Hintergrund/FragestellungElektrolytstörungen in Folge eines operativen Eingriffs an der Hypophyse sind häufige und ernstzunehmende Komplikationen, welche mit verlängerter Hospitalisationsdauer beziehungsweise erneuter Hospitalisierung, intensivmedizinischer Betreuung und somit verzögerter postoperativer Erholung einhergehen. Diabetes Insipidus (DI) und verzögerte symptomatische Hyponatriämie (DSH) sind postoperativ die häufigsten frühen endokrinen Komplikationen, wobei «Syndrome of Inappropriate Antidiuresis» (SIADH) die häufigste Ursache für DSH zu sein scheint. Ziel dieser Arbeit ist es, Risikofaktoren (RF) zu identifizieren, welche die präoperative Vorhersage der obengenannten Komplikationen ermöglichen würden. Methoden Für diese Arbeit wurden Patienten, die an postoperativem DI und/oder SIADH litten, identifiziert. Die analysierten Daten stammen aus einem prospektiven Register von Hypophysenadenom-Patienten, welche mittels transsphenoidaler Hypophysenchirurgie (TSS) therapiert wurden. Zur Identifizierung von unabhängigen Faktoren, welche mit dem Auftreten von postoperativem DI beziehungsweise SI-ADH assoziiert sind, wurden uni-und multivariable statistische Modelle verwendet. Resultate Insgesamt wurden 174 Patienten eingeschlossen. Während des postoperativen Krankenhausaufenthalts wurden 13 (7,5%) Patienten mit DI und 11 (6,3%) mit SIADH diagnostiziert. Sowohl Patienten, die nach der Operation einen DI entwickelten, als auch Patienten, die an SIADH litten, hatten signifikant längere Krankenhausaufenthalte (p=0,022 für DI und p=0,002 für SIADH). Zum Zeitpunkt der Entlassung hatten 4 (2,3%) Patienten die Diagnose eines persistierenden DI und 2 (1,1%) die Diagnose eines SIADH. Bei der letzten Nachkontrolle litten 5 (2,9%) Patienten an einem persistierenden DI, keiner der Patienten an SIADH. Das Auftreten von DI war schwach mit jüngerem Alter (Odds ratio (OR):

OBJECTIVERandomized controlled trials (RCTs) form the basis of today’s evidence-based approach to medicine, and play a critical role in guidelines and the drug and device approval process. Conflicts of interest (COIs) are commonplace in medical research, but little is known about their influence. The authors aimed to evaluate the extent and influence of COIs in recent RCTs published in core neurosurgical journals using a cross-sectional analysis.METHODSThrough review of 6 general neurosurgical journals, all interventional RCTs published from January 2009 to January 2019 were identified. Because it is difficult to objectively assess study outcome, the authors opted for a strict rating approach based on the statistical significance of unambiguously reported primary endpoints, and the reported statistical protocol.RESULTSA total of 129 RCTs met the inclusion criteria. During the study period, the Journal of Neurosurgery published the largest number of RCTs (n = 40, 31%). Any potential COI was disclosed by 57%, and a mean of 12% of authors had a personal COI. Nonfinancial industry involvement was reported in 10%, while 31% and 20% received external support and sponsoring, respectively. Study registration was reported by 56%, while 51% of studies were blinded. Registration showed an increasing trend from 17% to 76% (p < 0.001). The median randomized sample size was 92 (interquartile range 50–153), and 8% were designed to investigate noninferiority or equality. Sixty-three RCTs (49%) unambiguously reported a primary endpoint, of which 13% were composite primary endpoints. In 43%, study outcome was positive, which was associated with a noninferiority design (31% vs 3%, p = 0.007) and a composite primary endpoint (46% vs 9%, p = 0.002). Potential COIs were not significantly associated with study positivity (69% vs 59%, p = 0.433). In the multivariate analysis, only a composite primary endpoint remained predictive of a positive study outcome (odds ratio 6.34, 95% confidence interval 1.51–33.61, p = 0.017).CONCLUSIONSThis analysis provides an overview of COIs and their potential influence on recent trials published in core neurosurgical journals. Reporting of primary endpoints, study registration, and uniform disclosure of COIs are crucial to ensure the quality of future neurosurgical randomized trials. COIs do not appear to significantly influence the outcome of randomized neurosurgical trials.

Currently, cholecystectomy is performed laparoscopically. While the conventional approach (CA) with four access ports persists, other methods seek to reduce trauma or to optimize cosmetic results. In this study, the safety and cosmetic outcome of a suprapubic approach (SA) were evaluated. Between 2015 and 2016, patients undergoing elective cholecystectomy either by CA or by a suprapubic approach (SA) at our institution were included. The cosmetic outcome, postoperative morbidity, operative time and length of stay were evaluated. Pictures of the site of intervention were taken 6–12 months postoperatively and rated on a scale from 1 (unsatisfying aesthetic result) to 5 (excellent aesthetic result). Five “non-medical” and five “medical” raters as well as one board-certified plastic surgeon performed the ratings. A total of 70 patients were included (n = 28 SA, n = 42 CA). The two groups did not differ in baseline characteristics (age, gender, BMI). The SA group showed a significantly better aesthetic outcome compared to the CA group 4.8 (4.8–4.9) vs. 4.2 (3.8–4.4), (p > 0.001). Medical raters: 4.0 (3.8–4.2) vs. 4.8 (4.6–5.0), (p < 0.001); non-medical raters: 4.2 (3.8–4.6) vs. 5.0 (4.8–5.0), (p < 0.001); plastic surgeon: 4.0 (4.0–4.0) vs. 5.0 (5.0–5.0), (p < 0.001). Fair interrater consistency was demonstrated with an ICC of 0.47 (95% CI = 0.38–0.57). No significant difference in the complication rate (1 (3.5%) in SA vs. 6 (14%) in CA, (p = 0.3)), or the operating time 66 (50–86) vs. 70 (65–82) min, (p = 0.3), were observed. Patients stayed for a median of three (3–3) days in the SA group and 3 (3–4) days in the CA group (p = 0.08). This study demonstrated that the suprapubic approach is an appropriate alternative to conventional laparoscopic cholecystectomy, presenting a better cosmetic outcome with a similar complication rate.