Silke Allekotte

Hemorrhage rate after coblation tonsillectomy: a meta-analysis of published trials

After the surgical procedure of tonsillectomy, hemorrhage ranks among its serious postoperative complications. In this systematic review, we analyze hemorrhage following tonsillectomies performed using the coblation technique. 24 prospective, randomized, and controlled studies were included in the meta-analysis. Data of 796 patients who had undergone coblation tonsillectomy were analyzed. Hemorrhages occurred in 33 patients: 2 classified as primary and 26 as secondary hemorrhages. 5 could not be classified into either group. Overall, the total hemorrhage rate for the coblation procedure was 4.1% with a 95% confidence interval from 2.8 to 5.5%. The overall hemorrhage rate of 4.1% found in this meta-analysis shows that coblation is a safe and effective technique for tonsillectomies with a secondary bleeding rate similar to what is reported for comparable techniques such as bipolar diathermia.

A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite allergic patients.

In sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose.

Digitally Analyzed Conjunctival Redness: Does Repeated Conjunctival Provocation Intrinsically Cause Local Desensitization of the Eye?

Background: Allergic reactions in patients with seasonal or perennial rhinoconjunctivitis mediated by airborne allergens can be effectively assessed with the conjunctival provocation test (CPT). The CPT is a fast and easy diagnostic procedure that challenges the ocular mucosa with instillations of allergen solutions into the conjunctival region. This paper aimed to investigate the possible influence of repeated diagnostic CPT procedures on the patients clinical presentation, i.e. to analyze desensitization effects caused by diagnostic solutions and to show the reproducibility of CPT results. Methods: Treatment progress in 120 placebo-treated patients from 2 immunotherapeutic dose-finding studies was estimated and documented, as based on the CPT which was applied at 4 visits with intervals of 4, 8 and 16 weeks. High-resolution digital photos collected as part of the CPT documentation were analyzed by an external observer and by digital analysis software to determine conjunctival redness, completely independent of the subjectivity of investigators and patients. Results: Two extremal scenarios of the redness changes were considered after provocation with 10,000 standard quality units/ml. A maximal decrease of about 3% (t test: p = 0.0002; U test: p = 0.001) and a minimal decrease of about 1% (t test: p = 0.254; U test: p = 0.431) were found. Conclusions: The observed decrease in conjunctival hyperemia can be explained by local desensitization or by placebo effect. Due to the setup of both studies considered, we could not ascertain how these factors influence the decrease in redness. In order to attribute the observed effects to local conjunctival desensitization with certainty, further pilot studies are needed.

Lolium perenne peptide immunotherapy is well tolerated and elicits a protective B-cell response in seasonal allergic rhinitis patients

Systemic allergic reactions are a risk for allergen immunotherapy that utilizes intact allergen preparations. We evaluated the safety, efficacy and immune mechanisms of short‐course treatment with adjuvant‐free Lolium perenne peptides (LPP) following a 6‐week dose‐escalation protocol.

Nachblutungsrate nach Coblation-Tonsillektomie

BACKGROUND With over 100,000 cases annually, tonsillectomy is one of the most frequently performed ENT surgical procedures in Germany. Hemorrhage ranks among its serious postoperative complications. In this systematic review, we analyze hemorrhage following tonsillectomies performed using coblation technique. METHODS Of the 135 studies identified, 38 could be included in the analysis, most being prospective randomized controlled studies. Data from 6290 patients were gathered. RESULTS Of all tonsillectomies performed, hemorrhages occurred in 355 patients. Of these, 256 cases could be classified as 41 primary and 215 secondary hemorrhages. Overall, the total hemorrhage rate for the coblation procedure was 4.9% (95%-CI: 0.044-0.054) for the fixed effects model. CONCLUSION Significantly higher rates of postoperative hemorrhage were found in a few studies, yet they were well above the 95% confidence interval of 4.4-5.4% of the literature. These studies could possibly be interpreted in terms of an autodidactic learning process. As with any surgical technique, proper training is essential.ZusammenfassungHintergrundDie Tonsillektomie ist in Deutschland einer der häufigsten Eingriffe im HNO-Bereich (über 100.000 Eingriffe/Jahr). Zu den schweren postoperativen Komplikationen zählt auch die Nachblutung. In der vorliegenden systematischen Übersicht wird die Nachblutung nach Tonsillektomien unter Anwendung der Coblation-Technik analysiert und ausgewertet.MethodenEs wurden 135 Studien gefunden, von denen 38 in die Analyse eingeschlossen werden konnten. Aus diesen zumeist prospektiven, randomisierten, kontrollierten Studien wurden Daten von 6290 Patienten erfasst. ErgebnisseBei 355 dieser Patienten kam es zu einer Nachblutung. Davon konnten 256 klassifiziert werden als 41 primäre und 215 sekundäre Blutungen. Insgesamt ergibt sich aus den 38 verfügbaren Studien eine Nachblutungsrate für das Coblation-Verfahren von 4,9% (95%-KI: 0,044–0,054) bei Annahme des Fixed-Effects-Modells.FazitIn einzelnen Studien gab es beträchtlich höhere Raten der postoperativen Nachblutung, jedoch lagen sie deutlich oberhalb des 95%-KI von 4,4–5,4% in der Literatur. Diese Studien sind evtl. als autodidaktischer Lernprozess zu interpretieren. Wie bei allen operativen Techniken ist auch hier ein angemessenes Training erforderlich.AbstractBackgroundWith over 100,000 cases annually, tonsillectomy is one of the most frequently performed ENT surgical procedures in Germany. Hemorrhage ranks among its serious postoperative complications. In this systematic review, we analyze hemorrhage following tonsillectomies performed using coblation technique.MethodsOf the 135 studies identified, 38 could be included in the analysis, most being prospective randomized controlled studies. Data from 6290 patients were gathered.ResultsOf all tonsillectomies performed, hemorrhages occurred in 355 patients. Of these, 256 cases could be classified as 41 primary and 215 secondary hemorrhages. Overall, the total hemorrhage rate for the coblation procedure was 4.9% (95%-CI: 0.044–0.054) for the fixed effects model.ConclusionSignificantly higher rates of postoperative hemorrhage were found in a few studies, yet they were well above the 95% confidence interval of 4.4–5.4% of the literature. These studies could possibly be interpreted in terms of an autodidactic learning process. As with any surgical technique, proper training is essential.

[Hemorrhage rates following coblation tonsillectomy. A meta-analysis of published trials].

BACKGROUND With over 100,000 cases annually, tonsillectomy is one of the most frequently performed ENT surgical procedures in Germany. Hemorrhage ranks among its serious postoperative complications. In this systematic review, we analyze hemorrhage following tonsillectomies performed using coblation technique. METHODS Of the 135 studies identified, 38 could be included in the analysis, most being prospective randomized controlled studies. Data from 6290 patients were gathered. RESULTS Of all tonsillectomies performed, hemorrhages occurred in 355 patients. Of these, 256 cases could be classified as 41 primary and 215 secondary hemorrhages. Overall, the total hemorrhage rate for the coblation procedure was 4.9% (95%-CI: 0.044-0.054) for the fixed effects model. CONCLUSION Significantly higher rates of postoperative hemorrhage were found in a few studies, yet they were well above the 95% confidence interval of 4.4-5.4% of the literature. These studies could possibly be interpreted in terms of an autodidactic learning process. As with any surgical technique, proper training is essential.ZusammenfassungHintergrundDie Tonsillektomie ist in Deutschland einer der häufigsten Eingriffe im HNO-Bereich (über 100.000 Eingriffe/Jahr). Zu den schweren postoperativen Komplikationen zählt auch die Nachblutung. In der vorliegenden systematischen Übersicht wird die Nachblutung nach Tonsillektomien unter Anwendung der Coblation-Technik analysiert und ausgewertet.MethodenEs wurden 135 Studien gefunden, von denen 38 in die Analyse eingeschlossen werden konnten. Aus diesen zumeist prospektiven, randomisierten, kontrollierten Studien wurden Daten von 6290 Patienten erfasst. ErgebnisseBei 355 dieser Patienten kam es zu einer Nachblutung. Davon konnten 256 klassifiziert werden als 41 primäre und 215 sekundäre Blutungen. Insgesamt ergibt sich aus den 38 verfügbaren Studien eine Nachblutungsrate für das Coblation-Verfahren von 4,9% (95%-KI: 0,044–0,054) bei Annahme des Fixed-Effects-Modells.FazitIn einzelnen Studien gab es beträchtlich höhere Raten der postoperativen Nachblutung, jedoch lagen sie deutlich oberhalb des 95%-KI von 4,4–5,4% in der Literatur. Diese Studien sind evtl. als autodidaktischer Lernprozess zu interpretieren. Wie bei allen operativen Techniken ist auch hier ein angemessenes Training erforderlich.AbstractBackgroundWith over 100,000 cases annually, tonsillectomy is one of the most frequently performed ENT surgical procedures in Germany. Hemorrhage ranks among its serious postoperative complications. In this systematic review, we analyze hemorrhage following tonsillectomies performed using coblation technique.MethodsOf the 135 studies identified, 38 could be included in the analysis, most being prospective randomized controlled studies. Data from 6290 patients were gathered.ResultsOf all tonsillectomies performed, hemorrhages occurred in 355 patients. Of these, 256 cases could be classified as 41 primary and 215 secondary hemorrhages. Overall, the total hemorrhage rate for the coblation procedure was 4.9% (95%-CI: 0.044–0.054) for the fixed effects model.ConclusionSignificantly higher rates of postoperative hemorrhage were found in a few studies, yet they were well above the 95% confidence interval of 4.4–5.4% of the literature. These studies could possibly be interpreted in terms of an autodidactic learning process. As with any surgical technique, proper training is essential.

RCAT reflects symptom control and quality of life in allergic rhinoconjunctivitis patients

The Global Allergy and Asthma European Network (GA2LEN) Taskforce has requested more data on correlations between various patient‐reported outcomes (PROs) in clinical trials on allergy. We compared three tools—the Rhinitis Control Assessment Test (RCAT), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Rhinitis Total Symptom Score (RTSS)—to determine whether the RCAT alone is a sufficient primary outcome parameter in clinical trials on allergic rhinoconjunctivitis.

Qualitätsmanagement an einer klinischen Forschungseinrichtung: Evaluation der Veränderungen der hausinternen Qualitätskennzahlen sowie Ermittlung von hausinternen Qualitätsindikatoren

For long-term maintenance and improvement of quality within a clinical research institute, the implementation and certification of a quality management system is suitable. Due to the implemented quality management system according to the still valid DIN EN ISO 9001:2008 desired quality objectives are achieved effectively. The evaluation of quality scores and the appraisal of in-house quality indicators make an important contribution in this regard. In order to achieve this and draw quality assurance conclusions, quality indicators as sensible and sensitive as possible are developed. For this, own key objectives, the retrospective evaluation of quality scores, a prospective follow-up and also discussions establish the basis. In the in-house clinical research institute the measures introduced by the quality management led to higher efficiency in work processes, improved staff skills, higher customer satisfaction and overall to more successful outcomes in relation to the self-defined key objectives.

Qualität und Sicherheit in der Gesundheitsversorgung / Quality and Safety in Health CareQualitätsmanagement an einer klinischen Forschungseinrichtung: Evaluation der Veränderungen der hausinternen Qualitätskennzahlen sowie Ermittlung von hausinternen QualitätsindikatorenQuality management in a clinical research facility: Evaluation of changes in quality in-house figures and the appraisal of in-house quality indicators

For long-term maintenance and improvement of quality within a clinical research institute, the implementation and certification of a quality management system is suitable. Due to the implemented quality management system according to the still valid DIN EN ISO 9001:2008 desired quality objectives are achieved effectively. The evaluation of quality scores and the appraisal of in-house quality indicators make an important contribution in this regard. In order to achieve this and draw quality assurance conclusions, quality indicators as sensible and sensitive as possible are developed. For this, own key objectives, the retrospective evaluation of quality scores, a prospective follow-up and also discussions establish the basis. In the in-house clinical research institute the measures introduced by the quality management led to higher efficiency in work processes, improved staff skills, higher customer satisfaction and overall to more successful outcomes in relation to the self-defined key objectives.

Quality management in a clinical research facility: Evaluation of changes in quality in-house figures and the appraisal of in-house quality indicators

For long-term maintenance and improvement of quality within a clinical research institute, the implementation and certification of a quality management system is suitable. Due to the implemented quality management system according to the still valid DIN EN ISO 9001:2008 desired quality objectives are achieved effectively. The evaluation of quality scores and the appraisal of in-house quality indicators make an important contribution in this regard. In order to achieve this and draw quality assurance conclusions, quality indicators as sensible and sensitive as possible are developed. For this, own key objectives, the retrospective evaluation of quality scores, a prospective follow-up and also discussions establish the basis. In the in-house clinical research institute the measures introduced by the quality management led to higher efficiency in work processes, improved staff skills, higher customer satisfaction and overall to more successful outcomes in relation to the self-defined key objectives.