Surgical staging and prognosis in serous borderline ovarian tumours (BOT): a subanalysis of the AGO ROBOT study.

BACKGROUND: Incomplete surgical staging is a negative prognostic factor for patients with borderline ovarian tumours (BOT). However, little is known about the prognostic impact of each individual staging procedure. METHODS: Clinical parameters of 950 patients with BOT (confirmed by central reference pathology) treated between 1998 and 2008 at 24 German AGO centres were analysed. In 559 patients with serous BOT and adequate ovarian surgery, further recommended staging procedures (omentectomy, peritoneal biopsies, cytology) were evaluated applying Cox regression models with respect to progression-free survival (PFS). RESULTS: For patients with one missing staging procedure, the hazard ratio (HR) for recurrence was 1.25 (95%-CI 0.66-2.39; P=0.497). This risk increased with each additional procedure skipped reaching statistical significance in case of two (HR 1.95; 95%-CI 1.06-3.58; P=0.031) and three missing steps (HR 2.37; 95%-CI 1.22-4.64; P=0.011). The most crucial procedure was omentectomy which retained a statistically significant impact on PFS in multiple analysis (HR 1.91; 95%-CI 1.15-3.19; P=0.013) adjusting for previously established prognostic factors as FIGO stage, tumour residuals, and fertility preservation. CONCLUSION: Individual surgical staging procedures contribute to the prognosis for patients with serous BOT. In this analysis, recurrence risk increased with each skipped surgical step. This should be considered when re-staging procedures following incomplete primary surgery are discussed.

A lecture program on complementary and alternative medicine for cancer patients--evaluation of the pilot phase.

About half of all patients with cancer use complementary or alternative medicine (CAM). In 2013, we started a lecture program for patients, followed by evidence-based recommendations on counseling on CAM. These recommendations have been published before by this working group. The aim of the program is to provide scientific facts on the most often used CAM methods in standardized presentations which help patients discuss the topic with their oncologists and support shared decision making. The article presents the evaluation of the pilot phase. Participants received a standardized questionnaire before the start of the lecture. The questionnaire comprises four parts: demographic data, data concerning experience with CAM, satisfaction with the lecture, and needs for further information on CAM. In 2013, seven lectures on CAM were given in cooperation with regional branches of the German Cancer Society in several German states. Four hundred sixty patients and relatives took part (75% females and 16% males). Forty-eight percent formerly had used CAM. Most often named sources of information on CAM were print media (48%) and the Internet (37%). Most participants rated additional written information valuable. About one third would like to have an individual consultation concerning CAM. A standardized presentation of evidence on CAM methods most often used, together with recommendations on the self-management of symptoms, is highly appreciated. The concept of a highly interactive lecture comprising is feasible and if presented in lay terminology, adequate. In order to give additional support on the topic, written information should be provided as the first step.

Attitudes of members of the German Society for Palliative Medicine toward complementary and alternative medicine for cancer patients.

BACKGROUND: A high proportion of cancer patients use complementary and alternative medicine (CAM). In oncology, risks of CAM are side effects and interactions. OBJECTIVE: Our aim was to conduct a survey on professionals in palliative care regarding attitudes toward CAM. DESIGN AND SUBJECTS: An internet-based survey with a standardized questionnaire was sent to all members of the German Society for Palliative Care. MEASUREMENTS: The questionnaire collected data on attitude toward CAM and experiences. RESULTS: Six hundred and ninety questionnaires (19 %) were returned (49 % physicians, 35 % nurses, 3 % psychologists). Acceptance of CAM is high (92 % for complementary and 54 % for alternative medicine). Most participants had already been asked on CAM by patients (95 %) and relatives (89 %). Forty-four percent already had used complementary methods and 5 % alternative methods. Only 21 % think themselves adequately informed. Seventy-four percent would use complementary methods in a patient with advanced tumor, and 62 % would use alternative therapy in patients if there was no other therapy. Even from those who are skeptical 45 % would treat a patient with alternative methods. CONCLUSIONS: In order to inform patients on CAM and to further patients' autonomy, evidence on benefits and harms of CAM must be provided. As awareness of risks from CAM is low and critical appraisal especially of alternative medicine missing, but interest on information on CAM is high, experts should provide evidence-based recommendations for CAM in palliative care to members of different professions. This could be done by a curriculum focusing on the most often used CAM methods.

Age-dependent differences in borderline ovarian tumours (BOT) regarding clinical characteristics and outcome: results from a sub-analysis of the Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) ROBOT study.

BACKGROUND: Approximately one-third of all borderline ovarian tumours (BOT) are diagnosed in patients with child-bearing potential. Detailed information regarding their specific characteristics and prognostic factors is limited. METHODS: Clinical parameters of BOT patients treated between 1998 and 2008 in 24 German centres were retrospectively investigated. Central pathology review and prospective follow-up were carried out. Patients <40 versus ≥40 years were analysed separately and then compared regarding clinico-pathological variables and prognosis. RESULTS: A total of 950 BOT patients with a median age of 49.1 (14.1-91.5) years were analysed [280 patients <40 years (29.5%), 670 patients ≥40 years (70.5%)]. Fertility-preserving surgery was carried out in 53.2% (149 of 280) of patients <40 years with preservation of the primarily affected ovary in 32 of these 149 cases (21.5%). Recurrence was significantly more frequent in patients <40 years (19.0% versus 10.1% 5-year recurrence rate, P < 0.001), usually in ovarian tissue, whereas disease-specific overall survival did not differ between the subgroups. In case of recurrent disease, malignant transformation was less frequent in younger than in older patients (12.0% versus 66.7%, P < 0.001), mostly presenting as invasive peritoneal carcinomatosis. Multivariate analysis for patients <40 years identified advanced International Federation of Gynecology and Obstetrics (FIGO) stage and fertility-sparing approach as independent prognostic factors negatively affecting progression-free survival (PFS) while, for patients ≥40 years, higher FIGO stage and incomplete staging was associated with impaired PFS. CONCLUSIONS: Despite favourable survival, young BOT patients with child-bearing potential are at higher risk for disease recurrence. However, relapses usually remain BOT in the preserved ovaries as opposed to older patients being at higher risk for malignant transformation in peritoneal or distant localisation. Therefore, fertility-sparing approach can be justified for younger patients after thorough consultation.

Integrating cancer patients' perspectives into treatment decisions and treatment evaluation using patient-reported outcomes--a concept paper.

Patient-reported outcomes are an important tool in clinical research. In the setting of cancer treatments, benefit of therapy is essentially characterised by improvement of survival as well as quality of life (QoL). A standardised instrument to assess QoL is the standardised QoL questionnaire of the European Organisation for Research and Treatment (EORTC QLQ-C30 questionnaire). QoL instruments provide data on different aspects (domains) of the framework of QoL. Using these questionnaires in studies provides data on how a treatment affects QoL in a group of patients. The goal of our concept is to individualise QoL and to use validated instruments in order to integrate patients' perspectives and aims into treatment assessment, planning and control. We propose to use the domains of the EORTC QLQ-C30 and to ask the patient to determine which objectives besides survival are relevant for him and should be achieved by treatment. These individual goals can be used in a process of shared decision-making to choose and monitor treatment. In clinical studies, this approach would allow to recruit more patients who would most probably benefit from the therapy. In addition, supportive data could be gathered in correlation to treatment goals and actual benefits.

Attitude of employees of a university clinic to complementary and alternative medicine in oncology.

BACKGROUND: Cancer patients often use complementary and alternative medicine (CAM), yet discussion with the oncologist is often missing and oncologists lack knowledge in CAM. PATIENTS AND METHODS: In order to learn more about the attitude of professionals in oncology toward CAM, a survey was conducted on employees of a German university clinic using a structured questionnaire. RESULTS: In total, 547 employees took part in the survey. One-third would definitely use CAM on cancer patients. Female employees are more interested in CAM than males (80% versus 20%; P = 0.001); physicians are less interested than nurses (57% versus 72%; P = 0.008). 2.5% of physicians and 9% of nurses are convinced that CAM is as effective as conventional therapy in cancer. Fifty-two percent of physicians and 12% of nurses agree that adverse effects due to CAM may be possible. Seventy-three percent did not consider themselves adequately informed on CAM for their professional work. CONCLUSIONS: As a substantial part of participants would use CAM on cancer patients and most are interested in but not trained on this topic, there is a need for training of professionals from different professions working in oncology.

Counseling cancer patients on complementary and alternative medicine. Background, theory, and implementation of nationwide counseling facilities.

BACKGROUND AND PURPOSE: Complementary and alternative medicine (CAM) is of high relevance in oncology. Only a minority of professionals feel competent in CAM. Our aim was to provide a strategy for establishing evidence-based counseling on CAM in oncology in the German health system. METHODS: We performed a systematic search of the literature on patient counseling concerning CAM. Of 811 articles identified in this search 51 met our inclusion criteria. Data from these articles were analyzed and adapted to the needs of German patients by a group of experts of the DEGRO ("Deutschen Gesellschaft für Radioonkologie") and the German Cancer Society. In the next step a strategy about how to integrate evidence-based counseling on CAM at cancer centers and oncological institutions was developed. RESULTS: First, evidence-based recommendations on CAM counseling were derived. The core of our strategy combines two levels of information provision: level 1 will be oncologists, radiotherapists and other specialists and level 2 oncological CAM experts. The latter group will serve as trainers and backup for complicated or advanced questions and for individual counseling of patients with complex needs. Professionals in level 1 will be offered special training. CONCLUSION: Evidence-based counseling on CAM is not only possible but also mandatory in order to meet patient information needs. Our proposal would allow for integrated counseling available at all oncological institutions and guarantee a high quality. Furthermore, provision of information on two different levels allows the effective use of resources (manpower and financing).

Potential interactions of complementary and alternative medicine with cancer therapy in outpatients with gynecological cancer in a comprehensive cancer center.

PURPOSE: About 40-50 % of cancer patients use complementary and alternative medicine (CAM). Women, and especially those with gynecological cancers, are more active in this field than men. The goal of our study was to estimate the likelihood of CAM use and the likelihood of interactions of CAM with cancer therapy in the setting of a gynecological outpatient clinic at a German Comprehensive Cancer Center (CCC). METHODS: One hundred consecutive gynecological outdoor patients of the CCC in Frankfurt am Main in Germany were interviewed with a standardized questionnaire on CAM use. An investigation on potential interactions was done by matching a scientific database systematically. RESULTS: Sixty-nine of the interviewed 100 women received chemotherapy, 23 endocrine therapy and 41 monoclonal antibodies. In total, 64 % used CAM, 48 % used at least one substance-bound CAM. In 17 out of those 48 cases (35 %), interactions were unlikely, whereas they were probable in 14 patients (29 %). Thus, a third of all patients in this study were in danger of interactions. More than half of all CAM users and three quarters of users of substance-bound CAM are at risk of interactions. This number is independent of whether the patient is taking chemotherapy, endocrine therapy or antibodies. CONCLUSIONS: The frequency of CAM use we found is in line with international data from CCCs in the USA. To our knowledge, this is the first study publishing data on the frequency of potential interactions. Thus, an initiative to protect women from the dangers of uncontrolled CAM use is urgently needed. In the discussion, we propose a concept of how to achieve this aim.

A new variable-view rigid endoscope evaluated in advanced gynecologic laparoscopy: a pilot study.

BACKGROUND: This pilot study aimed to evaluate the optical performance and clinical handling of a new variable-view rigid endoscope with angulation from 0 º to 120 º in gynecologic laparoscopic surgery. METHODS: The EndoCAMeleon endoscope was assessed by experienced surgeons and assistants during a variety of advanced gynecologic laparoscopic procedures. After each procedure, both the surgeon and the assistant each completed questionnaires designed to assess the endoscope's ease of handling and optical performance. RESULTS: The endoscope was assessed during 21 advanced procedures. Questionnaire responses confirmed surgeon and assistant satisfaction with the mechanical handling and vision provided by the endoscope. In particular, the ability to vary the viewing angles enabled the surgeon to visualize the surgical site without moving the endoscope shaft. CONCLUSIONS: The new endoscope performed well in the hands of experienced surgeons and assistants undertaking advanced procedures. The variable-view rigid endoscope allows the use of visual ports during primary port entry and enhances vision. Further study is required to evaluate its performance in routine practice.

Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.

OBJECTIVE: Intra-abdominal adhesion formation after abdominal surgery is the most common postsurgical complication, and the consequences are a considerable burden for patients, surgeons and health systems. Since a wide variety of factors influence adhesion formation, it is difficult to define clear guidelines on how to reduce adhesion formation in daily practice. Given this dilemma, this study assessed the awareness and perception of adhesion formation among gynaecologists in Germany in order to define a baseline for further research and education. STUDY DESIGN: The Clinical Adhesion Research and Evaluation (CARE) group of the University of Giessen designed a questionnaire that was sent to the heads of all gynaecological departments in Germany. The director or one of the surgical consultants was asked to complete the questionnaire and return it for evaluation. RESULTS: The completed questionnaire was returned by 279 of 833 gynaecological departments. Interviewed surgeons expected adhesions to form in 15% of cases after laparoscopy and 40% after laparotomy. Before surgery, 83.1% of the respondents told their patients about the risk of prior adhesion formation. More than 60% believed that postsurgical adhesion accounts for major morbidity. Infections within the abdomen, previous surgery and extensive tissue trauma were thought to have the most influence on adhesion formation. Risk of adhesion formation was thought to be highest in endometriosis and adhesiolysis surgery. The respondents agreed on performing adhesiolysis in symptomatic but not in all patients. Only 38.4% used adhesion reduction agents regularly. A total of 65.1% of a repertoire of adhesion prevention agents were familiar to the interviewed surgeons. Only 22.0% of them used anti-adhesion products in clinical practice. In general, the respondents were uncertain whether these products play an important role in adhesion reduction, represented by a range of 1.97+/-0.98% on a scale from 0 to 4. CONCLUSIONS: Even though postoperative adhesions are recognized as a major cause for morbidity, and it is widely agreed that infections, extensive tissue trauma and surgery lead to adhesion formation, there is uncertainty about the treatment and prophylactic strategies for dealing with adhesions. This dilemma reflects the awareness and perception of gynaecologists in Germany and is an initial point for further research.

Uterine surgery in postpartum hemorrhage.

Uterine atony accounts for the majority of primary postpartum hemorrhage. Timely recognition and intervention are fundamental in preventing serious maternal morbidity and mortality. Combinations of conservative manual and medical therapies are adequate and successful treatment options in most cases. However, when the hemorrhagic process continues and when either clotting abnormalities or hemodynamic instability develop, the next step must be an invasive intervention. Depending on the mode of delivery a vaginal approach (i.e. curettage and uterine packing) after spontaneous delivery or an abdominal surgical approach (i.e. compression sutures and systematic devascularization) after a Cesarean delivery can be performed. Uterine compression sutures are especially highly effective and a straightforward and easy emergency procedure which conserves fertility. The ultima ratio in all cases of persistent haemorrhage after conservative and uterus preserving surgical therapy is the emergent hysterectomy. It might be of advantage to perform a subtotal or supracervical hysterectomy compared to a total hysterectomy in an emergency setting.

Surgery for recurrent ovarian cancer: role of peritoneal carcinomatosis: exploratory analysis of the DESKTOP I Trial about risk factors, surgical implications, and prognostic value of peritoneal carcinomatosis.

BACKGROUND: Almost all retrospective trials pointed out that a benefit of surgery for recurrent ovarian cancer may be limited to patients in whom a macroscopic complete resection could be achieved. Peritoneal carcinomatosis has been reported to be either a negative predictor for resectability or a negative prognostic factor, or both. The role of peritoneal carcinomatosis in a multicenter trial was investigated. METHODS: Exploratory analysis of the DESKTOP I trial (multicenter trial of patients undergoing surgery for recurrent ovarian cancer, 2000 to 2003). RESULTS: A total of 125 patients (50%) who underwent surgery for recurrent ovarian cancer had peritoneal carcinomatosis. Univariate analyses showed worse overall survival for patients with peritoneal carcinomatosis compared with patients without carcinomatosis (P < .0001). Patients with and without peritoneal carcinomatosis had a complete resection rate of 26% and 74%, respectively (P < .0001). This corresponded with the observation that patients with complete resection had a better prognosis than those with minimal residual disease of 1 to 5 mm, which commonly reflects peritoneal carcinomatosis (P = .0002). However, patients who underwent complete resection, despite peritoneal carcinomatosis, had a 2-year survival rate of 77%, which was similar to the 2-year survival rate of patients with completely debulked disease who did not have peritoneal carcinomatosis (81%) (P = .96). Analysis of prognostic factors did not show any independent effect of peritoneal carcinomatosis on survival in patients who underwent complete resection. CONCLUSIONS: Peritoneal carcinomatosis was a negative predictor for complete resection but had no effect on prognosis if complete resection could be achieved. Improving surgical skills might be one step to increase the proportion of patients who might benefit from surgery for recurrent disease.

Uterine compression U-sutures in primary postpartum hemorrhage after Cesarean section: fertility preservation with a simple and effective technique.

BACKGROUND: Transmural uterine compression suturing methods are a fertility-preserving alternative in patients with atonic primary postpartum hemorrhage (PPPH), which does not respond to manual compression or drugs. This study evaluated the effectiveness of a modified U-suturing technique in effecting uterine compression in patients with PPPH after Cesarean section. METHODS: U-suture uterine compression was introduced at our hospital at the beginning of 2005. The medical records of patients with PPPH after Cesarean section who had undergone this treatment, and results of a follow-up and questionnaire were evaluated and our experience with this method was reviewed. RESULTS: Between January 2005 and September 2007, seven patients underwent uterine compression with U-sutures after PPPH. In all cases, treatment was successful, the hemorrhage was controlled and the uterus preserved. Normal menstruation patterns returned in the five patients who returned the questionnaire and no surgery related morbidities were noted at the follow-up examinations of six patients. The technique was simple to perform in an emergency situation. CONCLUSIONS: Uterine compression with U-sutures is a highly effective and straightforward emergency procedure which conserves the uterus in these patients.