Laparoscopic in-bag morcellation - a comparison of two tissue extraction systems.

OBJECTIVES: Morcellation is an integral part of laparoscopic procedures related to uterine fibroids, which consist of the mechanical fragmentation of the tumor and its extraction outside the abdominal cavity. To avoid the risk of tissue dissemination, special extraction systems have been developed, which allow morcellation of the specimen under visual control and its removal without contact with the abdominal organs. The aim of the paper is to compare the two systems for laparoscopic morcellation. MATERIAL AND METHODS: The study included 33 premenopausal women with symptomatic leiomyomas or adenomyosis, who were qualified for laparoscopic surgery with contained power morcellation. Patients were allocated alternately to a different tissue extraction system's group. According to the study protocol, selected operative parameters were prospectively recorded. Finally, an assessment of bag use was performed. The data was statistically analyzed. RESULTS: There were significant differences between the two tested systems in terms of introducing and positioning the bag, its removal from the peritoneal cavity, as well as optic trocar insertion and establishing the pseudo-peritoneum. CONCLUSIONS: Despite the minor design differences and some ergonomic aspects, both presented systems proved to be safe and feasible tools for laparoscopic contained morcellation. This technique both reduces the risk of tissue dissemination and preserves the advantages of minimal invasiveness.

Diagnosis and Therapy of Female Genital Malformations (Part 1). Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/052, May 2019).

Objectives Female genital malformations may take the form of individual entities, they may involve neighboring organs or they may occur in the context of complex syndromes. Given the anatomical structures of the vulva, vagina, uterus and adnexa, the clinical picture of malformations may vary greatly. Depending on the extent of the malformation, organs of the urinary system or associated malformations may also be involved. Methods This S2k-guideline was developed by representative members from different medical specialties and professions as part of the guidelines program of the DGGG, SGGG and OEGGG. The recommendations and statements were developed using a structured consensus process with neutral moderation and voted on. Recommendations The guideline is the first comprehensive presentation of the symptoms, diagnosis and treatment options for female genital malformations. Additional chapters on classifications and transition were included.

Diagnosis and Therapy of Female Genital Malformations (Part 2). Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/052, May 2019).

Objectives Female genital malformations may be present in the form of individual entities, they may involve neighboring organs or they may occur in the context of complex syndromes. Given the anatomical structures of the vulva, vagina, uterus and uterine appendages, the clinical picture of malformations varies greatly. Methods This S2k-guideline was developed by representative members from different medical specialties and professions as part of the guidelines program of the DGGG, SGGG and OEGGG. The recommendations and statements were developed and voted on using a structured consensus process with neutral moderation. Recommendations This guideline is the first comprehensive summary of female genital malformations from infancy to adulthood which covers clinical examinations, diagnostic workups and treatment options. Additional chapters have been included on complex urogenital malformations, vascular malformations, psychosomatic care, and tumor risk.

Hormonal Contraception. Guideline of the DGGG, OEGGG and SGGG (S3 Level, AWMF Registry Number 015/015, January 2020).

Aims This is an official interdisciplinary guideline published and coordinated by the German Society for Gynecology and Obstetrics (DGGG), the Austrian Society for Gynecology and Obstetrics (OEGGG) and the Swiss Society for Gynecology and Obstetrics (SGGG). The guideline was developed for use in German-speaking regions and is backed by numerous professional societies and organizations. The aim of this guideline is to provide an evidence- and consensus-based overview of the diagnostic approach and the management of hormonal contraception based on a systematic evaluation of the relevant literature. Methods To compile this S3-guideline, a systematic search for evidence was carried out in PubMed and the Cochrane Library to adapt existing guidelines and identify relevant reviews and meta-analyses. A structured evaluation of the evidence was subsequently carried out on behalf of the Guidelines Commission of the DGGG, and a structured consensus was achieved based on consensus conferences attended by representative members from the different specialist societies and professions. Recommendations Evidence-based recommendations about the advice given to women requesting contraception were compiled. The guideline particularly focuses on prescribing contraceptives which are appropriate to women's individual needs, take account of her personal circumstances, and have few or no side effects.

Assessing practical laparoscopic training in certified Training Centers of the Gynecological Endoscopy Working Group (AGE) of the German Society of Gynecology and Obstetrics (DGGG).

PURPOSE: This study was performed to assess the practical laparoscopic training in Gynecological Endoscopy Working Group (AGE) certified Training Centers (TC) and evaluate the possible implementation for a manual dexterity skills-training within the Minimal Invasive Surgery (MIC) certification process. MATERIAL AND METHODS: An online questionnaire was developed and the link provided for the heads of the AGE TC. The questionnaire comprised topics on TC organization, practical training performance and perspectives for future training and demographic data. RESULTS: Response rate was 78.9% (15/19) of AGE TC. Grasping for the basic and suturing exercises for the advanced curricula, respectively, are thought to be of highest value (each 1.0 ± 0, on a scale from 1 = very valuable to 6 = not at all valuable). Most valuable parameter in assessing training was thought to be pressure/tension with 1.80 ± 1.08 The most valuable training capacity was considered for box training under supervision (1.27 ± 0.59) and feed-back box training with direct evaluation of various surgical skills (1.40 ± 0.63). Supervised box training was also thought to have the most positive influence on surgical performance (1.33 ± 0.49). The majority of respondents (86.7%) were qualified with the highest MIC certification and additional 66.7% were sub-specialized Gynecological Oncologists. CONCLUSION: The AGE certified TC offer a structured curriculum with emphasis on practical training. The results of this questionnaire and the additional respondents comments on value and future perspectives/changes of practical training support the concept and the implementation of a skills-training to the AGE MIC concept.

Report of the survey on current opinions and practice of German Society for Gynecologic Endoscopy (AGE) members regarding the laparoscopic treatment of ovarian malignancies.

PURPOSE: The purpose of this survey was to assess the opinions of members of the German Society of Gynecologic Endoscopy (AGE) regarding the laparoscopic treatment of ovarian malignancies and current practice at their institutions. METHODS: Between February and October 2015, the AGE sent an anonymous online survey via mail to its members. The questionnaire solicited participants' opinions about the laparoscopic treatment of ovarian cancers according to T stage and borderline tumors, and information about current practice at their institutions. Participants were also asked their opinions on currently available data on this issue. RESULTS: Of 228 AGE members who completed the survey, 132 (58%) were fellows or attending physicians and 156 (68%) worked at university hospitals or tertiary referral centers. Most [212 (93%)] respondents stated that < 10% of all ovarian cancer cases were currently treated laparoscopically at their institutions. Most participants indicated that T1 (a, b, c) tumors [145 (64%)] and ovarian borderline tumors [206 (90%)], but not T2 [48 (21%)] or T3/4 [9 (4%) ovarian tumors] should or could be treated laparoscopically. One hundred seventy-two (75%) participants considered currently available data on this topic to be insufficient and 152 (66%) stated that they would take part in a clinical trial assessing a laparoscopic approach to T1/2 ovarian cancer. CONCLUSION: According to this survey, to the opinion of the majority of AGE members, laparoscopy might be a considerable option for the treatment of early ovarian malignancies and borderline tumors and should be evaluated further in future studies.

In-Bag Morcellation as a Routine for Laparoscopic Hysterectomy.

Tissue morcellation during laparoscopic hysterectomy carries the risk of spreading cells from unsuspected malignancy. Contained morcellation inside a bag is supposed to minimize this risk. The present study evaluated routine use of in-bag morcellation during laparoscopic hysterectomy in a consecutive patient cohort (n = 49). The system used was More-Cell-Safe (A.M.I. Austria). Median age was 47 (35 to 76) years and BMI 25.1 (18.8 to 39.8). Indications for hysterectomy were fibroids (71.4%), adenomyosis (16.3%), prolapse (8.2%), and bleeding disorders (4.1%). 48 (98%) patients underwent supracervical hysterectomy and 1 (2%) underwent total hysterectomy. No unsuspected malignancy occurred. Median weight of extirpated tissue was 195 g (18 to 1110). Residual tissue and/or fluid in the bag amounted to 29 g (0 to 291). Median overall duration of surgeries was 100.5 min, and median time associated with the use of the bag was 10 min (5 to 28), significantly correlated with uterine volume (p = 0.0094) and specimen weight (p = 0.0002), but not with patient's BMI (p = 0.6970). Technical success rate for contained morcellation was 93.9%. Peritoneal washings after contained morcellation were all negative for malignant or smooth muscle cells.

First clinical experiences using a new in-bag morcellation system during laparoscopic hysterectomy.

INTRODUCTION: Endoscopic techniques have successfully reduced the invasiveness of hysterectomy, when compared to open procedures. Power morcellation, as a part of the minimal invasive concept, carries the risk of disseminating cells from the tissue specimen. The present observational study reports on first experiences using a new system (More-Cell-Safe, A.M.I., Austria) for contained in-bag morcellation during laparoscopic hysterectomy. MATERIALS AND METHODS: The dual opening system allows two-port access without bag puncture. The optic is protected against spread cell contamination with a disposable sleeve. Application data were prospectively recorded on the first n = 7 consecutive patients and compared to n = 7 preceding patients undergoing uncontained morcellation. RESULTS: Bag system use was surgically successful in 6 of 7 cases (85.7 %). Morcellated specimen weight ranged from 205 to 638 g (mean 413.33 ± 176.85; median 413). In one patient, the uterine specimen (1050 g) proved too large to be placed into the bag. Average time associated to the bag use was 16.2 ± 7.65 min, ranging from 8.5 to 26.5 min (median 14 min). Removed bags contained bloody fluid with residual tissue fragments weighing overall between 21 and 85 g. Spread spindle cells were detected in two cases after uncontained morcellation, but not after in-bag morcellation. CONCLUSION: The experiences from our small pilot series prove technical feasibility in the clinical setting.

A new in-bag system to reduce the risk of tissue morcellation: development and experimental evaluation during laparoscopic hysterectomy.

INTRODUCTION: Minimal invasive approaches have proven beneficial for patients undergoing myomectomy and hysterectomy, but necessary tissue morcellation carries the risk of cell dissemination in rare cases of inadvertent malignancy. Performing the morcellation process within a contained bag system may prevent spilling and therefore enhance safety of the laparoscopic procedures. MATERIAL AND METHODS: The present study describes the development and experimental evaluation of a new bag system in vitro and in vivo in a pig model of laparoscopic supracervical hysterectomies. RESULTS: The main results on n = 8 procedures with in-bag morcellation compared to n = 8 controls without bag indicate reproducible feasibility and protective effect of the new bag, which is the first published to our knowledge that does not require puncturing in a standard multiport laparoscopy setting. Overall surgery time was significantly prolonged in the bag group by 12.86 min (P = 0.0052; 95 % confidence interval 4.64-21.07), but peritoneal washings were negative for muscle cells in all cases with bag use, compared to positive cytology in 5/8 cases without bag (P = 0.0256). CONCLUSION: Clinical trials will now be necessary to investigate the reproducibility of these encouraging data in human application.

Expulsion of dominant submucosal fibroids after uterine artery embolization.

PURPOSE: Purpose of this study was to evaluate the frequency, probability, and factors associated with expulsion of submucosal fibroids after uterine artery embolization (UAE) in addition to the technical and clinical results at 1-year follow-up. MATERIALS AND METHODS: We determined the preinterventional volume of each dominant submucosal fibroid using the commonly used ellipsoid formula and a 3D volumetry in the MRI to define a threshold value in milliliters that indicates the probability for a fibroid expulsion. Assessment of fibroid expulsion was done by MRI at 3-month intervals for a year. Assessment of clinical mid term success was achieved by applying questionnaires at 1-year follow-up. RESULTS: Technical success was observed in all 20 patients (mean age of 41.4+/-5.6 years; range: 29.2-51.1 years). Two (10%) minor and one (5%) major complications occurred. 10/20 dominant submucosal fibroids were completely expelled during the follow-up. Using 3D MRI volumetry the preinterventional mean volume of the later expelled fibroids was 56.8+/-57.0 ml (range 2.3-198.0 ml) and the mean volume of non-expelled fibroids was 123.8+/-147.3 ml (range 24.0-531.8 ml). This difference was statistically significant, but weak (p=0.0494). Fibroids with a volume equal or less than the threshold value (66.0 ml) were 73% likely to be expelled and fibroids larger than 66.0 ml were 78% likely not to be expelled. All 20 patients demonstrated a significant reduction in the fibroid related symptoms. CONCLUSION: In our study the complication rate was low despite increased rates of fibroid expulsion (50%); simultaneously the rate of treatment satisfaction was very high. Patients with a dominant submucosal fibroid under 66.0 ml should be informed about the probability of fibroid expulsion and the accompanying symptoms.

Tubal abortions but not viable tubal pregnancies are characterized by an increased number of CD8+ T cells.

OBJECTIVE: To examine immune cell phenotypes in viable tubal pregnancies (VTP) and in tubal abortions (TA). METHODS: Paraffin-embedded specimens of VTP (n=7) and ongoing TA (n=6) were double-stained for cytokeratin for trophoblast as well as for CD45, CD3, CD8, CD68 and CD20 for immune cell phenotypes. In all cases, the amniotic sac was detected by ultrasound. Histological examination showed no evidence of necrosis within the tissues included in this study. Quantification of the subpopulations was performed in each slide by two independent examiners in five areas (0.085 mm2 each) of the invasion zone as marked by cytokeratin-positive stromal extravillous trophoblast (EVT) cells. For statistical analysis, the non-parametric two-tailed t-test was used (p<0.05). RESULTS: The differences in the number of CD45(+), CD68(+) and CD20(+) cells was significant (p=0.0423, p=0.0469 and p=0.0494, respectively); however, the number of CD3(+), and among those the number of CD8(+) cells, was approximately eight-fold higher in TA than in VTP (p<0.0001 and p=0.0012, respectively). CONCLUSION: The unequal distribution of CD8(+) cells in VTP and TA suggests a significant role of this immune cell phenotype in the further outcome of a tubal pregnancy either to an abortive or a viable, potentially life-threatening, entity.