Intraoperative and postoperative complications of gynecological laparoscopic interventions: incidence and risk factors.

PURPOSE: The aims of this study were to determine the incidence of intraoperative and postoperative complications of laparoscopic gynecological interventions and to identify risk factors for such complications. METHODS: All patients who underwent laparoscopic interventions from September 2013 to September 2017 at the Department of Gynecology, Obstetrics and Reproductive Medicine, Saarland University Hospital were identified retrospectively using a prospectively compiled clinical database. Binary logistic regression analysis was used to identify independent risk factors for intra- and postoperative complications. RESULTS: Data from 3351 patients were included in the final analysis. Overall, 188 (5.6%) intraoperative and 219 (6.5%) postoperative complications were detected. On multivariate analysis, age [odds ratio (OR), 1.03; 95% confidence interval (CI) 1.01-1.04], surgery duration (OR, 1.02; 95% CI 1.02-1.03), carbon dioxide use (OR, 0.99; 95% CI 0.99-1.00), and surgical indication (all p ≤ 0.01) were independent risk factors for intraoperative and duration of surgery (OR, 1.01; 95% CI 1.01-1.02; p ≤ 0.01), carbon dioxide use (OR, 0.99; 95% CI 0.99-1.00; p ≤ 0.01), hemoglobin drop (OR, 1.41; 95% CI 1.21-1.65; p ≤ 0.01), and ASA status (p = 0.04) for postoperative complications. CONCLUSION: In this large retrospective analysis with a generally low incidence of complications (5.6% intraoperative and 6.5% postoperative complications), a representative risk collective was identified: Patients aged > 38 years, surgery duration > 99 min, benign or malignant adnex findings were at higher risk for intraoperative and patients with surgery duration > 94 min, hemoglobin drop > 2 g/dl and ASA status III at higher risk for postoperative complications.

Survey of current practices and opinions of German Society of Gynecologic Endoscopy members regarding the treatment of ovarian neoplasia by robotic surgery.

PURPOSE: As data on this topic are sparse and contradictory, we aimed to ascertain the opinions of the members of the German Society of Gynecologic Endoscopy (AGE) regarding the use of robotic surgery in the treatment of ovarian malignancies. METHODS: In 2015, an anonymous questionnaire was sent to AGE members to assess their views on the treatment of ovarian malignancies by robotic surgery according to T stage and the current treatment practices in their facilities. RESULTS: Of the 228 respondents, 132 (58%) were fellows or attending physicians and 156 (68%) worked at university hospitals or tertiary referral centers. Most [n = 218 (96%)] respondents reported treating < 10% of their patients using robotic surgery. Respondents felt that T1 and borderline ovarian tumors, but not T2 (51%) or T3/4 (76%) tumors, should and could be treated by robot surgery. 162 (71%) respondents considered the currently available data on this subject to be insufficient, and 42% indicated their willingness to participate in clinical studies on the applicability of robotic surgery to the treatment of T1/2 ovarian tumors. CONCLUSION: The majority of AGE members surveyed considered robotic surgery to be an option for the treatment of T1 ovarian malignancies and borderline ovarian tumors. However, prospective randomized studies are needed to determine the relevance of robotic surgery in this context.

The impact of acute radiation morbidity on therapeutic outcome.

BACKGROUND: The acute radiation morbidity is associated with the radiation therapy outcome. METHODS: To give a summary of the impact of acute radiation morbidity on therapeutic outcome. RESULTS: Excessive acute side effects, most often seen in accelerated or hyperfractionated protocols or in combined radiochemotherapy may lead to interruptions of the radiation cycle and consecutively decreased tumor control rates. They may also result in an increase of consequential late damages. Furtheron, the patient may feel serious discomfort by subjective or objective complaints. CONCLUSIONS: Further national and international efforts have to be performed to lower the acute radiation related morbidity and to increase the effectiveness of radiation treatment.

Variability of individual normal tissue radiation sensitivity. An international empirical evaluation of endogenous and exogenous response modifiers.

BACKGROUND: The variability of normal-tissue response is of major concern for radiation therapy. Multiple endogenous and exogenous factors are qualitatively known to alter the acute and late tissue response. Which of them are regarded most important by the European radiation oncologists and what is, empirically, their quantitative influence on the acute or late tissue tolerance? METHODS: In August 1997, we sent a questionnaire to 255 European radiation oncology departments. Among others, the questionnaire asked for endogenous and exogenous factors modifying the tissue response to radiation therapy and their quantitative influence on the acute and late radiation morbidity (TD 5/5). Fifty-five questionnaires (21.5%) were answered. RESULTS: Empirically, the most important endogenous factors to modify the acute tissue tolerance are a) metabolic/other diseases with macro- or microangiopathia (17 answers [a]/32% mean decrease of tissue tolerance), b) collagen diseases (9 a/37%) and c) immune diseases (5 a/53%). As endogenous response modifiers for the TD 5/5 are recognized a) metabolic or other diseases leading to macro- or microangiopathia (15 a/31%), b) collagen diseases (11 a/38%) and c) immune diseases (2 a/50%). Inflammations from any reason are assumed to alter the acute tissue tolerance by (6 a/26%) and the TD 5/5 by (10 a/24%). Exogenous modifiers of the acute tissue response mentioned are a) smoking (34 a/44%), b) alcohol (23 a/45%), c) nutrition/diets (16 a/45%), d) hygiene (9 a/26%) and e) medical therapies (10 a/37%). Exogenous factors assumed to influence the TD 5/5 are a) smoking (22 a/40%), b) alcohol (15 a/38%), c) nutrition/diets (9 a/48%), d) hygiene (5 a/34%) and e) medical therapies (10 a/30%). CONCLUSIONS: Exogenous factors are regarded more important by number and extent on the acute and late tissue response than endogenous modifiers. Both may have an important influence on the individual expression of normal tissue response.

Topographic documentation of acute radiation morbidity.

BACKGROUND: The clinical knowledge on the frequency and severity of acute radiation morbidity is very sparse. With established morbidity recording, only severe side effects are revealed. The lower morbidity (I/II degree) as a major part of the data base is neglected. Another problem may be the lack of interdisciplinary and international compatibility in other systems. For these reasons, our intention was to create an easily acceptable, international and interdisciplinary compatible documentation form for routine use in radiotherapy. METHODS: A detailed topographic documentation sheet for each major topographic site of clinical radiation oncology has been developed (CNS, head and neck, thorax, female breast, abdomen, extremities). It is based upon existing toxicity codes and documentation systems (CTC[WHO], RTOG and EORTC, DEGRO, ADT, KIEL). Furthermore, basic oncological data like TNM, previous surgery or chemotherapy, drugs and more are included. For each topographic body site, one DIN A4 format is required for documentation of a 6 to 7-week treatment course. The toxicity prescription is coded according to the "DEGRO/RTOG Coding System for acute side effects" and to the "EORTC Acute Toxicity Code" to achieve optimal international and interdisciplinary compatibility. RESULTS: Complete documentation of toxicities level 0 to 4 is to be performed within 2 to 5 minutes per week/patient within preformed marks. The clinical performance has proven excellent. Not only level III/IV toxicities are recorded, but also level I/II morbidity. CONCLUSIONS: The topographic documentation system improves recording of acute morbidity in radiation oncology not only by time, but also in quality. Experimental, radiobiological and former clinical data may be proved for their actual plausibility.

Electronical recording and evaluation of acute radiation morbidity.

BACKGROUND: Relatively uniform documentation systems are used for recording of acute side effects in oncology. Object of this work is to illustrate the applicability of electronic data bases for registration and evaluation of acute side effects in radiation therapy. METHODS: Based on topographic documentation sheets, an electronic data base was developed for each major topographic site. Besides general patient related parameters (TNM, previous chemotherapy, surgical interventions, intercurrent diseases and more), the kind and the degree of acute radiation related side effects are documented for each week of radiation and for day 90 (RTOG) as the joint day between acute and subacute tissue reactions. RESULTS: The temporal expenditure for the recording of the general patient related parameters of a patient is less than a minute. The weekly documentation can be performed during the daily routine work and needs approximately 5 minutes per week. The structure of the data base enables for later analyses of acute radiation related morbidity. CONCLUSIONS: Electronic data bases enable a fast and systematic recording and evaluation of acute radiation related side effects. The development of particular registration entities for recording of acute side effects may be a possible application and demonstrates the needs of professional developments.

Radiotherapy-induced emesis. An overview.

BACKGROUND: A significant number of patients receiving radiotherapy experience the distressing side effects of emesis and nausea. These symptoms are some of the most distressing problems for the patients influencing their quality of life. METHODS: International study results concerning radiotherapy-induced emesis are demonstrated. A German multicenter questionnaire examining the strategies to prevent or to treat radiotherapy-induced nausea and emesis is presented. An international analysis concerning incidence of emesis and nausea in fractionated radiotherapy patients is discussed. Finally the consensus of the consensus conference on antiemetic therapy from the Perugia International Cancer Conference V is introduced. RESULTS: Untreated emesis can lead to complications like electrolyte disorders, dehydration, metabolic disturbances and nutrition problems with weight loss. Prophylactic antiemetics are often given to patients receiving single high-dose radiotherapy to the abdomen. A survey has revealed that antiemetic prophylaxis is not routinely offered to the patients receiving fractionated radiotherapy. However, there is a need for an effective treatment of emesis for use in this group of patients, too. In 20% of patients nausea and emesis can cause a treatment interruption because of an inadequate control of symptoms. Like in chemotherapy strategies there exists high, moderate, and low emetogenic treatment regimens in radiotherapy as well. The most emetogenic potential has the total body irradiation followed by radiotherapy to the abdomen. Radiotherapy induced emesis can be treated effectively with conventional antiemetics up to 50%. CONCLUSION: Studies with total body irradiation, fractionated treatment and high-dose single exposures have clearly demonstrated the value of 5-HT3-receptor antagonist antiemetics. There is a response between 60 and 97%. There is no difference in the efficacy of the different 5-HT3-antagonists. High-risk patients should be prophylactic treated with 5-HT3-antagonists. The additional administration of glucocorticoids and benzodiazepins can optimize the response.

Pharmacological management of acute radiation morbidity.

BACKGROUND: The acute radiation morbidity may be a serious problem for the patient and may be decreased by pharmacological approaches. MATERIAL AND METHODS: A database research (Medline, Cancerlit, DIMDI, etc.) was performed in order to obtain pharmacological approaches to decrease the acute radiation morbidity. The evaluation was focused on therapeutic principles but not on special drugs. RESULTS: Different approaches may be chosen to protect healthy tissues from the effects of ionizing radiation: 1. administration of cyto- or radioprotective agents prior to irradiation, 2. administration of agents to avoid additional secondary toxicity by inflammation or superinfection during the treatment cycle (supportive care) and 3. administration of rescue agents, such as bone marrow CSFs or hyperbaric oxygen (HBO), after therapy. For radioprotection, there are reports on cellular protection by vitamine E, vitamine C, beta carotene, ribose-cysteine, glutamine, Mgcl2/adenosine triphosphate and WR-2721 (amifostine). In general, preclinical studies show that the combination of pretreatment with amifostine, irradiation, and G-CSF after radiation enhances hematologic recovery. Assessment of these combined effects, including local supportive therapies, merits further clinical investigation. There are data from prospective studies as well as from empirical clinical experience, that radioprotection and clinical supportive care may reduce the treatment related morbidity by 10 to 30% either. CONCLUSIONS: A further improvement of the therapeutic ratio is to be expected by systemically combined application of radioprotectors, supportive care and rescue agents.

Individual skin care during radiation therapy.

BACKGROUND: In many clinical settings, the irradiated patient feels additional discomfort by the inhibition of washing the treatment portals and interruption of his adapted skin care habits. MATERIAL AND METHODS: An analysis of the scientific recommendations as well as an analysis of the skin dose to the irradiated portals has been performed. An individual scheme for skin care under radiation has been developed. RESULTS: A substantial decrease of the skin dose is achieved in many modern radiation techniques. The consequent reduction of severe skin reactions allowed the use of water and mild soaps as has been approved within many radiotherapy departments. This has lead to an individualized concept for skin care under radiation treatment including the allowance of gentle washing. The skin marks may be saved by using highly tolerable adhesive plasters or small tattoo points, if they are not superfluous by using masks or single referee points instead of marks for the field borders. CONCLUSIONS: The individualized concept for skin care during radiation may offer improved life quality to the patient and may decrease the acute reactions of the skin at least in some cases.

[Prevention and therapy of acute radiation-related morbidity of the skin and mucosa. II, Recommendations of the literature]. / Prophylaxe und Therapie akuter Strahlenfolgen an Haut und Schleimhaut. Teil II: Empfehlungen der Literatur.

BACKGROUND: In a German multicenter questionnaire, answered by 89 departments, we had examined the strategies to prevent or to treat the acute morbidity of the skin and mucosa associated to radiation therapy. In this work, the recommendations from the literature are compared to the results of the questionnaire. METHODS: An extensive research on common data information systems (Medline, Cancerlit, DIMDI and others) was performed. The criteria included the organ related morbidity and therapeutic strategies for its reduction. The obtained data were compared to the results from the questionnaire. RESULTS: The study data found by the research often demonstrate small patient numbers and little convincing results. However, as in the questionnaire, the joint principle seems to be the reduction of acute inflammatory tissue reaction by evasion of bacterial and mycotic overgrowth and reduction of exo- and endogenous toxins. CONCLUSIONS: Further studies with more convincing results are required.

[Prevention and therapy of acute radiation injuries of the skin and mucosa. I. Results of a German multicenter questionnaire]. / Prophylaxe und Therapie akuter Strahlenfolgen an Haut und Schleimhaut. Teil I: Ergebnisse einer bundesweiten Erhebung.

BACKGROUND: The acute radiation related morbidity is an essential factor for the patient's outcome in radiotherapy. The prophylactic and therapeutic management of acute side effects has a wide clinical range between different radiation oncology departments. In this work, it was to evaluate the remedies, which are used for prevention and therapeutic management of acute radiation related morbidity of the skin and mucosa (mouth, pharynx, esophagus, small and large bowel, rectum and vagina). METHODS: A questionnaire was sent to 130 radiotherapeutic departments in Germany in July 1995. The questionnaire had been designed with 22 open questions concerning the preventive and therapeutic management of acute radiation related morbidity of skin and mucosal sites. It has been correlated to the scoring system of the RTOG/EORTC and its German modification according to Seegenschmiedt and Sauer. The evaluation was performed anonymously. RESULTS: From 130 questionnaires, 89 (68.4%) were sent back till August 1995. All of them were evaluable. The recommendations showed a broad spectrum for each site. Especially the oral mucositis was treated in many different ways and combinations. The prevention and therapy of complicating superinfections seem to be the joint principle of most of the recommendations. CONCLUSIONS: The management of the acute radiation related morbidity has a wide clinical spectrum among different radiation therapy centers. Systematic prospectively designed investigations are necessary in order to achieve a further reduction in the radiation related acute morbidity. Therefore, a multicenter collaborative working group has been founded.

[Spiral computed tomography for treatment planning and quality assurance in radiotherapy]. / Spiralcomputertomographie zur Bestrahlungsplanung und Qualitätssicherung in der Strahlentherapie.

BACKGROUND: The possibilities of spiral CT for radiotherapeutic treatment planning and quality assurance have been systematically investigated. PATIENTS AND METHODS: The influence of parameters such as slice thickness, table speed and increment on geometric accuracy was studied. Ring-, spheric-, PMMA- and humanoid Alderson phantoms were used. Furthermore, patients with infradiaphragmatic irradiation of Hodgkin's disease or with mediastinal irradiation were studied using CT-angiography. Patients with carcinomas of the head and neck before HDR- and PDR-brachytherapy were examined as well. RESULTS: Spiral CT offers 3D volume data information with excellent reduction of breath and motion artefacts for virtual simulation. 2D multiplanar reconstructions with excellent local resolution may be obtained. 3D MIP (Maximum Intensity Projection), based on CT-angiographic imaging, is a good tool for infradiaphragmatic treatment planning of Hodgkin's disease, if small numbers for slice thickness, table speed and increment are used. SSD (Surface Shaded Display) offers good 3D visualization and good geometric control of intracavitary and interstitial brachytherapy applicators. High qualitative multiplanar reconstructions are useful for CT-based brachytherapy planning. CONCLUSIONS: Spiral CT is a precious tool for 3D treatment planning and virtual simulation in radiotherapy and superior to conventional CT data acquisition. Quality assurance is improved for dose-volume-histograms and for brachytherapy.

[Daylight processing system in radiotherapy. Technical changes and cost benefit analysis]. / Ein Tageslichtentwicklungssystem für die Strahlentherapie. Technische Modifikation und Kosten-Nutzen-Analyse.

BACKGROUND: In radiotherapy portal and verification imaging take an important place in daily quality assurance procedures. Different types of films and cassettes have to be used to gain an optimal result for photon and electron beams. MATERIALS AND METHODS: We describe a modification of a machine for daylight processing, which has been technically enabled not only to process all X-rays from simulator, brachytherapy, CT and MRI but all film materials from portal and verification imaging as well without changing system's configuration. Using a light gap, verification films are automatically differentiated from portal films or from film material from simulation and the cassettes are automatically loaded with the new verification film. Furtheron, we took some attention on cost effectivity. RESULTS: The daylight processing machine is sufficiently integrated into daily routine work load and spares a lot of staff time. Higher primary costs are overbalanced within a few years by lower supporting costs (Table 1). This is especially due to lower film material costs (Table 2), but also a result of staff time reduction. CONCLUSIONS: Radiotherapeutic departments may gain much comfort using a daylight processing machine as development unit.

[The new possibilities of digital luminescence radiography (DLR) and digital imaging data processing for the making of field verification images]. / Neue Möglichkeiten von digitaler Lumineszenzradiographie (DLR) und digitaler Bilddatenverarbeitung für die Erstellung von Feldkontrollaufnahmen.

BACKGROUND: Treatment verification for reasons of quality control takes an important place in daily radiotherapeutic work. The quality of conventional, e.g. not digital imaging methods, is often poor. Moreover, portal and verification imaging are commonly used only for photon beam control; even digital portal radiographs were not suitable for verification of electron beams, rotation beams, conformation therapy or dynamic multileaf collimation yet. MATERIALS AND METHODS: We developed a method, using digital luminescence radiography (DLR), not only for portal imaging of photon beams in an excellent quality, but also for verification of electron beams. Further on, DLR was used as basic instrument for image fusion of portal and verification film and simulation film respectively for image processing in "beams-eye-view" verification (BEVV) of rotating beams or conformation therapy. RESULTS: Digital radiographs of an excellent quality are gained for verification of photon and electron beams. In photon beams, quality improvement vs. conventional portal imaging may be dramatic, even more for high energy beams (e.g. 15-MV-photon beams) than for Co-60. In electron beams, excellent results may be easily obtained. By digital image fusion of 1 or more verification films on simulation film or MRI-planning film, more precise judgement even on small differences between simulation and verification films becomes possible. Using BEVV, it is possible to compare computer aided simulation in rotating beams or conformation therapy with the really applied treatment. The basic principle of BEVV is also suitable for dynamic multileaf collimation. CONCLUSIONS: DLR is a multipotent and suitable method for many aspects of imaging treatment verification.