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1.
Z Geburtshilfe Neonatol ; 228(1): 57-64, 2024 Feb.
Article En | MEDLINE | ID: mdl-38330960

INTRODUCTION: SARS-CoV-2 is a viral disease with potentially devastating effects. Observational studies of pregnant women infected with SARS-CoV-2 report an increased risk for FGR. This study utilizes data from a prospective SARS-CoV-2 registry in pregnancy, investigating the progression of fetuses to fetal growth restriction (FGR) at birth following maternal SARS-CoV-2 and evaluating the hypothesis of whether the percentage of SGA at birth is increased after maternal SARS-CoV-2 taking into account the time interval between infection and birth. MATERIALS & METHODS: CRONOS is a prospective German registry enrolling pregnant women with confirmed SARS-CoV-2 infection during their pregnancy. SARS-CoV-2 symptoms, pregnancy- and delivery-specific information were recorded. The data evaluated in this study range from March 2020 until August 2021. Women with SARS-CoV-2 were divided into three groups according to the time of infection/symptoms to delivery: Group I<2 weeks, Group II 2-4 weeks, and Group III>4 weeks. FGR was defined as estimated and/or birth weight<10% ile, appropriate for gestational age (AGA) was within 10 and 90%ile, and large for gestational age (LGA) was defined as fetal or neonatal weight>90%ile. RESULTS: Data for a total of 2,650 SARS-CoV-2-positive pregnant women were available. The analysis was restricted to symptomatic cases that delivered after 24+0 weeks of gestation. Excluding those cases with missing values for estimated fetal weight at time of infection and/or birth weight centile, 900 datasets remained for analyses. Group I consisted of 551 women, Group II of 112 women, and Group III of 237 women. The percentage of changes from AGA to FGR did not differ between groups. However, there was a significantly higher rate of large for gestational age (LGA) newborns at the time of birth compared to the time of SARS-CoV-2 infection in Group III (p=0.0024), respectively. CONCLUSION: FGR rates did not differ between symptomatic COVID infections occurring within 2 weeks and>4 weeks before birth. On the contrary, it presented a significant increase in LGA pregnancies in Group III. However, in this study population, an increase in the percentage of LGA may be attributed to pandemic measures and a reduction in daily activity.


COVID-19 , SARS-CoV-2 , Pregnancy , Female , Humans , Infant, Newborn , Birth Weight , Prospective Studies , COVID-19/epidemiology , Fetal Development , Fetal Growth Retardation/diagnosis , Fetal Growth Retardation/epidemiology , Gestational Age
2.
Anticancer Res ; 44(2): 497-501, 2024 Feb.
Article En | MEDLINE | ID: mdl-38307560

BACKGROUND/AIM: To date, magnetic resonance imaging (MRI) remains the gold standard for diagnosing breast implant rupture. As MRI is an expensive procedure with limited availability, the improvement of sonographic assessment is desirable. A potentially useful tool in this regard is elastography. To evaluate the diagnostic benefits of strain elastography and shear wave elastography under standardized conditions we developed an animal model. MATERIALS AND METHODS: An animal model was created by preparing an implant site in a chicken breast, imitating tissue layers covering a breast implant after mastectomy. Different broken and intact implants were inserted. Thereby, measurements were performed using strain elastography and shear wave elastography. For strain elastography, the resulting images were investigated on repeated patterns. The data generated by shear wave elastography were analyzed for significant differences between the ruptured and intact implants. RESULTS: The animal model using chicken breast generated realistic images and measurements comparable to those of a human breast. Hence, ruptured and intact implants could be compared under standardized conditions. Statistical analysis showed no significant difference between intact and ruptured implants with respect to the data generated by shear wave elastography. Qualitative analysis using strain wave elastography showed different patterns between intact and ruptured implants in the animal model. Intact implants showed a characteristic sonographic image of three layers in certain levels. CONCLUSION: Shear wave elastography does not seem to produce reliable data for the evaluation of breast implants, whereas qualitative analysis using strain elastography might be a useful tool to improve diagnostic accuracy.


Breast Implantation , Breast Implants , Breast Neoplasms , Elasticity Imaging Techniques , Humans , Female , Breast Implants/adverse effects , Elasticity Imaging Techniques/methods , Mastectomy , Sensitivity and Specificity
3.
In Vivo ; 38(1): 380-384, 2024.
Article En | MEDLINE | ID: mdl-38148063

BACKGROUND/AIM: Breast cancer was the most common cancer in women in 2020. Breast reconstruction is an elementary component of modern breast surgery. This is especially important after oncological treatments. This is a retrospective multicenter study comparing Diagon\Gel® 4Two implants with different implants chosen by the treating surgeon. Diagon\Gel® 4Two (Polytech Health & Aesthetics, Germany) are anatomical silicone implants. PATIENTS AND METHODS: A total of 209 patients underwent surgery. All patients were treated in the period from 2001 to 2019. All procedures were subcutaneous mastectomies. The surgical techniques used were either skin-sparing mastectomies or nipple-sparing mastectomies. Surgery was performed with Diagon/Gel® 4Two implant or treatment of choice implant by the treating physician. Endpoints were major and minor complication rates. The average follow-up time was 5 years. In total, 110 subjects were asked about their satisfaction with the treatment. RESULTS: A total of 155 procedures were performed in the Diagon/Gel® 4Two implant group. One hundred and sixty procedures were done in the comparison group. Concerning either minor or major complications, there were no significant differences between both groups. The postoperative patient survey showed high satisfaction scores for both. There was significantly higher patient satisfaction among the study participants in the Diagon/Gel® 4Two implant group compared to the comparison group (p<0.01). CONCLUSION: The Diagon/Gel® 4Two implants are safe alternatives in direct comparison to previously used breast implants. Our study even demonstrated a slight superiority concerning patient satisfaction. Based on this study, further implants can be compared concerning both the direct perioperative complication rate and patient satisfaction.


Breast Implantation , Breast Implants , Breast Neoplasms , Mammaplasty , Plastic Surgery Procedures , Female , Humans , Mammaplasty/adverse effects , Mammaplasty/methods , Breast Implantation/adverse effects , Breast Implantation/methods , Retrospective Studies , Breast Neoplasms/surgery , Breast Neoplasms/etiology , Patient Satisfaction
4.
Ultraschall Med ; 44(5): 520-536, 2023 Oct.
Article En, De | MEDLINE | ID: mdl-37072031

Alongside mammography, breast ultrasound is an important and well-established method in assessment of breast lesions. With the "Best Practice Guideline", the DEGUM Breast Ultrasound (in German, "Mammasonografie") working group, intends to describe the additional and optional application modalities for the diagnostic confirmation of breast findings and to express DEGUM recommendations in this Part II, in addition to the current dignity criteria and assessment categories published in Part I, in order to facilitate the differential diagnosis of ambiguous lesions.The present "Best Practice Guideline" has set itself the goal of meeting the requirements for quality assurance and ensuring quality-controlled performance of breast ultrasound. The most important aspects of quality assurance are explained in this Part II of the Best Practice Guideline.


Mammography , Ultrasonography, Mammary , Female , Humans , Mammography/methods
5.
In Vivo ; 36(5): 2255-2259, 2022.
Article En | MEDLINE | ID: mdl-36099097

BACKGROUND/AIM: Magnetic resonance imaging (MRI) is an important diagnostic tool in the detection of breast cancer. The Breast Center of the municipal Hospital Holweide, Cologne, annually cares for and treats patients with changes in the breast. A special problem is posed by Breast Imaging-Reporting and Data System (BI-RADS) 4 lesions. If a BI-RADS 4 finding is present, is a vacuum biopsy indicated in every case or, if there is already an indication for surgery due to other findings, can the corresponding finding be removed openly without histological clarification? We require real world data regarding the actual in-center likelihood of a BIRADS 4 lesion to be DCIS (Ductal carcinoma in situ) or invasive disease. PATIENTS AND METHODS: This is a retrospective study of 1,641 patients who received MRI examination in the radiological department of the municipal hospital Holweide in 2012 and 2013. Each BI-RADS 4 finding (or higher) classified by MRI was compared with the final histological result. RESULTS: 347 MRIs showed BI-RADS 4 findings or higher and 280 (80.7%) cases showed benign histology. In 67 (19.3%) cases, histology showed DCIS or invasive carcinoma. CONCLUSION: BI-RADS 4 lesions have a low probability of malignancy based on real-world data from this center. If there is already an indication for surgery due to other lesions, the patient can also be offered a simultaneous open biopsy in the context of the already initiated surgical treatment. Each center should know the sensitivity and specificity of the MRI imaging performed and counsel patients based on that.


Breast Neoplasms , Carcinoma, Intraductal, Noninfiltrating , Breast/diagnostic imaging , Breast/pathology , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/pathology , Carcinoma, Intraductal, Noninfiltrating/diagnostic imaging , Female , Humans , Magnetic Resonance Imaging/methods , Retrospective Studies
6.
Arch Gynecol Obstet ; 306(4): 1171-1176, 2022 10.
Article En | MEDLINE | ID: mdl-35377044

PURPOSE: Platelet-rich plasma (PRP) is widely used product, and meta-analyses showed this product to be beneficial when applied to a wound area. This study group has already demonstrated increased patient satisfaction and lower complication rates in breast cancer patients who received PRP after removal of their subcutaneous venous access device. This work is a follow-up analysis focusing on oncologic safety. Currently, there is no long-term data on the use of PRP products in cancer patients available yet. METHODS: Between the years 2012-2016, venous access device removal was supported with the application of Arthrex ACP® (Autologous Conditioned Plasma)-a PRP product to improve the wound-healing process. All surgeries were performed in the breast cancer center of the municipal hospital of Cologne, Holweide, Germany. 35 patients received an application of Arthrex ACP® after port removal compared to the control group of 54 patients. Endpoints were local recurrence-free, distant recurrence-free as well as overall survival. RESULTS: Median follow-up was 45 months. No (0) adverse events were shown for cancer recurrence within the subcutaneous venous access device scar area. Thus, there seems to be no local oncogenic potential of the PRP product. All other endpoints as well as any-cause death numerically favor PRP use. CONCLUSION: PRP products such as Arthrex ACP® seem to be oncological inert when applied after removal of subcutaneous access devices. This is the first study providing long-term data about overall survival, distant recurrence-free and local recurrence-free survival after applying PRP in high-risk cancer patients.


Breast Neoplasms , Platelet-Rich Plasma , Breast Neoplasms/complications , Breast Neoplasms/surgery , Chronic Disease , Cicatrix/etiology , Female , Humans , Neoplasm Recurrence, Local/complications , Treatment Outcome , Wound Healing
7.
In Vivo ; 36(3): 1285-1289, 2022.
Article En | MEDLINE | ID: mdl-35478103

BACKGROUND/AIM: Labor is induced in 1 out of 5 pregnancies. This is why we aimed to compare two different protocols of orally administered misoprostol for the induction of labor (IOL), with special regard to maternal and fetal outcome, delivery mode and duration. PATIENTS AND METHODS: One hundred and twenty four patients with a medical indication for IOL were divided into two groups: Group A (n=63), which initially received 50 µg misoprostol escalated to 100 and, subsequently, to 200 µg every 4 h with a daily maximum of 600µg, between 11/2007 and 01/2008; and Group B (n=61), which initially received 25 µg misoprostol followed by 100 µg every 4 h with a daily maximum of 300 µg, between 12/2009 and 04/2010. RESULTS: The mean administration-delivery interval was significantly lower in Group A (19.0 h) compared to Group B (27.1 h, p<0.05). Overall caesarean section rate, average birth weight, APGAR score, umbilical cord pH and meconium-stained fluid rates were similar between both groups. CONCLUSION: A higher dosage protocol of orally administered misoprostol significantly reduces the mean induction-delivery interval without increasing the risk for an adverse maternal or fetal outcome.


Misoprostol , Oxytocics , Apgar Score , Cesarean Section , Female , Humans , Infant, Newborn , Labor, Induced , Misoprostol/adverse effects , Oxytocics/adverse effects , Pregnancy
8.
Anticancer Res ; 42(4): 1925-1932, 2022 Apr.
Article En | MEDLINE | ID: mdl-35347012

BACKGROUND/AIM: The combination of pre-surgical clip placement and hook-wire guided surgery is considered the gold standard for adequately locating non-palpable lesions during breast conserving surgery. After surgical removal of the segment, radiography is required to confirm clip removal, increasing surgical time, post-surgical complication rates, and cost. PATIENTS AND METHODS: We performed a retrospective analysis, using the Faxitron® in-theater specimen radiography system, of the following primary endpoints: surgical time and complication rates. The secondary endpoints were cost effectiveness and clip-location rates. The Control cohort included breast conserving surgery patients prior to May 2019 (n=150) and the Validation cohort included breast conserving surgery patients after May 2019 (n=53). RESULTS: The analysis showed an improvement in surgical time when using the Faxitron® system, which is directly linked to a benefit in cost effectiveness. A numerical benefit in complication rates was also shown. A subgroup analysis showed a significant advantage in surgical time for breast conserving surgery plus sentinel node biopsy and open breast biopsies. CONCLUSION: Use of the Faxitron® system significantly reduces surgical time, which increases cost efficiency while maintaining a low complication rate.


Mastectomy, Segmental , Sentinel Lymph Node Biopsy , Costs and Cost Analysis , Humans , Mastectomy, Segmental/adverse effects , Radiography , Retrospective Studies
9.
Arch Gynecol Obstet ; 305(1): 169-177, 2022 01.
Article En | MEDLINE | ID: mdl-34189629

BACKGROUND: The current methods for calculating the ideal implant volume for breast reconstruction are based on pre- or intraoperative volume measurements of the existing breast volume and do not take into account the individual breast density of the woman. This study aims is to identify objective parameters that can help to improve the optimal implant selection. MATERIALS AND METHODS: This retrospective analysis includes 198 breast cancer patients who underwent mastectomy. Breast densities (ACR) measured in mammography and MRI were compared with the removed breast tissue weight and volume of the implants used. In addition, the resected weight was compared directly with the implant volume to calculate a mathematical function. RESULTS: There was no significant correlation between the ACR values and the resected weights [correlation coefficient: mammography:- 0.117 (p = 0.176), MRI - 0.033 (p = 0.756)]. A negative correlation between the implant volumes and both imaging methods could be demonstrated [correlation coefficient: mammography - 0.268; p = 0.002; MRI was - 0.200 (p = 0.055)]. A highly significant correlation between the resected weights and the implant volumes (correlation coefficient 0.744; p < 0.001) was observed. This correlation corresponds to a power function (y = 34.71 x0.39), in which any resected weight can be used for the variable x to calculate the implant volume. CONCLUSION: We were able to show that there is a significant correlation between the resected breast tissue and the implant volume. With our novel potency function, the appropriate implant volume can be calculated for any resected weight making it easier for the surgeon to choose a fitting implant in a simple and more objective manner.


Breast Implants , Breast Neoplasms , Mammaplasty , Breast Density , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Female , Humans , Mammaplasty/methods , Mastectomy/methods , Retrospective Studies
10.
Arch Gynecol Obstet ; 305(3): 631-639, 2022 03.
Article En | MEDLINE | ID: mdl-34842976

PURPOSE: There is a novel surgical procedure, called cervicosacropexy (CESA) and vaginosacropexy (VASA) to treat pelvic organ prolapse and a concomitant urgency and mixed urinary incontinence. As there is little experience with the tapes so far and literature is scanty, the aim of this study was to investigate biomechanical properties for the fixation of the PVDF-tapes with three different fixation methods in context of apical fixations. METHODS: Evaluation was performed on porcine, fresh cadaver sacral spines. A total of 40 trials, divided into 4 subgroups, was performed on the anterior longitudinal ligament. Recorded biomechanical properties were displacement at failure, maximum load and stiffness in terms of the primary endpoints. The failure mode was a secondary endpoint. Group 4 was a reference group to compare single sutures on porcine tissue with those on human tissue. Biomechanical parameters for single sutures on the human anterior longitudinal ligament were evaluated in a previous work by Hachenberg et al. RESULTS: The maximum load for group 1 (two single sutures) was 65 ± 12 N, for group 2 (three titanium tacks arranged in a row) it was 25 ± 10 N and for group 3 (three titanium tacks arranged in a triangle) it was 38 ± 12 N. There was a significant difference between all three groups. The most common failure mode was a "mesh failure" in 9/10 trials for groups 1-3. CONCLUSION: The PVDF-tape fixation with two single sutures endures 2.6 times more load than titanium tacks arranged in a row and 1.7 times more load than titanium tacks arranged in a triangle. The presacral fixation with titanium tacks reduced surgical time compared to the fixation with sutures, nevertheless sutures represent the significantly stronger and cheaper fixation method.


Laparoscopy , Pelvic Organ Prolapse , Animals , Biomechanical Phenomena , Humans , Laparoscopy/methods , Pelvic Organ Prolapse/complications , Pelvic Organ Prolapse/surgery , Sacrum/surgery , Suture Techniques , Sutures , Swine
11.
Surg Oncol ; 40: 101675, 2022 Mar.
Article En | MEDLINE | ID: mdl-34871867

BACKGROUND: Skin/nipple-sparing mastectomies (SSM/NSSM) have been reported to have acceptable complication rates and good aesthetic outcomes with high patient satisfaction. However, in this relatively young and rapidly expanding field of reconstructive plastic surgery, differences in perioperative management are noted between breast centers. Prospective studies of complication rates using a titanized polypropylene mesh (TiLOOP® Bra) are currently lacking. METHODS: A prospective subgroup analysis was performed based on the data set of the prospective, single-arm, multicenter observational study (PRO-BRA). Early complication rates after skin/nipple-sparing mastectomy with implant-based immediate or secondary reconstruction using a titanized polypropylene mesh (TiLOOP® Bra) subpectorally were investigated in relation to demographic factors, as well as intra-and postoperative management. The subgroup consists of 258 patients. Complications were categorised into necrosis, infection, postoperative bleeding or hematoma, seroma, wound healing delays and R1-situations. RESULTS: Early complication rates of SSM/NSSM using titanium-based meshes are comparable to complication-rates using ADM's. Logistic regression shows significantly higher risk for wound healing delays, necrosis and seroma with increasing BMI, abladat- and implant-weight (OR 1,17 -1,66, p-value < 0,001). Smokers have significantly higher necrosis rates (20.7%) compared to non-smokers (5.5%) (p-value = 0.002). Discharge with drainage results in a trend toward higher rates of wound healing complications. CONCLUSION: The use of TiLOOP® Bra meshes was shown to have acceptable complication rates. Complication rates depend on certain demographic and intraoperative risk factors and should be considered in indications and information of patients.


Breast Implantation/adverse effects , Breast Neoplasms/surgery , Mammaplasty/adverse effects , Mastectomy/adverse effects , Postoperative Complications/epidemiology , Surgical Mesh/adverse effects , Adult , Aged , Breast Neoplasms/pathology , Female , Humans , Middle Aged , Polypropylenes , Retrospective Studies , Young Adult
12.
Arch Gynecol Obstet ; 305(3): 641-649, 2022 03.
Article En | MEDLINE | ID: mdl-34845538

PURPOSE: Many different surgical approaches have been established for the repair of a pelvic organ prolapse. Especially in laparoscopic surgery, it is important to generate easy surgical techniques with similar stability. This study shall simplify the choice of mesh by evaluating three polypropylene meshes regarding their biomechanical properties. METHODS: Biomechanical testing was performed in the porcine model. The meshes are fixated on porcine fresh cadaver cervices after subtotal hysterectomy. The apical part of the mesh is fixated with parallel screw clamps at the testing frame. Forty-one trials were performed overall, subdivided into four subgroups. The groups differ in mesh type and fixation method. Maximum load, displacement at failure and stiffness parameters were evaluated with an Instron 5565® test frame. RESULTS: SERATEX® E11 PA (E11) showed the highest values for maximum load (199 ± 29N), failure displacement (71 ± 12 mm) and stiffness (3.93 ± 0.59 N/mm). There was no significant difference in all three evaluated parameters between SERATEX® B3 PA (B3) and SERATEX® SlimSling® with bilateral fixation (SSB). SERATEX® SlimSling® with unilateral fixation (SSU) had the lowest stiffness (0.91 ± 0.19 N/mm) and maximum load (30 ± 2 N) but no significant difference in displacement at failure. CONCLUSION: All meshes achieved a good tensile strength, but the results of maximum load show that the E11 is superior to the other meshes. Through a bilateral fixation of SERATEX® SlimSling®, a simple operating method is generated without a loss of stability.


Pelvic Floor , Pelvic Organ Prolapse , Animals , Biomechanical Phenomena , Female , Pelvic Floor/surgery , Pelvic Organ Prolapse/surgery , Polypropylenes , Surgical Mesh , Swine , Tensile Strength
13.
Ultraschall Med ; 43(6): 570-582, 2022 Dec.
Article En, De | MEDLINE | ID: mdl-34921376

For many years, breast ultrasound has been used in addition to mammography as an important method for clarifying breast findings. However, differences in the interpretation of findings continue to be problematic 1 2. These differences decrease the diagnostic accuracy of ultrasound after detection of a finding and complicate interdisciplinary communication and the comparison of scientific studies 3. In 1999, the American College of Radiology (ACR) created a working group (International Expert Working Group) that developed a classification system for ultrasound examinations based on the established BI-RADS classification of mammographic findings under consideration of literature data 4. Due to differences in content, the German Society for Ultrasound in Medicine (DEGUM) published its own BI-RADS-analogue criteria catalog in 2006 3. In addition to the persistence of differences in content, there is also an issue with formal licensing with the current 5th edition of the ACR BI-RADS catalog, even though the content is recognized by the DEGUM as another system for describing and documenting findings. The goal of the Best Practice Guideline of the Breast Ultrasound Working Group of the DEGUM is to provide colleagues specialized in senology with a current catalog of ultrasound criteria and assessment categories as well as best practice recommendations for the various ultrasound modalities.


Breast Neoplasms , Medicine , Female , Humans , Ultrasonography, Mammary/methods , Mammography/methods , Breast Neoplasms/diagnostic imaging
14.
J Pers Med ; 13(1)2022 Dec 28.
Article En | MEDLINE | ID: mdl-36675725

Deep inferior epigastric artery flaps (DIEP) represent the gold standard of autologous breast reconstruction. Due to significant variations in vascular anatomy, preoperative perforator mapping (PM) is mandatory in order to ensure the presence of a sufficient perforator within the flap. In this regard, CT angiography (CTA) is currently the method of choice. Therefore, we investigated the value of contrast-enhanced ultrasound (CEUS) techniques for preoperative PM in comparison to CTA. Patients underwent PM, utilizing both CTA and CEUS techniques. Documentation included the course of the vascular pedicle through the rectus muscle (M), fascial penetration (F), the subcutaneous plexus (P) and the skin point (SP) on either side of the abdomen. Thus, contrast-enhanced B-Flow (BCEUS), B-Flow ultrasound (BUS), CEUS, color Doppler ultrasound (CDUS) and CTA were evaluated in terms of the diagnostic consistency and effectiveness of PM. Precision (∆L) was then calculated in relation to the actual intraoperative location. Statistical analysis included Kruskall-Wallis, Levene and Bonferroni tests, as well as Spearman correlations. A total of 39 DIEP flaps were analyzed. Only CTA (∆L = 2.85 mm) and BCEUS (∆L = 4.57 mm) enabled complete PM, also including P and SP, whereas CDUS, CEUS and BUS enabled clear PM throughout M and F only. Regarding the number of detected perforators, PM techniques are ranked from high to low as follows: CTA, BCEUS, BUS, CEUS and CDUS. CTA and BCEUS showed sufficient diagnostic consistency for SP, P and F, while CDUS and CTA had a superior performance for M. BCEUS offers precise image-controlled surface tags and dynamic information for PM without imposing radiation and may, therefore, be considered a feasible add-on or alternative to CTA. However, BCEUS requires an experienced examiner and is more time-consuming.

15.
Cancer Med ; 10(19): 6714-6724, 2021 10.
Article En | MEDLINE | ID: mdl-34402196

BACKGROUND: Prior research has shown that around 5%-7% of patients in breast cancer centers in Germany participate in the discussion of their own case within a multidisciplinary tumor conference (MTC). The PINTU study is one of the first to research this practice. The objective is to describe (a) how patient participation in MTCs is implemented, (b) what is the role of patients, and (c) how patients experience MTCs. METHODS: MTCs in six breast and gynecological cancer centers in North Rhine-Westphalia, Germany, with and without patient participation, are studied prospectively by (non)participatory, structured observation. Breast and gynecological cancer patients completed surveys before, directly after, and 4 weeks after MTC participation. Data are analyzed descriptively. RESULTS: Case discussions of a sample of n = 317 patients (n = 95 with MTC participation and n = 222 without) were observed. Survey data were obtained from n = 242 patients (n = 87 and n = 155). Observational data showed heterogeneity in the ways MTC participation was practiced. Among participating patients, 89% had the opportunity to express their opinion and 61% were involved in decision-making. Whereas most patients reported positive experiences and would recommend participation, some had negative experiences and regretted participating. CONCLUSIONS: Due to a lack of recommendations, hospitals implement patient participation in MTCs in many different ways. So far, it is unknown which setting and procedures of MTC participation are beneficial for patients. However, existing evidence on communication in cancer care together with this exploratory study's findings can build the basis for developing recommendations for hospitals that invite their patients to MTCs. CLINICAL TRIAL REGISTRATION NUMBER: German Clinical Trials Register Nr. DRKS00012552.


Interdisciplinary Studies/statistics & numerical data , Patient Participation/statistics & numerical data , Decision Making , Female , Humans , Male , Middle Aged
16.
Breast J ; 27(4): 363-368, 2021 04.
Article En | MEDLINE | ID: mdl-33619792

Subcutaneous nipple sparing mastectomies (NSM) are an important tool in modern oncoplastic surgery. Especially when an immediate implant-based reconstruction (IBR) is desired, clean margins are of the utmost importance. Central nipple biopsies during surgery serve two main purposes. Most importantly, it is hypothesized that intraoperative pathological evaluation of this biopsy may increase clean margin resection rates. In addition, a general recurrence risk reduction may occur due to the elimination of glandular and ductal components within the nipple. This analysis is a single center, multi-surgeon, retrospective, head to head analysis. Starting in March 2015, intraoperative central nipple biopsy in NSMs with IBR was introduced at the Municipal Breast Cancer Centre Cologne, Holweide, Germany. This trial retrospectively evaluates global complication rates, clean margin status and local recurrence rates for cohort 1 (NSM/no nipple biopsy, n = 103) vs. cohort 2 (NSM with nipple biopsy, n = 108) Median follow-up was 15 months. All implant-based reconstruction procedures used an epipectoral implant pocket. Cohorts were comparable. Global complication rates slightly favored the nipple biopsy cohort with respects to implant loss rate. An involved central nipple biopsy was found in 4.6% (n = 5/108) of the performed NSM procedures leading to the immediate removal of the nipple areola complex. All positive retro-areolar biopsies correlated with a positive nipple biopsy. However, in n = 1 case we found DCIS discontinual proliferation with an involved nipple biopsy, without a correlating positive retro-areolar biopsy (ie, 1 false-negative case was prevented). For the 15 month follow-up, there was no case of local recurrence within nipple areola complex for both cohorts. With this retrospective head to head analysis of 211 patients, it was shown that the central nipple biopsy correlates well with the retro-areolar biopsy. There may be a reduction in false negative rates. The procedure is safe to use and should be offered to NSM patients.


Breast Neoplasms , Mammaplasty , Mastectomy, Subcutaneous , Biopsy , Breast Neoplasms/surgery , Female , Germany , Humans , Mastectomy , Mastectomy, Subcutaneous/adverse effects , Neoplasm Recurrence, Local , Nipples/surgery , Retrospective Studies
17.
In Vivo ; 35(1): 549-554, 2021.
Article En | MEDLINE | ID: mdl-33402508

BACKGROUND/AIM: Postoperative infection in implant-based reconstructive breast surgery is a common problem. The preoperative application of a disinfecting washing agent may reduce postoperative infection rates. This retrospective analysis aimed to evaluate whether preoperative Octenisan® application yields a reduction in postoperative complications or infection rates in breast reconstructive surgery. PATIENTS AND METHODS: Between 2016 and 2019, 127 women received implant-based breast reconstruction at the municipal hospital of Cologne, Holweide, Germany. A total of 197 treatments were performed. After giving consent, patients were asked to use Octenisan® wash lotion for five days before breast reconstructive surgery. All patients were asked by a simple questionnaire whether they performed showering and washing according to the proposed protocol. In 96 cases patients did adhere to the protocol. In 101 cases they did not. Patient cohorts were then divided into patients who had applied Octenisan® wash lotion and patients who had not. Endpoints were defined as minor complications with no implant loss and major complications with consecutive implant loss. RESULTS: Patient adherence to the application regimen was 48.7%. Overall minor complications occurred in 34.4% with preoperative Octenidine usage and 36.6% without preoperative Octenidine usage. Major complications happened in 7% with preoperative Octenidine and 5% without Octenidine. Overall, there was no significant difference concerning minor or major complication rates. CONCLUSION: Preoperative washing protocols involving the Octenisan® wash lotion is relatively cheap and easy to follow. There is evidence that washing protocols result in a reduction of S. aureus infections leading to a better perioperative outcome. Octenisan® is safe to use in implant-based breast reconstructive surgery and is not associated with higher risks for patients. Our study did not yield any significant reduction in perioperative and postoperative complication and infection rates. This is attributed to a relatively low study population. Wash lotion compliance was only 48.7%. Proper patient education is crucial. With those preliminary data, it is now possible to design a larger analysis since patient adherence to washing protocol with Octenisan® wash lotion has been established.


Breast Implantation , Breast Implants , Breast Neoplasms , Mammaplasty , Breast Implantation/adverse effects , Female , Germany , Humans , Imines , Postoperative Complications/prevention & control , Pyridines , Retrospective Studies , Staphylococcus aureus
18.
In Vivo ; 34(6): 3341-3347, 2020.
Article En | MEDLINE | ID: mdl-33144441

BACKGROUND/AIM: In Germany, performance of an emergency Cesarean section (ECS) is recommended within an interval of ≤20 min from decision to delivery (DDI). The aim of the study was to assess the duration of DDI in ECS as well as its impact on neonatal outcome. PATIENTS AND METHODS: Data from 437 patients at a single, tertiary care hospital were retrospectively analysed regarding influence on the duration of DDI. Subsequently the impact of DDI on neonatal outcome and incidence of adverse neonatal outcome was analysed. RESULTS: DDI of ECS performed outside core working hours was significantly prolonged (p<0.001). Shorter DDI showed a statistically worse arterial cord blood pH (p=0.001, r=0.162) and base excess (p=0.05; r=0.094). Duration of DDI had no significant impact on the incidence of adverse neonatal outcome (p=0.123). CONCLUSION: Awareness of influence on DDI might contribute to expediting DDI, but duration of DDI showed no impact on the incidence of adverse neonatal outcome. Data were not adequate to suggest a recommendation for DDI time standards.


Cesarean Section , Pregnancy Outcome , Emergency Treatment , Female , Germany/epidemiology , Humans , Infant, Newborn , Pregnancy , Pregnancy Outcome/epidemiology , Retrospective Studies , Time Factors
19.
Breast Care (Basel) ; 15(4): 355-365, 2020 Aug.
Article En | MEDLINE | ID: mdl-32982645

BACKGROUND: Breast cancer is a very heterogeneous disease and luminal breast carcinomas represent the hormone receptor-positive tumors among all breast cancer subtypes. In this context, multigene signatures were developed to gain further prognostic and predictive information beyond clinical parameters and traditional immunohistochemical markers. SUMMARY: For early breast cancer patients these molecular tools can guide clinicians to decide on the extension of endocrine therapy to avoid over- and undertreatment by adjuvant chemotherapy. Beside the predictive and prognostic value, a few genomic tests are also able to provide intrinsic subtype classification. In this review, we compare the most frequently used and commercially available molecular tests (OncotypeDX®, MammaPrint®, Prosigna®, EndoPredict®, and Breast Cancer IndexSM). Moreover, we discuss the clinical utility of molecular profiling for advanced breast cancer of the luminal subtype. KEY MESSAGES: Multigene assays can help to de-escalate systemic therapy in early-stage breast cancer. Only the Oncotype DX® and MammaPrint®test are validated by entirely prospective and randomized phase 3 trials. More clinical evidence is needed to support the use of genomic tests in node-positive disease. Recent developments in high-throughput sequencing technology will provide further insights to understand the heterogeneity of luminal breast cancers in early-stage and metastatic disease.

20.
In Vivo ; 34(4): 2015-2019, 2020.
Article En | MEDLINE | ID: mdl-32606175

BACKGROUND/AIM: Surgical margin status remains an important determinant for recurrence of invasive breast cancer and ductal carcinoma in situ. We compared the number of positive margins in initial histology with rates of residual tumor in re-excision specimens. Furthermore, we analysed cost-effectiveness of re-excisions. PATIENTS AND METHODS: 101 patients treated with secondary surgery were included. The first group underwent breast conserving surgery and secondary mastectomy. The second group was primarily treated with subcutaneous mastectomy followed by secondary surgery. RESULTS: Within the first group, 22.7% did not show residual tumor in the re-excision specimen. Of the second group, 54.3% had no residual tumor. Consequentially 45.7% needed a re-excision to achieve R0 status. Cost-effectiveness was determined as secondary endpoint. If a patient needs a secondary mastectomy the hospital gains 602,65€ in comparison to a primary breast conserving operation. CONCLUSION: In every second patient who had first received a subcutaneous mastectomy, no tumor could be detected in the secondary operation despite a previous R1 status.


Breast Neoplasms , Carcinoma, Ductal, Breast , Carcinoma, Intraductal, Noninfiltrating , Mastectomy, Subcutaneous , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/surgery , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Humans , Mastectomy , Neoplasm Recurrence, Local/surgery , Neoplasm, Residual/surgery , Reoperation , Retrospective Studies
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