SR regarding eradication rate but with significantly shorter intervention time.

Development of an arm support system to improve ergonomics in laparoscopic surgery: study design and provisional results.

BACKGROUND: Laparoscopic surgery (LS) induces physical stress to the surgeon that is associated with an increased prevalence of musculoskeletal pain and injury in the shoulder-neck region. The aim of this research project is to develop an arm support system (ASsyst) that reduces physical stress and is applicable to various laparoscopic interventions and operation room settings. METHODS: A systematic approach to develop an ASsyst started in October 2012 consisting of five consecutive steps. In step 1, 14 laparoscopic interventions were observed using subjective and objective measures to determine key indicators for the conception of an ASsyst in LS. In step 2, an expert workshop was held to find and evaluate solutions to generate concepts for a support system based on the results of step 1 and general methods. During the third step, prototypes of ASsyst were tested in an experimental setting. Steps 4 and 5 are currently in process and include the final development of the ASsyst using the most promising concept for the evaluation during simulated LS. RESULTS: Increased levels of physical stress were found in LS. Asymmetric strains were common. Three prototypes of ASsyst emerged from step 1 and 2. These prototypes were a cable construction with a noose for the lower arm, a support from below the elbow and a pneumatic vest supporting the upper arm. The experimental testing of these prototypes demonstrated reduced physical stress when compared to the unsupported environment. The support from below the elbow seemed to be the most practical in terms of implementation in various operation room settings and acceptance by surgeons. Step 4 and 5 are still in process. CONCLUSIONS: Ergonomic problems have been identified in LS that could be addressed by an ASsyst. The concept of supporting the elbow from below has been found to be the most promising approach.

Prevalence and prognostic value of disseminated tumor cells in primary endometrial, cervical and vulvar cancer patients.

AIMS: Disseminated tumor cell (DTC) detection in bone marrow (BM) of primary breast cancer patients predicts poor prognosis. This study investigates the prevalence of DTCs and their prognostic significance in primary gynecologic malignancies. PATIENTS & METHODS: DTCs from BM aspirates of 603 patients with endometrial (311), cervical (228) and vulvar cancer (64) were identified by the pancytokeratin antibody A45B/B3. RESULTS: DTCs were detected in 18% of BM aspirates (21, 16 and 16% in endometrial, cervical and vulvar cancer, respectively). In cervical cancer, DTCs were associated with International Federation of Gynecology and Obstetrics stage, nodal status and lymphangiosis. There was no association between BM status and prognosis. CONCLUSION: Tumor cell dissemination is common in gynecological cancer. In contrast to breast cancer, DTCs that derive from cervical, endometrial or vulvar cancer have less potential to initiate metastatic regrow. The molecular mechanisms underlying this observation warrant further investigation.

A Prospective Experimental Study to Investigate the Peritoneal Adhesion Formation of Argon Plasma Coagulation (APC) Versus a Novel Aerosol Plasma in a Rat Model.

BACKGROUND: This is a prospective, randomized, controlled, single-blinded study to investigate peritoneal adhesion formation of standard argon plasma coagulation (APC) versus aerosol plasma coagulation in a rat model. METHODS: Bilateral lesions were created on the abdominal wall of 16 female Wistar rats with standard and aerosol plasma coagulation APC energy in a standard fashion. After 10 days, the rats were killed humanely to evaluate the peritoneal trauma sites. Adhesion incidence, quantity, and quality were scored 10 days postoperatively and studied histopathologically. RESULTS: Average energy intake was 97.7 ± 3.1 J for APC and 93.8 ± 4.2 J for aerosol plasma coagulation. Incidence of adhesion formation was 74.2% for standard APC and 16.1% for aerosol plasma coagulation (P < .0001). Standard APC mainly results in dense adhesions. Histological evaluation revealed no significant difference with regard to the average depth of lesions created by APC and aerosol plasma coagulation (P = 0.21) at day 10; both groups showed an identical morphology of necrosis and granulation tissue formation. CONCLUSIONS: This study compares adhesion formation of standard APC versus aerosol plasma coagulation in a rat model. Standard APC produced significantly more adhesions. Aerosol plasma coagulation creates fewer adhesions, which are of lower grade, which seems to be achieved mainly by improved peritoneal conditioning in this animal model.

Multicenter evaluation of blood-based biomarkers for the detection of endometriosis and adenomyosis: A prospective non-interventional study.

OBJECTIVE: To evaluate blood-based biomarkers to detect endometriosis and/or adenomyosis across nine European centers (June 2014-April 2018). METHODS: This prospective, non-interventional study assessed the diagnostic accuracy of 54 blood-based biomarker immunoassays in samples from 919 women (aged 18-45 years) with suspicion of endometriosis and/or adenomyosis versus symptomatic controls. Endometriosis was stratified by revised American Society for Reproductive Medicine stage. Symptomatic controls were "pathologic symptomatic controls" or "pathology-free symptomatic controls". The main outcome measure was receiver operating characteristic-area under the curve (ROC-AUC) and Wilcoxon P values corrected for multiple testing (q values). RESULTS: CA-125 performed best in "all endometriosis cases" versus "all symptomatic controls" (AUC 0.645, 95% confidence interval [CI] 0.600-0.690, q < 0.001) and increased (P < 0.001) with disease stage. In "all endometriosis cases" versus "pathology-free symptomatic controls", S100-A12 performed best (AUC 0.692, 95% CI 0.614-0.769, q = 0.001) followed by CA-125 (AUC 0.649, 95% CI 0.569-0.729, q = 0.021). In "adenomyosis only cases" versus "symptomatic controls" or "pathology-free symptomatic controls", respectively, the top-performing biomarkers were sFRP-4 (AUC 0.615, 95% CI 0.551-0.678, q = 0.045) and S100-A12 (AUC 0.701, 95% CI 0.611-0.792, q = 0.004). CONCLUSION: This study concluded that no biomarkers tested could diagnose or rule out endometriosis/adenomyosis with high certainty.

A prospective, randomized clinical comparison between UltraCision and the novel sealing and cutting device BiCision in patients with laparoscopic supracervical hysterectomy.

BACKGROUND: Various surgical procedures for hysterectomy exist; with laparoscopic supracervical hysterectomy (LASH) becoming an established option in recent years. Therefore, energy-based technologies for rapid tissue sealing and cutting are in the focus of surgeons. The aim of this trial was to prove or disprove investigated noninferiority of the novel device BiCision in comparison to the widely used UltraCision in a routine procedure ( www.clinicaltrials.gov ; study identifier NCT01806012). METHODS: Thirty LASH procedures were performed with UltraCision and BiCision after randomization of the preparation sides. The primary end point was the resection time per side and instrument. The instruments were also compared concerning blood loss and coagulation and cutting qualities as well as postoperative complications. The patients were followed for 3 months. RESULTS: Mean preparation time per side was 8.8 ± 1.8 min for BiCision and 8.3 ± 1.9 min for UltraCision (p = 0.31), which was not significantly different. Both instruments achieved complete transection without the need of additional cutting attempts. BiCision was significantly superior regarding the number of coagulations for complete hemostasis before and after the removal of the uterine corpus (before: 6.9 ± 4.8 for BiCision and 8.6 ± 4.1 for UltraCision, p = 0.047; after: 5.4 ± 1.2 for BiCision and 8.6 ± 3.2 for UltraCision, p < 0.0001) and intraoperative blood loss (score 1.07 ± 0.25 for BiCision vs. 1.63 ± 0.49 for UltraCision, p < 0.0001). Tissue sticking to the instrument occurred less often on the BiCision side (score 0.14 ± 0.35 for BiCision vs. 0.60 ± 0.81 for UltraCision, p = 0.015). BiCision showed a significantly better fixation of the tissue (grip score 0.23 ± 0.43 for BiCision vs. 1.00 ± 0.74 for UltraCision, p < 0.0001). No intraoperative or postoperative complications were seen for both instruments. CONCLUSIONS: The efficacy and quality of vessel sealing and cutting with BiCision is not inferior to the UltraCision device. Resection time was comparable, and complete hemostasis could be achieved faster in a clinical setting. Therefore, BiCision is at least as reliable as UltraCision for laparoscopic indications.

Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial.

OBJECTIVE: To compare the EnSeal device with standard bipolar coagulation forceps in laparoscopic supracervical hysterectomy (LASH). DESIGN: Prospective, randomized, controlled trial (Canadian Task Force classification I). SETTING: University hospital. PATIENTS: One hundred sixty patients who underwent LASH. INTERVENTION: Eighty patients underwent LASH using the EnSeal device (experimental group), and 80 patients underwent LASH using standard bipolar coagulation forceps (control group) (www.clinicaltrials.gov; study identifier NCT01806012). MEASUREMENTS AND MAIN RESULTS: Mean (SD) total operative time was 78.18 (33.96) minutes in the experimental group and 86.30 (35.34) minutes in the control group (p = .03). Documented blood loss was <50 mL in 72 patients in the experimental group and 62 patients in the control group (p = .03), and was 50 to 100 mL in 8 patients in the experimental group and 18 patients in the control group (p < .001). Postoperative hospital stay was significantly shorter for patients in the experimental group compared with the control group: 2.01 (0.44) days vs 2.17 (0.47) days, respectively (p = .03). There was no difference in postoperative pain scores and complications between the two treatment groups. CONCLUSION: Total resection time was shorter in the experimental group, and the other investigated clinical parameters were not inferior in the experimental group compared with the control group. The results of the present study indicate that use of the EnSeal device is at least as reliable as the conventional electrocoagulation technique in LASH.

Laparoscopic supracervical hysterectomy (LSH) versus total laparoscopic hysterectomy (TLH): an implementation study in 1,952 patients with an analysis of risk factors for conversion to laparotomy and complications, and of procedure-specific re-operations.

PURPOSE: To compare laparoscopic supracervical hysterectomy (LSH) with total laparoscopic hysterectomy (TLH) with regard to relevant surgical parameters and risk factors of conversion to laparotomy and complications. METHODS: This prospective, open, single-center, interventional study included women with benign gynecologic disease who underwent standardized LSH or TLH. The techniques were compared for conversion rate and mean operating time, hemoglobin drop, hospital stay, and complication rates using descriptive statistics and standard non-parametric statistical tests. Risk factors of conversion and complications were identified by logistic regression analysis. RESULTS: During January 2003 to December 2010, 1,952 women [mean age (SD): 47.5 (7.2) years] underwent LSH [1,658 (84.9%)] or TLH [294 (15.1%)], mostly (>70%) for uterine fibroids. Significant differences in surgical parameters were observed for conversion rate (LSH/TLH: 2.6/6.5%), mean operating time [87 (34)/103 (36) min], hemoglobin drop [1.3 (0.8)/1.6 (1.0) g/dL], and hospital stay [4.3 (1.5)/4.9 (2.8) days]. Overall intraoperative (0.2/0.7%) and long-term (>6 weeks) post-operative (0.8/1.7%) complication rates did not differ significantly, but the short-term LSH complication rate was significantly lower (0.6 vs. 4.8%). Spotting (LSH, 0.2%) and vaginal cuff dehiscence (TLH, 0.7%) were long-term method-specific complications. Logistic regression showed that uterine weight and extensive adhesiolysis were significant factors for conversion while previous surgery, age, and BMI were not. Major risk factors of short-term complications were age, procedure (LSH/TLH), and extensive adhesions. CONCLUSIONS: Both procedures proved effective and were well tolerated. LSH performed better than TLH regarding most outcome measures. LSH is associated with very low rates of re-operation and spotting.

The influence of removal of primary tumor on incidence and phenotype of circulating tumor cells in primary breast cancer.

Recent studies have shown that the detection of circulating tumor cells (CTC) pre and postoperatively in the peripheral blood of primary breast cancer patients may be an indicator for poor survival. This study aimed to investigate the influence of removal of the primary tumor on incidence and phenotype of circulating tumor cells in primary breast cancer. 209 primary breast cancer patients could be included into this analysis. Blood sampling was performed both pre and postoperatively. The blood specimens were immunomagnetically enriched using AdnaTest BreastCancerSelect within 4 h after blood withdrawal, followed by RNA isolation and subsequent gene expression analysis by reverse transcription and multiplex PCR using AdnaTest BreastCancerDetect. Three breast cancer-associated tumor markers and two hormone receptor genes were amplified: GA733-2, Muc-1, Her-2, ER, PR. In addition, bone marrow (BM) status was intraoperatively determined. Forty-three of 209 patients (21%) had pre and/or postoperatively circulating tumor cells. The positivity rates after surgery were higher but did not differ significantly (12% pre and 16% postoperatively, P = 0.264). Disseminated tumor cells in BM were seen in 32 of 209 cases (15%). Patients with positive BM status had significantly higher CTC positivity rates both pre and postoperatively compared to those with negative BM status. The most common CTC phenotype was triple negative (24 patients) followed by HER2+/ER-/PR- subtype (10) and ER and/or PR positive (9). Interestingly, 41 of 43 primary tumors (95%) were ER and PR positive. Removal of the primary tumor did not alter the phenotype of CTC. Surgery does not significantly influence the tumor cell load in the blood stream. CTC phenotype before and after the surgery generally remains identical but may differ from that of the primary tumor.

Hematogenous and lymphatic tumor cell dissemination may be detected in patients diagnosed with ductal carcinoma in situ of the breast.

Tumor cell dissemination in bone marrow (BM) and lymph nodes is considered an important step in systemic disease progression and is associated with poor prognosis. Only invasive cancers are assumed to shed isolated tumor cells (ITC) into the bloodstream and infiltrate lymph nodes. However, latest studies indicate that tumor cell dissemination may occur before stroma invasion, i.e., in ductal carcinoma in situ (DCIS). Therefore, the purpose of this study was to examine the incidence of ITC in bone marrow and sentinel lymph nodes (SN) in patients diagnosed with DCIS and its correlation with clinicopathological factors. 266 patients who were treated at the Department of Gynecology and Obstetrics (University Hospital Tuebingen, Germany) between 2003 and 2009 with DCIS were included into this study. BM aspirates were analyzed by immunocytochemistry (pancytokeratin antibody A45-B/B3) using ACIS system (Chromavision) according to the ISHAGE evaluation criteria. SN were analyzed in 221 of these patients by extensive step sectioning and hematoxylin-eosin staining. In 34 of 266 patients (13%), ITC in BM could be detected. There was no correlation found between tumor size, grading, histology, or Van Nuys Prognostic Index and tumor cell dissemination. In two cases, metastatic spread into lymph nodes was observed (pN1mi), whereas in one case, ITC in lymph nodes were detected; however, additional sectioning and immunohistochemical staining of the primary lesion in the cases with positive SN did not reveal invasive cancer. Interestingly, all the three patients were BM negative. Tumor cell dissemination may be detected in patients diagnosed with DCIS. Either these cells have started already to disseminate from preinvasive mammary lesions or from occult invasive tumors or represent the earliest step of microinvasion in a preinvasive lesion. The clinical relevance of these cells has to be further evaluated.

Efficacy and safety of the novel electrosurgical vessel sealing and cutting instrument BiCision®.

BACKGROUND: The use of energy-based tissue-sealing and cutting instruments is becoming more and more popular in visceral, urological, and gynecological surgery. For their safe and efficacious use in clinical practice, such instruments have to reliably seal vessels with a minimal sealing failure rate, cause minimal thermal damage to adjacent tissue, and have good cutting qualities. METHODS: The efficacy and safety of the novel energy-based instrument for dissection, hemostasis and cutting (BiCision(®), ERBE) was compared to a commercially available device (EnSeal(®), Ethicon Endo-Surgery). We investigated vessel-sealing reliability (success rate), sealing quality and sealing time, lateral thermal damage cutting quality, tissue sticking to the instrument, burst pressure and delayed complications in an acute and chronic pig model after splenectomy, small bowel resection, nephrectomy, salpingo-oophorectomy, and sealing of peripheral vessels. RESULTS: For all parameters investigated, BiCision(®) was at least equivalent to EnSeal(®). BiCision(®) was even superior to EnSeal(®) with respect to the burst pressure in arteries (p = 0.044) and veins (p = 0.023) and the cut quality in all locations (arteries, p = 0.0009; veins, p = 0.043). The course of the 7-day chronic study was uneventful except for one animal that developed an intestinal obstruction. None of the animals showed any signs of postoperative bleeding. On second-look laparotomy at day 7, macroscopic inspection of the sealed tissue and vessels did not show any signs of complications or evidence that bleeding had occurred. Histologically, the integrity of vessel wall fusion, thermal alterations, and inflammatory reactions were comparable, confirming substantial equivalence. CONCLUSION: We demonstrated that the efficacy and quality of vessel sealing with BiCision(®) is at least equivalent to those of EnSeal(®) for vessel diameters up to 7 mm. Since EnSeal(®) has already been shown to be safe in clinical practice, BiCision(®) should be as reliable as EnSeal(®) under clinical conditions.

Influence of pregnancy on bone density: a risk factor for osteoporosis? Measurements of the calcaneus by ultrasonometry.

BACKGROUND: There are conflicting opinions in the literature about whether pregnancy influences maternal bone density or osteoporosis development. The study aim was to investigate whether there is a significant alteration in maternal bone density during normal pregnancy. METHODS: Bone mass of 200 pregnant women aged 22-42 years was measured twice with quantitative ultrasonometry (QUS) of the heel (Os calcaneum). The first measurement was performed between the 10th and 22nd week of pregnancy, follow-up of 149 women took place 0-9 days postpartum. A questionnaire focusing on data affecting bone metabolism and bone turnover was handed out at the first visit. RESULTS: Median reduction in speed of sound (SOS) was 11 m/s at follow-up indicating a decline of the stiffness during pregnancy. No significant correlation was found between lactation period and the obtained values for stiffness, SOS, T score and Z score. For broadband ultrasonographic attenuation, there was a statistically significant difference (p < 0.05) between women who had and had not breastfed. Parameters from patients with a family history of osteoporosis (n = 30) compared to patients without did not reveal statistical significance during pregnancy. Glucocorticoid therapy, nicotine consumption, physical exercise and nutrition was not statistically significant (p > 0.05). SOS value of women with a twin pregnancy was different over the study period (p < 0.05). CONCLUSION: A reduction in bone mass is possible during pregnancy. Routine evaluation of the bone density in all pregnant women does not seem to be justified; however, it is reasonable in women who present with risk factors. These women could be screened with QUS.

Clinical characteristics indicating adenomyosis at the time of hysterectomy: a retrospective study in 291 patients.

PURPOSE: To better characterize adenomyosis as a disease entity. METHODS: We retrospectively reviewed the medical records of women undergoing hysterectomy with a histologic diagnosis of adenomyosis, adenomyosis and leiomyomas, and leiomyomas alone. RESULTS: The study included 291 women: 38 with adenomyosis alone, 56 with adenomyosis and leiomyomas, and 197 with leiomyomas alone. In univariate analysis, women with adenomyosis were younger (p = 0.018) and had lower uterine weights (p < 0.001) and more disease-specific symptoms (p = 0.008). In multinomial logistic regression analysis, a lower uterine weight (OR 0.99, CI 95% 0.99-1.0), pelvic pain (OR 4.8, CI 95% 1.5-15.2), a history of smoking (OR 2.6, CI 95% 1.1-6.5) and at least one delivery (OR 4.3, CI 95% 1.5-12.3) were associated with a greater likelihood of having adenomyosis but not leiomyomas alone. CONCLUSIONS: Women undergoing hysterectomy with adenomyosis alone have different clinical characteristics from women with adenomyosis and leiomyomas and from those with only leiomyomas.

Laparoscopic transection and immediate repair of obturator nerve during pelvic lymphadenectomy.

Radical pelvic surgery including pelvic lymphadenectomy in the obturator fossa has become a routine endoscopically performed procedure in patients with gynecologic cancer. Nerve injury during these procedures is rare. However, to choose the best surgical procedure, the surgeon must be aware of the anatomical landmarks of the obturator fossa and of various injury mechanisms. Herein is presented the case of obturator nerve transection during laparoscopic pelvic lymph node dissection, radical vulvectomy, and inguinal lymphadenectomy and its immediate laparoscopic repair in a 56-year-old patient.