IntroductionIncisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been ...studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.Methods and analysisWe will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.Ethics and disseminationNo new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.PROSPERO registration numberCRD42022347881.
Analyses of infection chains have demonstrated that severe acute respiratory syndrome coronavirus 2 is highly transmissive. However, data on postmortem stability and infectivity are lacking. Our ...finding of nasopharyngeal viral RNA stability in 79 corpses showed no time-dependent decrease. Maintained infectivity is supported by virus isolation up to 35 hours postmortem.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, ODKLJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Purpose
Controversies exist in regard to surgical neck management in total laryngectomies (TL). International guidelines do not sufficiently discriminate neck sides and sublevels, or minimal ...neck-dissection nodal yield (NY).
Methods
Thirty-seven consecutive primary TL cases from 2009 to 2019 were retrospectively analyzed in terms of local tumor growth using a previously established imaging scheme, metastatic neck involvement, and NY impact on survival.
Results
There was no case of level IIB involvement on any side. For type A and B tumor midline involvement, no positive contralateral lymph nodes were found. Craniocaudal tumor extension correlated with contralateral neck involvement (OR: 1.098,
p
= 0.0493) and showed increased involvement when extending 33 mm (
p
= 0.0134). Using a bilateral NY of ≥ 24 for 5-year overall survival (OS) and ≥ 26 for 5-year disease-free survival (DFS) gave significantly increased rate advantages of 64 and 56%, respectively (both
p
< 0.0001).
Conclusions
This work sheds light on regional metastatic distribution pattern and its influence on TL cases. An NY of
n
≥ 26 can be considered a desirable benchmark for bilateral selective neck dissections as it leads to improved OS and DFS. Therefore, an omission of distinct neck levels cannot be promoted at this time.
We investigated the infectivity of 128 severe acute respiratory disease coronavirus 2-associated deaths and evaluated predictive values of standard diagnostic procedures. Maintained infectivity (20%) ...did not correlate with viral RNA loads but correlated well with anti-S antibody levels. Sensitivity >90% for antigen-detecting rapid diagnostic tests supports their usefulness for assessment.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, ODKLJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Purpose
Analog and digital impressions are established procedures for restoration of single‐tooth implants. In this study, single‐tooth implants were restored with definitive restorations during ...second‐stage surgery. Analog and digital workflows were compared.
Material and Methods
Eighty single‐tooth implants were examined in total. In 40 implants, an index was taken immediately after implant placement using composite resin to fabricate the final crowns (analog workflow). For the other 40 single‐tooth implants, intraoral intraoperative scans were performed (digital workflow) during primary surgery. The custom‐fabricated screw‐retained crowns were placed during second‐stage surgery. Photographs and examinations for the scores were taken at the time of the follow‐up visit, 1–4 years after placement of the crowns. The number of treatment appointments required was recorded and the modified pink esthetic score (PES) was determined. Additionally, the functional implant prosthetic score (FIPS) was measured.
Results
The mean PES was 12.15/14 for the digital workflow and 11.95/14 for the analog workflow. The most common deficit was incomplete papillae for both workflows. Three treatment appointments were required for both workflows: (1) Scan and/or impressions making and patient consent, (2) implant placement, and (3) second‐stage surgery with crown insertion. The FIPS was 9.1/10 for the digital workflow group and 9.2/10 for the analog workflow group. Common deficits presented as missing papillae as well as open approximal contacts. The FIPS was not significantly different between workflows (p = 0.679). The PES also did not show a statistically significant difference for both workflows (p = 0.654), however, the analog workflow showed better values for the papillae (p < 0.05). A significant difference was also found in the other PES values, with the digital workflow showing better results here (p < 0.05). A chronological analysis of the results of the digital technique showed that the cases treated last had significantly better values than the cases treated first.
Conclusions
According to the results of this study, both workflows allowed placement of the definitive crowns on single‐tooth implants during second‐stage surgery. Both workflows were found to be equivalent in terms of esthetic results in this study, although the digital workflow demonstrated a learning curve.
New diagnostic tests to identify a well-established disease state must undergo a series of scientific studies from test construction to finally demonstrating a societal impact. Traditionally, these ...studies are performed with substantial time gaps in between, resulting in a long time period from the initial idea to roll out in clinical practice including reimbursement. Seamless designs allowing us to combine a sequence of studies in one protocol may hence accelerate this process. Currently, a systematic investigation of the potential of seamless designs in diagnostic research is lacking.
We identify major study types in diagnostic research and their basic characteristics with respect to the application of seamless designs. This information is used to identify major hurdles and opportunities for seamless designs.
The following major study types were identified: Variable construction studies, cut point finding studies, variable value studies, single-arm accuracy studies, comparative accuracy studies, change-in-management studies, observational discordant pair studies, randomized discordant pair studies, and randomized diagnostic studies. The following characteristics were identified: Type of recruitment (case-control vs. population-based), application of a reference standard, inclusion of a comparator, paired or unpaired application of a comparator, assessment of patient-relevant outcomes, and possibility for blinding of test results.
Two basic hurdles could be identified: 1) Accuracy studies are hard to combine with postaccuracy studies in a seamless design for the following reasons. First, because the former are required to justify the latter and application of a reference test in outcome studies may be a threat to the integrity of the study. 2) Randomized diagnostic studies are probably best placed as singular studies at the end of the process, as all other questions should be clarified before performing such a study.
However, otherwise there is a substantial potential for seamless designs. All steps from the construction to the comparison with the comparator can be combined in one protocol. This may include a switch from case-control to population-based recruitment as well as a switch from a single-arm study to a comparative accuracy study. In addition, change-in-management studies can be combined with an outcome study in discordant pairs.
There is a potential for seamless designs in diagnostic research. It is wise to have the whole sequence of necessary studies in mind and to plan a full programme than rather individual studies one by one.
•Seamless designs are not only fruitful in intervention research, but also in diagnostic research.•Studying change in management can easily be combined with studying outcomes in discordant pairs.•All steps from construction until determining comparative accuracy can be combined within one seamless design.•Detailed guidelines for seamless designs in diagnostic research should be developed.
Background
Although the Clavien–Dindo classification is well established in many fields of surgery, a conclusive severity grading system for liver surgery–specific complications has not yet been ...standardized. Post-hepatectomy liver
F
ailure,
A
scites,
B
ile leakage,
I
nfection, and
B
leeding were found to be the five most important components in an international survey. A score system with FABIB as the acronym was proposed by the authors to increase the feasibility of routine use.
Methods
The definition and grading of three components (“liver failure,” “bile leakage,” and “bleeding”) were adopted from the International Study Group for Liver Surgery. The definition and grading for “ascites” as well as “infection” were proposed by the authors. The postoperative complications were documented prospectively. The data from 2012 to 2016 were reviewed and the correlations to other clinical parameters were analyzed retrospectively.
Results
Five hundred one consecutive liver resections were assessed. Two hundred twenty-four (44.7%) patients had at least one postoperative complication of the FABIB system. The FABIB score was found to correlate with the operation complexity (major vs minor liver resection, with or without biliodigestive anastomosis), underlying liver disease (normal liver parenchyma vs fibrosis vs cirrhotic liver), 90-day mortality (statistically significantly different within three predefined categories), and the length of hospital stay (the mean value increases proportionately to FABIB score).
Conclusion
Using the FABIB reporting system, the five main complications after liver surgery can be documented in a standardized manner. Its clinical relevance might increase the feasibility and comparability of studies or trials in liver surgery.
A severity grading system for liver surgery-specific complications, given the acronym FABIB, has been standardized to increase the feasibility and comparability of academic reports in liver surgery. ...Whether the FABIB score is associated with long-term survival following major hepatectomy has not been previously investigated.
297 consecutive patients who had undergone major hepatectomy between 2012 and 2019 were recruited. The postoperative complications were documented according to the FABIB system and, for comparison purposes, Clavien-Dindo classification. Their influence on 90-day mortality and long-term survival was analyzed retrospectively.
Taking the relevant confounders into account, the FABIB score was a robust factor associated with long-term survival after major hepatectomy: patients with high FABIB scores (≥6) had a 2.415-fold higher risk of death compared to patients with low FABIB scores (≤2) (P = 0.002). In contrast to that, the Clavien-Dindo Classification (grade III + IV vs. grade I + II) was not associated with survival in our cohort (P = 0.873).
Liver surgery-specific complications, measured by the FABIB system, impact long-term survival after major hepatectomy independent of relevant confounders. We propose the FABIB score as a composite endpoint for randomized controlled trials and a quality assessment tool in liver surgery.
PURPOSETo determine the histological effects of ultraviolet light and cold atmospheric plasma treatment on the osseointegration of titanium implants in vivo. MATERIALS AND METHODSSix juvenile pigs ...were divided into three groups of two animals each. A total of 54 titanium implants were placed randomly in the pigs' calvarial bone (nine implants per pig). Of these, 18 implants served as untreated controls. The remaining 36 implants served as the experimental group and were treated with either ultraviolet light or argon plasma for 12 minutes each prior to insertion. Two pigs in each group were kept until 2, 4 and 8 weeks and then sacrificed. Resonance frequency analysis was conducted after implant placement and at the time of sacrifice. Osseointegration was evaluated using microcomputed tomography scans and histomorphometrical analysis. RESULTSAfter initial loss, all implants showed a constant increase in implant stability quotient values over time without significant differences between the groups. The bone-implant contact values increased steadily for all implants over 8 weeks of healing. Surface-treated implants showed significantly higher bone-implant contact values compared to untreated implants at each time point. Bone area fraction occupancy values were almost always higher following both treatment methods; however, differences were only significant after 4 and 8 weeks for the cold atmospheric plasma group and after 4 weeks for the ultraviolet light group. CONCLUSIONSUltraviolet light and cold atmospheric plasma may improve histomorphometrical osseointegration of titanium implants significantly.
This study was conducted to determine the effect of hypothermic temperature control after in-hospital cardiac arrest (IHCA) on mortality and functional outcome as compared with normothermia.
An ...investigator initiated, open-label, blinded-outcome-assessor, multicenter, randomized controlled trial comparing hypothermic temperature control (32-34°C) for 24 h with normothermia after IHCA in 11 hospitals in Germany. The primary endpoint was all-cause mortality after 180 days. Secondary end points included in-hospital mortality and favorable functional outcome using the Cerebral Performance Category scale after 180 days. A Cerebral Performance Category score of 1 or 2 was defined as a favorable functional outcome.
A total of 1055 patients were screened for eligibility and 249 patients were randomized: 126 were assigned to hypothermic temperature control and 123 to normothermia. The mean age of the cohort was 72.6±10.4 years, 64% (152 of 236) were male, 73% (166 of 227) of cardiac arrests were witnessed, 25% (57 of 231) had an initial shockable rhythm, and time to return of spontaneous circulation was 16.4±10.5 minutes. Target temperature was reached within 4.2±2.8 hours after randomization in the hypothermic group and temperature was controlled for 48 hours at 37.0°±0.9°C in the normothermia group. Mortality by day 180 was 72.5% (87 of 120) in hypothermic temperature control arm, compared with 71.2% (84 of 118) in the normothermia group (relative risk, 1.03 95% CI, 0.79-1.40;
=0.822). In-hospital mortality was 62.5% (75 of 120) in the hypothermic temperature control as compared with 57.6% (68 of 118) in the normothermia group (relative risk, 1.11 95% CI, 0.86-1.46,
=0.443). Favorable functional outcome (Cerebral Performance Category 1 or 2) by day 180 was 22.5% (27 of 120) in the hypothermic temperature control, compared with 23.7% (28 of 118) in the normothermia group (relative risk, 1.04 95% CI, 0.78-1.44;
=0.822). The study was prematurely terminated because of futility.
Hypothermic temperature control as compared with normothermia did not improve survival nor functional outcome at day 180 in patients presenting with coma after IHCA. The HACA in-hospital trial (Hypothermia After Cardiac Arrest in-hospital) was underpowered and may have failed to detect clinically important differences between hypothermic temperature control and normothermia.
URL: https://www.
gov; Unique Identifier: NCT00457431.
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