With the adoption of the Cancer Screening and Registration Law (KFRG, 2013) based on the National Cancer Plan, the so far opportunistic cervical cancer screening in Germany is to be converted to an ...organized screening program. This decision in Germany is consistent with the new EU Guidelines and, in anticipation of the upcoming German S3 guideline for cervical cancer screening.
To show noninferiority of a limited-excision (resection of the dysplastic lesion only) vs. classical Large Loop Excision of the Transformation Zone (LLETZ).
In this prospective, randomized, ...multicenter trial, women with human papillomavirus (HPV) positive cervical intraepithelial neoplasia grade 3 were randomized into two groups (1:1). Primary outcome was the rate of negative HPV tests after 6 months, secondary outcomes included cone size, complete resection rates as well as cytological and histological results after 6 and 12 months. A sample size of 1,000 was calculated to show noninferiority of the limited-excision compared to the LLETZ group using a noninferiority margin of 5%. Enrollment was stopped after 100 patients due to slow accrual.
Patients in the limited-excision group did not show a lower number of negative HPV tests (78% LLETZ-80% limited-excision=-2%; 90% confidence interval=-15%, 12%). The limited-excision resulted in a substantially lower cone size (LLETZ: 1.97 mL vs. limited-excision: 1.02 mL; p<0.001) but higher numbers of involved margins (LLETZ: 8% vs. limited-excision: 20%). Although postoperative cytological results slightly differed, histological results were similar in both groups. One limited-excision patient received immediate re-conisation, whereas one patient in each group was scheduled for re-conisation after 6 months.
The limited-excision could represent a promising option to reduce the surgical extent of conisations while maintaining oncological safety. The trial was not sufficiently powered to reach statistical significance due to early termination. Nevertheless, the study provides important insights in the feasibility of a limited-excision and could serve as a pilot study for future trials.
German Clinical Trials Register Identifier: DRKS00006169.
Physical training is recommended in various national and international guidelines for patients with cancer. Observational studies have shown that physical activity leads to reduced recurrence and ...mortality rates by 20-40% in colorectal, breast, and prostate cancer. Despite existing evidence, a systematic care structure is still lacking. The primary aim of this study is to implement and evaluate an online training platform to strengthen physical performance and patient empowerment after cancer surgery.
The evaluation will be conducted as a prospective multicenter randomized controlled trial with three subgroups (colorectal-, breast-, and prostate cancer). Each group will include 100 patients (total 300 patients including dropouts; clinical stages T1-3 and/or N+; M0 after surgery intervention) and the primary endpoint (13% increase in the maximal oxygen consumption during exercise) will be examined. The intervention group will receive a 6-month home-based online training (2-3 times per week strength-endurance training using video presentations), bidirectional activity feedback information, online communication, and online counseling. The control group (usual care) will be advised lifestyle improvement. In-hospital testing will be performed before, during, and after the intervention. In addition to cardiopulmonary capacity, tumor specific diagnostics (liquid biopsy, depression and fatigue assessment, metabolic and endothelial screening) will be applied.
Due to the increasing incidence of cancer, associated with considerable mortality, morbidity and impaired quality of life, there is an imperative requirement for improved cancer care, of which structured physical training may become an integral component.
DRKS-ID: DRKS00020499 ; Registered 17 March 2020.
Objective Photodynamic therapy has the potential of a minimal invasive outpatient procedure for CIN patients at reproductive ages. The purpose of this study was to examine the pharmacokinetics and ...selectivity of porphyrin synthesis after topical application of hexaminolevulinate (HAL) in patients with cervical intraepithelial neoplasia (CIN). Study Design Twenty-four women with CIN 1-3 received 4 mmol/L or 10 mmol/L HAL dissolved in thermolabile pluronic F 127 gel topically 5-720 minutes before surgical conization. The microscopic fluorescence pattern was quantified by ex vivo fluorescence spectroscopy at a wavelength of 635 nm and semiquantitatively by digital image analysis from cryosections. Results With 4 and 10 mmol/L HAL, porphyrin fluorescence intensity increased over time, reaching a peak after 180-540 minutes application intervals in CIN and normal epithelium. However, the peak was much more pronounced in CIN than in normal tissues. The fluorescence intensity with 10 mmol/L was significantly higher than that with 4 mmol/L in CIN tissues ( P < .05). Maximum intensity could generally be detected in the lower layer of the epithelium. Conclusion HAL seems to be a promising molecule for fluorescence diagnosis. For further treatment studies, we recommend application of 10 mmol/L HAL 300-540 minutes before photodynamic therapy in CIN.
Objective. The relation of lunar phases to the birth rate has been the focus of considerable research with still controversial results. The purpose of this study was to examine the influence of the ...lunar cycle on the frequency of birth, on instrumental delivery, neonatal outcome as well as a possible relationship between lunar position at time of conception and the gender of the child. Material and methods. Six thousand seven hundred and twenty five deliveries were retrospectively analyzed from 01 January 2000 to 31 December 2006 at the Department of Obstetrics and Gynaecology of the University Medical School of Hannover. Inclusion criteria were: spontaneous vaginal births without induction, vacuum and forceps extractions as well as non-elective cesarean sections, all cases without labor induction. Exact lunar phases were determined by means of birthday and birth time by a specific computer software. Results. The analysis revealed no significant correlation of birth rate to lunar phases. There were also no significant differences regarding birth complications, neonatal outcome and gender to the lunar cycle at the time of conception. Conclusion. There is no predictable influence of the lunar cycle on deliveries or delivery complications nor to the gender of the baby. As expected and in agreement with some recent studies this pervasive myth is not evidence based.
Causation and causal inference are of utmost importance in obstetrics and gynecology. In many clinical situations, causal reasoning is involved in etiological explanations, diagnostic considerations, ...and conversations about prognosis. In this paper, we offer an overview of the philosophical accounts of causation that may not be familiar to, but still be appreciated by, the busy clinician. In our discussion, we do not try to simplify what is a rather complex range of ideas. We begin with an introduction to some important basic ideas, followed by 2 sections on the metaphysical and epistemological aspects of causality, which offer a more detailed discussion of some of its specific philosophical facets, using examples from obstetrical and gynecologic research and practice along the way. We hope our discussion will help deepen the thinking and discourse about causation and causal inference in gynecology and obstetrics.
A total of 2,546,325 breast cancer survivors are estimated to live in the United States. The organized breast cancer follow-up programs do not generally include breast ultrasound in asymptomatic ...women. The purpose of our prospective study was to investigate the efficacy of breast ultrasound in detecting previously occult recurrences. A total of 735 eligible patients with a history of breast cancer were recruited. We assessed the same patient population before (routine follow-up program) and after (study follow-up program) the introduction of an additional ultrasound examination. In the routine follow-up program 245 of 735 patients (33.3% 95% confidence-interval (CI): 29.9-36.7) had an ultrasound due to abnormal local or mammographic findings. 490 of 735 patients (66.7% 95% CI: 63.3-70.1) were initially considered asymptomatic and received an additional ultrasound exclusively within the study follow-up program. All positive examination results were followed by accelerated core needle biopsy. The routine follow-up program led to a biopsy in 66 of 735 patients (9.0%) revealing a recurrent cancer in 27 cases (3.7%). The study follow-up program with the additional ultrasound led to another 21 biopsies raising the total number of patients who had to undergo a biopsy from 9.0% (95% CI: 6.9-11.1) to 11.8% (95% CI: 9.5-14.2). Finally, we diagnosed a previously occult malignant lesion in an additional six patients following this protocol. Therefore, the rate of detected recurrences rose from 3.7% (95% CI: 2.3-5.0) in the routine follow-up program to 4.5% (95% CI: 3.0-6.0) in the study follow-up program (p = 0.041). Negative side effects were the additional costs (the costs per detected malignancy in the routine follow-up program were $2455.69; the costs for each additionally detected malignancy in the study follow-up program were $7580.30), the higher overall biopsy rate (9.0 vs. 11.8%) and the elevated benign biopsies rate (59.1% vs. 71.4%). Regarding these results, the advantages and disadvantages of additional breast ultrasound must be discussed for every follow-up patient individually even today, as we can detect a significantly higher number of previously occult malignancies.
Systematic pelvic and paraaortic lymphadenectomy has been widely used in the surgical treatment of patients with advanced ovarian cancer, although supporting evidence from randomized clinical trials ...has been limited.
We intraoperatively randomly assigned patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy. All centers had to qualify with regard to surgical skills before participation in the trial. The primary end point was overall survival.
A total of 647 patients underwent randomization from December 2008 through January 2012, were assigned to undergo lymphadenectomy (323 patients) or not undergo lymphadenectomy (324), and were included in the analysis. Among patients who underwent lymphadenectomy, the median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes). The median overall survival was 69.2 months in the no-lymphadenectomy group and 65.5 months in the lymphadenectomy group (hazard ratio for death in the lymphadenectomy group, 1.06; 95% confidence interval CI, 0.83 to 1.34; P = 0.65), and median progression-free survival was 25.5 months in both groups (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P = 0.29). Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% P = 0.01; mortality within 60 days after surgery, 3.1% vs. 0.9% P = 0.049).
Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression-free survival than no lymphadenectomy and was associated with a higher incidence of postoperative complications. (Funded by Deutsche Forschungsgemeinschaft and the Austrian Science Fund; LION ClinicalTrials.gov number, NCT00712218.).
Zusammenfassung
Hintergrund
Gemäß dem Beschluss des Gemeinsamen Bundesausschusses (G-BA) erfolgt die Früherkennungsuntersuchung auf Gebärmutterhalskrebs ab 2020 als organisiertes Vorsorgeprogramm mit ...Einladungsmodell. Dies bietet Chancen für eine sozial ausgewogenere Inanspruchnahme.
Material und Methode
Es erfolgte eine Auswertung der relevanten Literatur.
Ergebnisse
Das Programm der Zervixkarzinom-Vorsorge ab 2020 sieht vor, dass die Krankenkassen anspruchsberechtigte Frauen im Alter zwischen 20 und 65 Jahren alle 5 Jahre zur Untersuchung einladen. Diese Frauen können auch ohne Einladung zum Screening gehen. Eine Altersobergrenze für die Früherkennungsuntersuchung auf Gebärmutterhalskrebs besteht nicht. Im Alter von 20–34 Jahren erfolgt wie bisher eine jährliche zytologische Untersuchung (Pap-Abstrich). Neu ist, dass Frauen ab 35 Jahren alle 3 Jahre Anspruch auf ein kombiniertes Screening aus zytologischer Untersuchung und HPV-Test haben (Kotest). Der Test auf HPV (humanes Papillomvirus) detektiert CIN 3 (zervikale intraepitheliale Neoplasien Grad 3) besser als die Zytologie, sodass das Screeningintervall von jährlich auf 3‑jährlich verlängert wurde. Bei auffälligen Befunden kann laut Richtlinie für organisierte Krebsfrüherkennungsprogramme der Kotest wiederholt werden oder eine Abklärungskolposkopie erfolgen. Diese neue Leistung umfasst u. a. die Untersuchung mit Kolposkop, ggf. eine Biopsie und Kürettage sowie die Beratung der Versicherten.
Schlussfolgerung
Aufgrund der akkumulierten und in der S3-Leitlinie zur Prävention des Zervixkarzinoms bewerteten Evidenz wurde die Krebsvorsorge in Deutschland weiterentwickelt. Dazu gehört ein doppelter Paradigmenwechsel in der sekundären Prävention mit Einführung des molekularen Nachweises auf HPV und des organisierten Screenings.
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