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Nevin Manimala Statistics

Low-pressure pneumoperitoneum with deep neuromuscular blockade versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: a non-inferiority randomized control trial

Surg Endosc. 2023 Nov 27. doi: 10.1007/s00464-023-10558-0. Online ahead of print.

ABSTRACT

BACKGROUND: Low-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB.

METHODOLOGY: This was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8-10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1-2] and Group B: SPP; 12-14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported.

RESULTS: Of the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable.

CONCLUSION: LPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.

PMID:38012441 | DOI:10.1007/s00464-023-10558-0

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Portal vein velocity predicts portal vein system thrombosis after splenectomy with esophagogastric devascularization

Surg Endosc. 2023 Nov 27. doi: 10.1007/s00464-023-10566-0. Online ahead of print.

ABSTRACT

BACKGROUND: Portal vein system thrombosis (PVST) is a potentially fatal complication after splenectomy with esophagogastric devascularization (SED) in cirrhotic patients with portal hypertension. However, the impact of portal vein velocity (PVV) on PVST after SED remains unclear. Therefore, this study aims to explore this issue.

METHODS: Consecutive cirrhotic patients with portal hypertension who underwent SED at Tongji Hospital between January 2010 and June 2022 were enrolled. The patients were divided into two groups based on the presence or absence of PVST, which was assessed using ultrasound or computed tomography after the operation. PVV was measured by duplex Doppler ultrasound within one week before surgery. The independent risk factors for PVST were analyzed using univariate and multivariate logistic regression analysis. A nomogram based on these variables was developed and internally validated using 1000 bootstrap resamples.

RESULTS: A total of 562 cirrhotic patients with portal hypertension who underwent SED were included, and PVST occurred in 185 patients (32.9%). Multivariate logistic regression analysis showed that PVV was the strongest independent risk factor for PVST. The incidence of PVST was significantly higher in patients with PVV ≤ 16.5 cm/s than in those with PVV > 16.5 cm/s (76.2% vs. 8.5%, p < 0.0001). The PVV-based nomogram was internally validated and showed good performance (optimism-corrected c-statistic = 0.907). Decision curve and clinical impact curve analyses indicated that the nomogram provided a high clinical benefit.

CONCLUSION: A nomogram based on PVV provided an excellent preoperative prediction of PVST after splenectomy with esophagogastric devascularization.

PMID:38012440 | DOI:10.1007/s00464-023-10566-0

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Early outcomes of one-anastomosis gastric bypass in the elderly population at high-volume bariatric centers

Updates Surg. 2023 Nov 28. doi: 10.1007/s13304-023-01697-z. Online ahead of print.

ABSTRACT

The increasing rate of obesity and life expectancy will lead to increasing numbers of bariatric procedures in the elderly. We aim to report the early (≤ 30 days) adverse events of One-Anastomosis Gastric Bypass (OAGB) in this patient population. Assuta Bariatric Centers in Israel. Retrospective review of perioperative OAGB outcomes between elderly group (≥ 65 years) and non-elderly group (18-64 years) at high-volume bariatric centers between January 2017-December 2021. Operative time, length of stay (LOS), and overall ≤ 30 days complication rates, as ranked by the Clavien-Dindo Classification (CDC) were compared. There were 6618 patients (non-elderly group) and 104 (elderly group) who underwent OAGB. Gender and preoperative BMI were comparable between the two age groups. The elderly group had significantly higher rate of ischemic heart disease and chronic renal failure. The number of patients with LOS ≥ 3 days was significantly higher in the elderly group [19.4% (n = 20) vs. 6.6% (n = 331), respectively; p < 0.001]. The total early adverse events were higher in the elderly group with no statistical significance [7.7% (n = 8) vs. 3.8% (n = 250), respectively; p = 0.062]. The rate of minor and major adverse events and reoperation rate was comparable between the two groups. The rate of readmissions was significantly higher in the elderly group 5.8% (n = 6) vs. 1.9% (n = 124), respectively p = 0.015. There was 0.06% mortality (n = 2) in the non-elderly group. OAGB is a relatively safe metabolic and bariatric surgery for elderly obese patients with early (≤ 30 days) morbidity rates similar to the non-elderly population.

PMID:38012431 | DOI:10.1007/s13304-023-01697-z

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Does diet quality matter? A secondary analysis of a randomized clinical trial

Eur J Clin Nutr. 2023 Nov 28. doi: 10.1038/s41430-023-01371-y. Online ahead of print.

ABSTRACT

This secondary analysis assessed the association of a plant-based index (PDI), healthful (hPDI), and unhealthful (uPDI), with weight loss in overweight adults. Participants (n = 244) were randomly assigned to a vegan (n = 122) or control group (n = 122) for 16 weeks. Three-day dietary records were analyzed and PDI indices were calculated. A repeated measure ANOVA was used for statistical analysis. All three scores increased in the vegan group; the effect sizes were: PDI +10.6 (95% CI +8.6 to +12.6; p < 0.001); hPDI +10.9 (95% CI +8.4 to +13.4; p < 0.001); and uPDI +5.4 (95% CI +3.4 to +7.4; p < 0.001). The change in all three scores significantly correlated with change in body weight: PDI (r = -0.40; p < 0.001); hPDI (r = -0.37; p < 0.001); and uPDI (r = -0.21; p = 0.002). These findings suggest that minimizing the consumption of animal products and oil may be an effective weight loss strategy in overweight adults. ClinicalTrials.gov number, NCT02939638.

PMID:38012413 | DOI:10.1038/s41430-023-01371-y

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Complimentary Cardiac Computed Tomography Ventricular Volumetry-Derived Metrics of Severity in Patients with Ebstein Anomaly: Comparison with Echocardiography-Based Severity Indices

Pediatr Cardiol. 2023 Nov 28. doi: 10.1007/s00246-023-03342-3. Online ahead of print.

ABSTRACT

Detailed three-dimensional cardiac segmentations using cardiac computed tomography (CT) data is technically feasible in patients with Ebstein anomaly, but its complementary role has not been evaluated. This single-center, retrospective study was aimed to evaluate the complementary role of cardiac CT ventricular volumetry in evaluating the severity of Ebstein anomaly. Preoperative cardiac CT ventricular volumetry was performed in 21 children with Ebstein anomaly. CT-based ventricular functional measures were compared between Carpentier types, and between definitive surgical repair types. The Celermajer severity index measured with echocardiography was correlated with CT-based functional parameters. Total right ventricle (RV) and functional RV (fRV) volumes, fRV fraction, fRV/left ventricle (LV) volume ratio, and end-diastolic CT severity index demonstrated statistically significant differences between Carpentier type A/B and Carpentier type C/D (p < 0.05). The Celermajer severity index measured with echocardiography showed a high positive correlation with the end-diastolic CT severity index (R = 0.720, p < 0.002). There were no statistically significant differences in both echocardiography- and CT-based functional measures between patients with biventricular repair and patients with one-and-a-half or univentricular repair (p > 0.05). Compared with echocardiography, cardiac CT ventricular volumetry can provide the severity of Ebstein anomaly objectively and may be used in select patients when echocardiographic results are inconclusive or inconsistent.

PMID:38012401 | DOI:10.1007/s00246-023-03342-3

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Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: an extracted individual patient data and trial-level meta-analysis

Br J Cancer. 2023 Nov 27. doi: 10.1038/s41416-023-02501-w. Online ahead of print.

ABSTRACT

BACKGROUND: Neoadjuvant immunotherapy (nIO) has emerged as a treatment option for stage II-III triple-negative breast cancer (TNBC). While randomised clinical trials (RCTs) demonstrated pathological complete response rate benefit to nIO added to chemotherapy, additional data on long-term outcomes is warranted. We performed this analysis to evaluate long-term efficacy outcomes of nIO in TNBC.

METHODS: We searched databases for RCTs evaluating nIO in early-stage TNBC. A meta-analysis of extracted individual patient data (EIPD) was performed to evaluate EFS and OS, with data from reported Kaplan-Meier plots. Additionally, we conducted a trial-level meta-analysis using fixed and random effects models.

RESULTS: The literature search resulted in four included RCTs with available EFS or OS (KEYNOTE-522, IMpassion031, I-SPY2 and GeparNuevo). EIPD showed that the addition of nIO to chemotherapy provides statistically significant benefits in EFS (HR 0.62, 0.50-0.76; p < 0.001) and OS (HR 0.62, 0.46-0.82, p < 0.001). Number needed to treat to avoid one EFS or OS event in 4 years was 9 and 14, respectively. Trial-level meta-analysis yielded similar results (EFS: HR 0.64, 0.51-0.79; OS: 0.57, 0.37-0.89).

CONCLUSIONS: Results show that nIO combined with chemotherapy can provide significant EFS and OS benefits, supporting its use as standard treatment for early-stage TNBC.

PMID:38012381 | DOI:10.1038/s41416-023-02501-w

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Multilevel and subnational analysis of the predictors of maternity continuum of care completion in Nigeria: a cross-sectional survey

Sci Rep. 2023 Nov 27;13(1):20863. doi: 10.1038/s41598-023-48240-z.

ABSTRACT

Understanding population discrepancy in maternity continuum of care (CoC) completion, particularly in sub-Saharan Africa is significant for interventional plan to achieve optimal pregnancy outcome and child survival. This study thus investigated the magnitudes, distribution, and drivers of maternity CoC completion in Nigeria. A secondary analysis of 19,474 reproductive age (15-49 years) women with at least a birth (level 1) in 1400 communities (level 2) across 37 states covered in the 2018 cross-sectional survey. Stepwise regression initially identified important variables at 10% cutoff point. Multilevel analysis was performed to determine the likelihood and significance of individual and community factors. Intra-cluster correlation assessed the degree of clustering and deviance statistics identified the optimal model. Only 6.5% of the women completed the CoC. Completion rate is significantly different between communities “4.3% in urban and 2.2% in rural” (χ2 = 392.42, p < 0.001) and was higher in southern subnational than the north. Education (AOR = 1.61, 95% CI 1.20-2.16), wealth (AOR = 1.73, 95% CI 1.35-2.46), media exposure (AOR = 1.22, 95% CI 1.06-1.40), women deciding own health (AOR = 1.37, 95% CI 1.13-1.66), taking iron drug (AOR = 1.84, 95% CI 1.43-2.35) and at least 2 dose of tetanus-toxoid vaccine during pregnancy (AOR = 1.35, 95% CI 1.02-1.78) are associated individual factors. Rural residency (AOR = 1.84, 95% CI = 1.43-2.35), region (AOR = 1.84, 95% CI 1.43-2.35) and rural population proportion (AOR = 1.84, 95% CI 1.43-2.35) are community predictors of the CoC completion. About 63.2% of the total variation in CoC completion was explained by the community predictors. Magnitude of maternity CoC completion is generally low and below the recommended level in Nigeria. Completion rate in urban is twice rural and more likely in the southern than northern subnational. Women residence and region are harmful and beneficial community drivers respectively. Strengthening women health autonomy, sensitization, and education programs particularly in the rural north are essential to curtail the community disparity and optimize maternity CoC practice.

PMID:38012380 | DOI:10.1038/s41598-023-48240-z

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Truncated Weibull-exponential distribution: methods and applications

Sci Rep. 2023 Nov 27;13(1):20849. doi: 10.1038/s41598-023-48288-x.

ABSTRACT

This paper introduces a truncated Weibull-exponential distribution and provides a thorough insight into its mathematical characteristics. These characteristics include moments, generating functions, inverse distribution function, and entropy. Various measures are also discussed about the distribution’s reliability. A simulation study is carried out to assess the stability and consistency of the maximum likelihood estimates of the parameters. Finally, two social sciences data sets are used to assess the distribution’s relevance in modeling real-world situations.

PMID:38012379 | DOI:10.1038/s41598-023-48288-x

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Clinical, Bacterial, and Prosthodontic Parameters After Implant Abutment Disinfection Using Nd:YAG, Er,Cr:YSGG, Chlorhexidine, and Conventional Steam Before Prosthesis Delivery

Photobiomodul Photomed Laser Surg. 2023 Nov 27. doi: 10.1089/photob.2023.0076. Online ahead of print.

ABSTRACT

Objective: This 1-year prospective clinical trial was designed to assess the microbial, clinical, radiographic, and prosthetic parameters after disinfection of the implant abutment connection using Er,Cr:YSGG (erbium, chromium-doped: yttrium, scandium, gallium, and garnet) and Nd:YAG (neodymium-doped yttrium, aluminum, garnet). Materials and methods: All the patients were divided into four groups; Group I: Nd:YAG laser, Group II: Er,Cr:YSGG laser, Group III: 0.2% chlorhexidine (CHx), and Group IV: steam disinfection. Peri-implant parameters assessed included peri-implant bleeding scores (PIBS), peri-implant plaque scores (PIPS), peri-implant pocket depth (PIPD), and crestal bone loss (CBL). The peri-implant plaque samples were acquired to perform microbiological analysis to assess Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia, respectively. All measurements were completed at baseline, 6 months, and 12 months postsurgery. Multiple groups were compared with the help of the Bonferroni post-hoc adjustment test (p < 0.01). Logistic regression models were utilized to assess the association between age, oral hygiene practices (brushing and flossing), and duration of implant function. Results: At the baseline level, there were no discernible differences in the peri-implant parameters between the study groups (p > 0.05). At the 6-month (p < 0.01) and 12-month (p < 0.001) follow-ups, all four study groups demonstrated a significant improvement in PIPS and PIBS, with no significant differences between the groups at baseline (p > 0.05). Based on an intergroup comparison, Group I (Nd:YAG) showed a significant decrease in PIBS when compared with the other groups. Group II showed a considerable decrease in PIPD and enhancements in CBL when compared with Groups I, III, and IV (p < 0.01). At the 6- and 12-month follow-up periods, P. gingivalis and T. denticola reduction were found to be statistically higher in Group II, whereas P. gingivalis and T. forsythia mean log CFU/mL were found to be statistically higher in Group I. Conclusions: Nd:YAG and Er,Cr:YSGG lasers both outperformed CHx and steam disinfection in terms of clinical, peri-implant, and prosthetic results when used to clean implant abutments.

PMID:38011738 | DOI:10.1089/photob.2023.0076

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Comparison of cervical fusion with autografting of fibula vs titanium cage

Rev Med Inst Mex Seguro Soc. 2023 Sep 18;61(Suppl 2):S193-S199.

ABSTRACT

BACKGROUND: The anterior cervical discectomy and fusion (ACDF) is the gold standard in the treatment of cervical compression pathology and the titanium cage for fusion represents the most used procedure at an institutional level. A technique using fibular autograft has been described, with good results, lower morbidity and lower cost.

OBJECTIVE: To compare the rate of fusion, subsidence and functional clinical results after discectomy with titanium cage and fibular autograft.

MATERIAL AND METHODS: A clinical trial with follow-up at 3 and 6 months was carried out in patients diagnosed with cervical spondylosis, candidates for ACDF. 2 groups were formed: fibular autograft and titanium cage. Pre and post functional evaluation using the cervical disability score was made, as well as radiographic fusion and subsidence evaluation. Descriptive statistics, Fisher’s exact test, t-test and ANOVA were obtained, establishing p < 0.05.

RESULTS: A sample of 20 patients with an average age of 56 years was obtained, finding a fusion rate of 90% for fibular autograft and 30% for titanium (p = 0.02) at 3 months. 10% of patients with fibular autograft presented subsidence and 70% with titanium cage at 3 and 6 months (p = 0.02). In the functional results was not found difference between both procedures (p = 0.874).

CONCLUSIONS: The use of autologous fibular graft offers a better rate of fusion and subsidence compared to the titanium cage, as well as similar functional results at 3 months of follow-up. It represents an excellent treatment option for cervical spondylosis.

PMID:38011687