Major complications after intraoperative radiotherapy with low-energy x-rays in early breast cancer.

PURPOSE: To describe and analyze major local complications after intraoperative radiotherapy (IORT) with low-energy x­rays during breast-conserving surgery (BCS) in early breast cancer. METHODS: Ten women out of 408 who were treated with IORT between 2002 and 2017 and subsequently developed a severe local complication requiring surgical intervention were retrospectively identified and analyzed. Demographic, clinical, and surgical parameters as well as complication characteristics and treatment methods were evaluated. RESULTS: At initial presentation, eight patients (80%) showed redness, six (60%) seroma, six (60%) wound infection, six (60%) suture dehiscence, and four (40%) induration of the former surgical area. Hematoma and necrosis were observed in one case (10%) each. Time interval until appearance of the first symptoms ranged from directly postoperative until 15 years postoperatively (median 3.1 months). Initial treatment modalities comprised antibiotic therapy (n = 8/80%) and transcutaneous aspiration of seroma (n = 3/30%). In the majority of patients, smaller surgical interventions (excision of a necrotic area/fistula [n = 6/60%] or secondary suture [n = 5/50%]) were sufficient to overcome the complication, yet larger interventions such as complex flap surgery and mastectomy were necessary in one patient each. CONCLUSION: IORT is an efficient and safe treatment method as < 2.5% of all IORT patients experienced major local complications. However, it seems to pose the risk of causing severe local complications that may require lengthy and burdensome treatment. Thorough preoperative counseling, implementation of recommended intraoperative precautions, and high vigilance for first symptoms of complications during follow-up appointments are necessary measures.

Intraoperative radiotherapy (IORT) of early breast cancer with low-energy x-rays in breast-conserving surgery : Prospective identification of pre- and intraoperative factors influencing the feasibility of IORT.

PURPOSE: The aim of this study is to identify pre- and intraoperative factors indicating the feasibility of intraoperative radiotherapy (IORT) during breast-conserving surgery (BCS). MATERIALS AND METHODS: From January 2018 to December 2019, a total of 128 women undergoing BCS due to early breast cancer were included in this prospective observational study, independent of whether IORT was planned or not. Patient and tumor characteristics as well as surgical parameters that could potentially influence the feasibility of IORT were recorded for the entire collective. In addition, a preoperative senological assessment was performed and analyzed to assess the feasibility of IORT. Logistic regression was then used to identify relevant preoperative parameters and to generate a formula predicting the feasibility of IORT. RESULTS: Of the 128 included women undergoing BCS, 46 were preoperatively rated to be feasible, 20 to be questionably feasible for IORT. Ultimately, IORT was realized in 30 patients. The most frequent reasons for omission of IORT were insufficient tumor-to-skin distance and/or an excessively large tumor cavity. Small clinical tumor size and large tumor-to-skin distance according to preoperative ultrasound were significantly related to accomplishment of IORT. CONCLUSION: We observed that preoperative ultrasound-based tumor-skin distance is a significant factor in addition to already known parameters to predict feasibility of IORT. Based on our findings we developed a formula to optimize IORT planning which might serve as an additional tool to improve patient selection for IORT in early breast cancer.

Prevalence of higher-grade dysplasia in persistently high-risk human papillomavirus positive, cytology negative women after introduction of the new cervical cancer screening in Germany.

PURPOSE: According to the recently implemented organized cervical cancer screening program in Germany, women older than 35 years with negative cytology but persistent high-risk human papilloma virus (hrHPV) infection > 12 months should be referred to colposcopy for further evaluation. This study aimed to present and dissect colposcopic and histopathological findings with particular focus on associated hrHPV genotypes. METHODS: This study is a retrospective analysis of clinical data from 89 hrHPV positive patients with normal cytology who underwent colposcopic examination at a certified dysplasia outpatient clinic in Germany in 2021. RESULTS: While 38 (43%) women had a normal colposcopic finding, 45 (51%) had minor and 6 (7%) major changes. Thirty-one (35%) of the women were HPV 16 and/or HPV 18 positive and 58 (65%) women were positive for other hrHPV only. Among patients who underwent colposcopy with biopsies (in case of an abnormal finding or type 3 transformation zone, n = 68), eight (12%) had cervical intraepithelial neoplasia (CIN) 3 and six (9%) had CIN 2. The proportion of women diagnosed with CIN 3 varied among different hrHPV genotypes (HPV 16: 11%, HPV 18: 33%, HPV 31: 27%, HPV 33: 33%, HPV 52: 33%). CONCLUSION: Persistently hrHPV positive women with negative cytology are at increased risk of being diagnosed with CIN 3. As CIN 3 prevalence seems to differ with regard to hrHPV strain, immediate HPV genotyping for risk stratification and subsequent early referral for colposcopy might constitute a feasible strategy.

First experiences with a diode laser in major gynecological laparoscopic procedures show lack of benefit and impaired feasibility.

PURPOSE: The aim of this study is to evaluate feasibility and potential benefit of a diode laser in major laparoscopic procedures in gynecology. METHODS: Between 2018 and 2020, a total of 42 cases were enrolled in this study comparing standard electrosurgery with diode laser-supported therapy in laparoscopic supracervical hysterectomy (LASH), total laparoscopic hysterectomy (TLH), or laparoscopic myoma enucleation (LME). Dual wavelength 45 W diode laser light was used to cut and coagulate during laparoscopy in the prospective interventional arm consisting of 11 cases, while 31 matching patients who received conventional treatment with monopolar/bipolar current for the same interventions were retrospectively identified in our laparoscopy database. Recruitment in the prospective interventional laser diode arm was terminated after only 11 patients (instead of planned 50) due to intense hemorrhage and massive smoke development. RESULTS: A total of 42 cases were analyzed (11 LME, 19 LASH, and 12 TLH). Strong smoke development was evident in all 11 cases in the diode laser arm. It was necessary to convert to bipolar or monopolar current in all hysterectomies (n = 9) with initial diode laser implementation due to increased bleeding and smoke development. Conventional current sources had to be used in LMEs (n = 2) due to excessive bleeding and poor visibility during enucleation of the fibroid. A significant difference (p < 0.0001) was observed regarding smoke development when comparing the laser arm with the control arm. CONCLUSION: We found a 45-W diode laser to be inferior to electrosurgical techniques for major laparoscopic gynecologic surgeries regarding bleeding control and smoke development.

Long-term evaluation of uterine fibroid embolisation using MRI perfusion parameters and patient questionnaires: preliminary results.

BACKGROUND: Uterine fibroid embolisation (UFE) is an established treatment method for symptomatic uterine myomas. This study evaluates the efficacy of UFE using objective magnetic resonance imaging (MRI) data for size and perfusion analysis as well as patient questionnaires assessing fibroid-related symptoms. METHOD: Patients underwent MR-Angiography before UFE and 4 days, 6 and 12 months after the procedure. The images were evaluated using dedicated software. Patient questionnaires were completed before UFE and at 12 months follow-up, focussing on the embolization procedure and symptoms associated with uterine fibroids. Statistical analysis of the questionnaires was performed using paired sample t-test and Wilcoxon signed rank test, while Kruskal-Wallis test and Friedman test were applied for MRI-analysis. RESULTS: Eleven women were included. There was a significant reduction in fibroid-related symptoms. The volume reduction after 12 months was significant in both, uterus and myomas, after an initial increase in uterine volume at the first post-interventional MRI. The perfusion analysis showed that blood flow to the fibroids could be significantly reduced up to 12 months after UFE while uterine tissue was not affected. CONCLUSION: This study shows that uterine fibroid embolisation induces a significant long-term decrease in myoma size and perfusion while healthy uterine tissue remains unaffected. Fibroid-related symptoms are reduced for the sake of improved quality of life.

Cardiac serum marker alterations after intraoperative radiotherapy with low-energy x-rays in early breast cancer as an indicator of possible cardiac toxicity.

PURPOSE: To assess acute cardiac toxicity caused by intraoperative radiotherapy (IORT) with low-energy x­rays for early breast cancer. METHODS: We prospectively analyzed pre- and postoperative troponin I and NT-proBNP in 94 women who underwent breast-conserving surgery between 2013 and 2017 at the Department of Gynecology and Obstetrics of the University Medical Center Mannheim, Germany. Thirty-nine women received IORT using low-energy x­rays during breast-conserving surgery while 55 patients without IORT formed the control group. Demographic and surgical parameters as well as cardiac markers were evaluated. RESULTS: There were no significant differences concerning age and side of breast cancer between the groups. Furthermore, no significant difference between the troponin I assays of the IORT and control groups could be found (preoperatively: 0.017 ± 0.006 ng/ml vs. 0.018 ± 0.008 ng/ml; p = 0.5105; postoperatively: 0.019 ± 0.012 ng/ml vs. 0.018 ± 0.010 ng/ml; p = 0.6225). N­terminal fragment of B­type natriuretic peptide (NT-proBNP) was significantly higher in the control group 24 h after surgery (preoperatively: 158.154 ± 169.427 pg/ml vs. 162.109 ± 147.343 pg/ml; p = 0.56; postoperatively: 168.846 ± 160.227 pg/ml vs. 232.527 ± 188.957 pg/ml; p = 0.0279). CONCLUSION: Troponin I levels as a marker of acute cardiac toxicity did not show any significant differences in patients who received IORT during breast-conserving surgery compared to those who did not.

Female genital injury-which findings have to be considered physiological using colposcopy with and without toluidine blue dye?

This study aimed to assess the validity and efficacy of blue dye in colposcopic assessment of genital injury in pre- and postmenopausal women with and without history of consensual sexual intercourse. Two hundred women were prospectively enrolled and examined colposcopically with and without toluidine blue dye in order to detect and categorize genital lesions (laceration, bruise and abrasion). Examination of genital trauma was accomplished in a standardized way and findings were photo documented. A wide range of influencing factors with a potential impact on prevalence and nature of genital injury was recorded beforehand using a questionnaire. The frequency of diagnostic injury differed substantially depending on the examination technique, ranging from 9% using colposcopic magnification only to 28% with the additional use of toluidine blue dye. A vertical laceration affecting the posterior fourchette was the most frequent lesion detected (17%, n = 32). Menopausal status seems to have significant impact on genital injury prevalence (p = 0.0165), as 42% (16/ 38) of postmenopausal compared to 24% (36/ 151) of premenopausal women had at least one genital lesion. Furthermore, vaginal medication (p = 0.0369), vaginal dryness (p = 0.0228), dyspareunia (p = 0.0234) and low frequency of sexual intercourse (p = 0.0022) were found to significantly correlate with the presence of genital lesions. According to our findings, standardized colposcopy in combination with toluidine blue dye facilitates accurate assessment of genital lesions. Genital trauma situated at another site than the posterior part of the vaginal introitus seems to be uncommon after consensual intercourse.

Intraoperative radiotherapy for breast cancer treatment efficiently targets the tumor bed preventing breast adipose stromal cell outgrowth.

OBJECTIVES: Mesenchymal stromal cells (MSC) in bone marrow have been shown to be radioresistant, which is related to pronounced DNA repair mechanisms. Intraoperative radiotherapy (IORT) during breast-conserving surgery for early breast cancer is an innovative technique applying low energy x­ray to the tumor bed immediately after removal of the tumor. IORT is considered to reduce the risk of local tumor recurrence by directly targeting cells of the tumor bed and altering the local microenvironment. Aim of this study was to investigate whether IORT affects the outgrowth potential of breast adipose tissue-derived MSC (bASC) as part of the tumor bed. MATERIALS AND METHODS: After surgical tumor resection, biopsies of the tumor bed were taken before (pre IORT) and after IORT (post IORT) and processed applying well-established protocols for ASC isolation and characterization. RESULTS: In all, 95% of pre IORT tumor bed samples yielded persistently outgrowing bASC with typical ASC characteristics: fibroblastoid morphology, proliferation, adipogenic and osteogenic differentiation and ASC surface marker expression. However, none of the post IORT samples yielded persistent outgrowth of bASC. CONCLUSIONS: After breast-conserving surgery, approximately 90% of local recurrences emerge in close proximity to the initial tumor bed, potentially reflecting a significant contribution of the tumor bed to relapse. Our data show that IORT, besides the proven effect on breast cancer cells, efficiently modifies the tumor environment by having an impact on tumor bed bASC. This effect on tumor bed stromal cells might contribute to reduce the risk of tumor relapse and metastases.

Long-term outcome after intraoperative radiotherapy as a boost in breast cancer.

PURPOSE: To investigate long-term oncological outcome and incidence of chronic side effects in patients with breast cancer and intraoperative radiotherapy given as an upfront boost (IORT boost). METHODS: Retrospective analysis of 400 patients with an IORT boost with low-energy X­rays (20 Gy), subsequent whole-breast irradiation (46-50 Gy), and annual oncological follow-up. Side effects were prospectively evaluated (LENT-SOMA scales) over a period of up to 15 years. Side effects scored ≥grade 2 at least three times during follow-up were judged to be chronic. RESULTS: The median age was 63 years (30-85) and the median follow-up was 78 months (2-180) after IORT boost. In 15 patients a local recurrence occurred, resulting in a local recurrence rate at 5, 10, and 15 years of 2.0%, 6.6%, and 10.1%, respectively. The overall survival rates at 5, 10, and 15 years were 92.1%, 81.8%, and 80.7%, respectively. The most common high-grade side effects were fibrosis (21%) and pain (8.6%). The majority of side effects occurred within the first 3 years. The actuarial rates of chronic fibrosis were 19.1% and 21.1% at 5 and ≥8 years, of chronic pain 8.6% at ≥4 years, of chronic edema of the breast 2.4% at ≥2 years, of chronic lymphedema 0.0% at 5 and 10 years, and of chronic hyperpigmentation 0.5% at ≥2 years. Side effects were similar or less than expected from an external beam boost. CONCLUSION: IORT boost appears to be a highly efficient and safe method for upfront delivery of the tumor bed boost in high-risk breast cancer patients.

Influence of Peripartum Expectations, Mode of Delivery, and Perineal Injury on Women's Postpartum Sexuality.

BACKGROUND: Sexual health has been identified as an important factor for postpartum quality of life. Although pregnancy-related changes in anatomy and metabolism return to their prepregnancy state, female sexual function may not be at the level it was before birth because of physical and psychological changes. AIM: The goal of our study was to explore the influence of the mode of delivery, perineal injury, and peripartum expectations on postpartum sexual function. METHODS: Between 2013 and 2018, 522 women were enrolled in this prospective investigation. At time of recruitment during the peripartum hospitalization, patients completed a standardized questionnaire addressing expectations concerning postpartum sexuality with focus on expected influence of the mode of delivery. Sexual function was evaluated using the Female Sexual Function Index (FSFI) and Sexual Activity Questionnaire (SAQ) at time of recruitment to evaluate baseline sexual function (4 weeks before pregnancy). Follow-up assessments were conducted at 3, 6, and 12 months postpartum. OUTCOMES: Peripartum expectations, influence of the mode of delivery, and perineal injury were analyzed for their impact on women's sexual function within 12 months postpartum by repetitive FSFI and SAQ assessments. RESULTS: A total of 522 women with 263 spontaneous vaginal deliveries, 41 operative vaginal deliveries, and 218 cesarean sections were analyzed. Although the data demonstrate a significant postpartum decline in sexual function at 3 and 6 months postpartum, sexual functioning converges to baseline prepregnancy values 12 months postpartum. This observation was independent of the mode of delivery and perineal injuries with no significant between-group differences at any of the analyzed time points. Apart from breastfeeding, for which negative anticipations resulted in impaired sexuality, women's expectations (pertaining to quantity and quality of female orgasm, partner's sexuality, fear of altered sexuality, frequency of intercourse, the mode of delivery) do not influence female sexual function at 12 months postpartum. CLINICAL IMPLICATIONS: Deciphering the potential influence of patient expectations as well as pregnancy- and childbirth-related aspects on female postpartum sexuality will help in the effort to improve women's postpartum sexual health. STRENGTHS & LIMITATIONS: As a strength of this study, postpartum sexuality was independently assessed with 2 different scoring systems (FSFI and SAQ). Limitations include that our follow-up is incomplete and amounts to about 2-thirds of patients who were initially recruited. CONCLUSION: The mode of delivery and perineal trauma do not influence women's postpartum sexual function. With the exception of breastfeeding, peripartum expectations do not result in altered sexual functioning at 12 months postpartum. Spaich S, Link G, Alvarez SO, et al. Influence of Peripartum Expectations, Mode of Delivery, and Perineal Injury on Women's Postpartum Sexuality. J Sex Med 2020;17:1312-1325.

Hemodynamic effects of intramyometrial epinephrine injection for blood loss reduction in laparoscopic myomectomy.

PURPOSE: To evaluate changes in hemodynamic effects of intramyometrial epinephrine injection for blood loss reduction in laparoscopic myomectomy. METHODS: A total of 185 women with symptomatic uterine fibroids who underwent laparoscopic myomectomy were enrolled in this study. Eighty-six women (study collective) received an intramyometrial injection of epinephrine and were compared to ninety-nine women (control collective) who underwent laparoscopic myomectomy without an intramyometrial epinephrine injection. Demographic parameters, change of hemodynamic parameters during surgery as well as hemoglobin drop after surgery were analyzed. RESULTS: In the study collective maximum systolic blood pressure (p < 0.001), maximum increase of the systolic blood pressure within 5 min (p = 0.003), duration of hypertension (p = 0.012), maximal (p < 0.001) and mean heart rate (p = 0.005), maximal increase of heart rate within 5 min (p = 0.003) and difference of mean to maximal heart rate (p < 0.001) were higher compared to the control collective. There was no difference in pre- and postoperative hemoglobin levels in both collectives and no intraoperative clinically relevant complication occurred due to intramyometrial epinephrine injection. CONCLUSION: The intramyometrial application of epinephrine seems to be safe but leads to significant alterations of hemodynamic parameters without a significant change in postoperative hemoglobin levels.

Evaluation of psychosocial and biological parameters in women seeking for a caesarean section and women who are aiming for vaginal delivery: a cross-sectional study.

PURPOSE: To investigate psychosocial and biological parameters that may influence decision-making concerning the mode of delivery in women with caesarean section on maternal request (CSMR). METHODS: Two hundred and two women were enrolled prospectively. The study sample (n = 93) consisted of women who aimed for CSMR, the control sample were women who seeked for vaginal delivery (n = 109). Parturients of both samples were enrolled during the pre-birth counselling at the delivery room at the University Medical Centre Mannheim, University Heidelberg, Germany. Women completed standardised questionnaires regarding psychosocial burden (SCL-R 90), fear of childbirth (W-DEQ) and anxiety (STAI), personality structure (HEXACO-Pi-R), and ambiguity tolerance (PFI, PNS, and NFC), social support (F-SozU) as well as one questionnaire assessing demographic parameters and further factors potentially influencing their choice of the mode of delivery. Hair cortisol concentration as a marker for chronic psychological stress and pressure pain threshold with a pressure algometer was assessed. RESULTS: Women in the CSMR sample had less social support (F-SozU: 2.99 ± 0.52 vs. 3.12 ± 0.32; p = 0.043) and were less educated (high school or university degree: 37 vs. 71%, p = 0.001) compared to parturients of the control sample. Women who underwent CSMR were less open-minded (HEXACO-Pi-R: 3.08 ± 0.57 vs. 3.26 ± 0.50; p = 0.016) and less extroverted (HEXACO-Pi-R: 3.34 ± 0.36 vs. 3.46 ± 0.41; p = 0.041). The control collective showed higher scores in negative appraisal of the birth ('W-DEQ-negative appraisal': 2.5 ± 0.8 vs. 2.2 ± 0.9; p = 0.006), whereas "lack of positive anticipation" was higher in the study collective ('W-DEQ-lack of positive anticipation': 3.2 ± 1.2 vs. 2.8 ± 0.8; p = 0.015). The study collective had higher pressure pain threshold values (5.07 ± 2.06 vs. 4.35 ± 1.38; p = 0.007), while no significant differences were observed in hair cortisol concentration comparing both groups (5.0 ± 11.4 vs. 4.9 ± 8.3; p = 0.426). The majority of the control collective (80%) had chosen the vaginal route as their mode of delivery before pregnancy, whereas only 21% of the women in the study collective decided to undergo CSMR before conception. The advice of social sources including both medical and non-medical aspects was rated less important in the study sample, with significant differences indicating a lower relevance of counsel from friends (p = 0.002) and midwives (p < 0.001). CONCLUSION: Women who inquired a CSMR had lower social support, were less educated, more anxious, and had a lower sensitivity for physical pain compared to women seeking for spontaneous delivery. This should be considered when counselling women requiring CSMR and could be leverage points to intervene to reduce the continuously increasing CSMR rate.

Sexual functioning after total versus subtotal laparoscopic hysterectomy.

AIM: To evaluate postoperative sexual functioning and the influence of patients' expectations on the change in sexuality following laparoscopic total (TLH) versus subtotal hysterectomy (LASH). METHODS: A total of 120 women undergoing laparoscopic hysterectomy were preoperatively enrolled in this bicentric prospective study. Sexual functioning (SF) was evaluated using the female sexual function index (FSFI). Additionally, participants filled in a standardised questionnaire concerning expected changes in SF after surgery. At 3, 6 and 12 months following surgery, women were asked again to assess their level of SF (FSFI). Data of women who participated in at least one FSFI follow-up assessment were analysed (n = 92). We compared the change in SF after surgery between patients with TLH (n = 46) and LASH (n = 46). Additionally, we calculated regression analyses with the patients' expectations as a predictor for change in FSFI scores. RESULTS: Comparing the change of FSFI scores after surgery in both collectives revealed differences only 3 months after surgery, as improvement was stronger for the LASH collective compared to the THL group (p = 0.006). There were no changes comparing collectives after 6 (p = 0.663) and 12 (p = 0.326) months. Concerning patients' expectations, for the LASH group baseline SF (p < 0.001), but not expectations (p = 0.567) predicted the strength of change at each of the follow ups: a lower level of baseline SF was linked to a stronger improvement after surgery. For the THL collective, both baseline SF (p < 0.001) as well as patients' expectations (3 months: p = 0.077, 6 months: p = 0.37, 12 months: p = 0.024) predicted the strength of change: both, a lower level of baseline SF and higher expectations towards an improvement predicted a stronger improvement. CONCLUSION: The preservation of the cervix does not show an advantage in improving SF after surgery. Both methods induce a comparable improvement in long-time SF, especially in patients with an impaired sexuality pre-surgery. Furthermore, patients' expectations concerning this matter seem to have an impact on the postoperative outcome; therefore, this circumstance should be considered in future projects.

Laparoscopic hysterectomy in the overweight and obese: does 3D imaging make a change?

PURPOSE: To evaluate the influence of three-dimensional (3D) high-definition (HD) visualisation in laparoscopic hysterectomy in normal weight, overweight and obese women. METHODS: A retrospective analysis of 180 patients undergoing total laparoscopic hysterectomy (TLH: n = 90) or laparoscopic supracervical hysterectomy (LASH: n = 90) was performed. The study collective consisted of 90 women (TLH: n = 45, LASH: n = 45), who underwent laparoscopic hysterectomy with a 3D HD laparoscopic system. Ninety matched (uterine weight, previous surgeries) women with hysterectomy (TLH: n = 45, LASH: n = 45) performed by the same surgeon with conventional two-dimensional laparoscopy formed the control group. Statistical analysis was accomplished stratifying patients according to body mass index (BMI) (≤24.9, 25-29.9, ≥30.0 kg/m2). In each BMI, collective subtypes of surgery (TLH, LASH) as well as hysterectomies as a whole were analysed. Demographic data and surgical parameters were evaluated. RESULTS: In all BMI subgroups, there were no significant differences concerning demographic parameters. Number of trocar site incisions needed was significantly less in women undergoing 3D compared to 2D laparoscopy independent of BMI. Furthermore, a significantly lower blood loss was revealed using 3D visualisation in LASH subgroups of the normal and overweight collectives. Three-dimensional laparoscopy was additionally associated with a significantly shorter duration of surgery in the TLH subgroup in overweight patients and a lower haemoglobin drop in the LASH subgroup of the obese. CONCLUSION: The need of less trocar site incisions concerning all weight groups as well.

Topic anaesthesia with a eutectic mixture of lidocaine/prilocaine cream after elective caesarean section: a randomised, placebo-controlled trial.

PURPOSE: Aim of the study was to investigate the topical application of a eutectic mixture of lidocaine/prilocaine (EMLA®) cream after caesarean section (CS) and its effect on postoperative pain, time to mobilisation, and time to discharge. MATERIALS AND METHODS: A total of 189 pregnant women were enrolled; full data sets were available for 139 of them, who were prospectively randomised to receive either placebo (control group) or EMLA® cream (study group) on the CS lesion directly as well as 24 h after surgery. Postoperative pain was assessed 24 and 48 h after surgery using the short form of the McGill Pain Questionnaire (SF-MPQ). Additional analgesic pain medication on demand was assessed in both groups. RESULTS: A total of 62 women were allocated randomly to the study and 77 patients to the control group before primary CS. There were no statistically significant differences regarding demographic and surgical parameters comparing both collectives. In addition, the postoperative total pain scores after 24 h [McGill total: 38.5 (0-102) vs. 50 (0-120) p = 0.0889] as well as after 48 h [24 (0-79) vs. 30.5 (0-92); p = 0.1455] showed no significant differences. Furthermore, time to mobilisation (hours) [9.68 (2.18-51.38) vs. 9.47 (4.18-41.77); p = 0.5919] and time to discharge (hours) [98.6 (54.08-170.15) vs. 98.2 (43.45-195.87); p = 0.5331] were comparable. CONCLUSION: The postoperative application of EMLA® cream after CS did not reduce postoperative pain or time to mobilisation or discharge, so that its use in this context has to be seen critically.

Postoperative sexual functioning in total versus subtotal laparoscopic hysterectomy: what do women expect?

PURPOSE: To evaluate sexual functioning and expected changes in sexual functioning in women with planned total versus subtotal laparoscopic hysterectomy. METHODS: A total of 120 women undergoing laparoscopic hysterectomy were preoperatively enrolled in this study with a cross-sectional design. Full data sets were available for 112 patients, so that 56 patients with planned total laparoscopic hysterectomy (TLH) and 56 women with planned laparoscopic supracervical hysterectomy (LASH) were preoperatively assessed. Sexual functioning was evaluated using the female sexual function index (FSFI). Additionally, participants filled in a standardised questionnaire concerning expected changes on sexual function after the procedure. Demographic parameters, expectations concerning postoperative sexuality and FSFI scores were analysed and compared in women undergoing TLH and LASH. RESULTS: There were no significant differences concerning demographic parameters and FSFI scores comparing collectives. Sexuality in general was considered more important in women undergoing LASH (2.88 ± 0.83 vs. 2.48 ± 0.89; p = 0.011). Also, in 29 patients (52%) opting for LASH and 8 (14%) patients undergoing TLH a potential change in postoperative sexuality had an impact on their choice for a subtotal/total hysterectomy, respectively (p < 0.001). CONCLUSION: Patients' expectations concerning preservation of the cervix and postoperative sexuality appear to have the potential to bias investigations comparing total with subtotal hysterectomy. Hence, future research focusing on this issue should be accomplished incorporating patients' expectations stratified by mode of intervention.

Elective Caesarean section on maternal request in Germany: factors affecting decision making concerning mode of delivery.

PURPOSE: To investigate sociopsychological factors of women undergoing a caesarean section on maternal request (CSMR). METHODS: Twenty-eight women who underwent CSMR and 29 women with vaginal delivery (VD) filled in standardized questionnaires concerning psychological burden (SCL-R 90), fear of childbirth (W-DEQ, STAI), personality structure (HEXACO-Pi-R) and social support (F-SozU) as well as one questionnaire assessing potential factors influencing their mode of delivery. RESULTS: Women with CSMR were older (36.5 ± 5.4 vs. 30.6 ± 5.2 years; p < 0.001) and suffered more from fear of childbirth (W-DEQ 4.3 ± 0.8 vs. 3.7 ± 1.2; p = 0.041), concerns for their child (W-DEQ 2.0 ± 1.5 vs. 1.3 ± 0.7; p = 0.026) and appraised the birth less negative (W-DEQ 2.0 ± 0.7 vs. 2.7 ± 1.1; p = 0.008). The majority of parturients had chosen their preferred mode of delivery before pregnancy (CS 61% vs. VD 82%, p = 0.328). In the decision-making process for the mode of delivery, the advice of the partner (85 and 90%) played an important role. 82% of the women who delivered via CSMR did not regret the decision for this mode of delivery. CONCLUSION: Women who underwent CS had higher fear of childbirth and appraised the birth less negative. The majority did not regret the decision for the CS and would even choose this mode of delivery for their next pregnancy. Although the partner and the physician seem to be important in the decision process for of the mode of delivery, reasons for the choice for CSMR appear to be multifactorial.

Dilatation or no dilatation of the cervix during cesarean section (Dondi Trial): a randomized controlled trial.

PURPOSE: To assess the effects of mechanical dilatation of the cervix during cesarean section on postoperative morbidity. METHODS: A total of 447 women with elective cesarean section were included in the Dondi trial (Dilatation or no dilatation of the cervix during cesarean section). The primary outcome measure of this randomized controlled trial was postpartum hemorrhage (PPH) within 6 weeks. Infectious morbidity (puerperal fever, endometritis, wound infection, and urinary tract infection), blood loss (need for blood transfusion or change in hemoglobin levels), and operating time were also evaluated. RESULTS: The rate of PPH within 6 weeks was not different between the two groups [dilatation group: 5 (2.4 %), no dilatation group: 3 (1.2 %), p = 0.479]. Infectious morbidity, blood loss, and operating time were not diverse as well. The only significant difference between the two groups was the rate of retained products of conception with fewer cases after cervical dilatation (0 versus 6.2 %, p < 0.001). CONCLUSIONS: Dilatation of the cervix during cesarean section compared with no dilatation of the cervix did not influence the risk of postpartum hemorrhage. However, there were fewer cases with retained products of conception after dilatation.

Topical anaesthetic patches for postoperative wound pain in laparoscopic gynaecological surgery: a prospective, blinded and randomised trial.

PURPOSE: Aim of this prospective study was to investigate the effectiveness of eutectic mixture of local anaesthetic (EMLA) patches on every abdominal incision for pain relief after gynaecologic laparoscopic surgery. METHODS: A total of 121 women were prospectively randomised to receive either placebo (control group) or EMLA (study group) patches on all abdominal incisions. Postoperative pain was assessed 24 and 48 h after surgery using the short form of the McGill Pain Questionnaire (SF-MPQ). The amount of analgesic pain medication on demand was assessed in both groups. RESULTS: Sixty women were allocated to the study group and 61 patients to the control group before laparoscopic surgery. There were no statistically significant differences regarding age, body mass index (BMI), duration of surgery and blood loss comparing both groups. There were no statistically significant differences between both groups with regard to postoperative total pain scores 24 h (McGill total score: 31.77 ± 27.95 vs. 36.80 ± 31.39, p = 0.3535) and 48 h (McGill total score: 19.18 ± 20.09 vs. 26.61 ± 27.70, p = 0.0942) after surgery. Time to mobilisation after surgery (hours) was significantly shorter in the study group (5.01 ± 3.72 vs. 5.78 ± 3.04, p = 0.0423). CONCLUSION: Despite of a significant reduction of time for mobilisation transdermal anaesthetic patches after gynaecologic laparoscopic surgery did not lead to decreased postoperative pain scores.

Bioelectrical impedance analysis in the assessment of pre-eclampsia.

PURPOSE: Aim of this prospective investigation was to assess pre-eclampsia by bioelectrical impedance analysis (BIA). METHODS: A total of 22 pre-eclamptic as well as matched (patients' age, gestational age, parity, gravidity) healthy pregnant women underwent whole body BIA on admission and then, pre-eclamptic patients, every 2 days until childbirth. For all measured BIA single values and their corresponding reference value mean, standard deviation, minimum and maximum were calculated to compare pre-eclamptic women with corresponding reference values. Furthermore a paired t test and an ANOVA of repeated measurements were performed to detect differences of intraindividual measurements. Subsequently an analysis of variance was accomplished to analyse general changes in the course of time of investigated patients, who were measured more than once. RESULTS: Except for the phase angle, BIA parameters of pre-eclamptic women compared to corresponding reference values were significantly different, suggesting an increase of total body water in pre-eclampsia. Repeated measurements did not reveal statistically significant intra- or interindividual differences in the course of time. CONCLUSION: Bioelectrical impedance analysis allows differentiating healthy from pre-eclamptic women. Further investigations are needed to analyse if BIA is capable to serve as a prognostic diagnostic tool in the detection of deterioration of pre-eclampsia.