A Randomized Clinical Trial

[Posted 9/Nov/2022]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: Results of this trial showed that, compared with propofol, etomidate anesthesia did not increase overall major in-hospital morbidity after abdominal surgery in older patients, although it induced transient adrenocortical suppression.

BACKGROUND: Aim of this study is to test the primary hypothesis that etomidate vs propofol for anesthesia does not increase in-hospital morbidity after abdominal surgery in older patients.

DETAILS: This multicenter, parallel-group, noninferiority randomized clinical trial (Etomidate vs Propofol for In-hospital Complications [EPIC]) was conducted between August 15, 2017, and November 20, 2020, at 22 tertiary hospitals in China. Participants were aged 65 to 80 years and were scheduled for elective abdominal surgery. Patients and outcome assessors were blinded to group allocation. Data analysis followed a modified intention-to-treat principle. Primary outcome was a composite of major in-hospital postoperative complications (with a noninferiority margin of 3%). Secondary outcomes included intraoperative hemodynamic measurements; postoperative adrenocortical hormone levels; self-reported postoperative pain, nausea, and vomiting; and mortality at postoperative months 6 and 12. A total of 1944 participants were randomized, of whom 1917 (98.6%) completed the trial. Patients were randomized to the etomidate group (n = 967; mean [SD] age, 70.3 [4.0] years; 578 men [59.8%]) or propofol group (n = 950; mean [SD] age, 70.6 [4.2] years; 533 men [56.1%]). The primary end point occurred in 90 of 967 patients (9.3%) in the etomidate group and 83 of 950 patients (8.7%) in the propofol group, which met the noninferiority criterion (risk difference [RD], 0.6%; 95% CI, -1.6% to 2.7%; P = .66). In the etomidate group, mean (SD) cortisol levels were lower at the end of surgery (4.8 [2.7] µg/dL vs 6.1 [3.4] µg/dL; P < .001), and mean (SD) aldosterone levels were lower at the end of surgery (0.13 [0.05] ng/dL vs 0.15 [0.07] ng/dL; P = .02) and on postoperative day 1 (0.14 [0.04] ng/dL vs 0.16 [0.06] ng/dL; P = .001) compared with the propofol group. No difference in mortality was observed between the etomidate and propofol groups at postoperative month 6 (2.2% vs 3.0%; RD, -0.8%; 95% CI, -2.2% to 0.7%) and 12 (3.3% vs 3.9%; RD, -0.6%; 95% CI, -2.3% to 1.0%). More patients had pneumonia in the etomidate group than in the propofol group (2.0% vs 0.3%; RD, 1.7%; 95% CI, 0.7% to 2.8%; P = .001). Results were consistent in the per-protocol population.

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Source: Lu, Z., Zheng, H., Chen, Z., et al. (2022). Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. Lasers Surg. Med.. 2022; 157(10): 888-895. Published: October, 2022. DOI: 10.1001/jamasurg.2022.3338.

A Real-World Clinical Study of 126 Patients

[Posted 19/Mar/2024]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: FMR is a safe and effective treatment modality for improving facial atrophic acne scars, and the number of FMR treatment sessions and pulse width are associated with clinical efficacy.

BACKGROUND: Purpose of this study is to analyze the clinical efficacy and safety of fractional microneedle radiofrequency (FMR) for facial atrophic acne scars in a real-world setting.

DETAILS: The clinical data of patients with atrophic acne scars who had received FMR therapy from February 2018 to August 2022 were retrospectively analyzed. The improvement of atrophic acne scars was assessed using the ECCA Grading Scale (échelle d'évaluation clinique des cicatrices d'acné), Global Aesthetic Improvement Scale (GAIS), and modified Manchester Scar Scale (mMSS). Adverse reactions during FMR treatment were also recorded. Univariate and multivariate logistic regression analyses were performed to evaluate the efficacy and safety of FMR for atrophic acne scars. A total of 126 patients with facial atrophic acne scars were included. A total of 590 FMR treatment sessions were accomplished, with each of 82 patients receiving 4 or more treatment sessions, and 1 receiving a maximum of 14 sessions. All patients showed improvement in symptoms after FMR treatment, with moderate to significant improvement (ECCA score reduction of 26%–100%) in 92 (73.0%) patients. As the number of treatment sessions increased, the ECCA score gradually decreased from an average of 85.6 before to 35.0 after FMR. The average scores for distortion, color, and visual analogue scale (VAS) of mMSS all showed certain reductions. The change in GAIS score indicated improvement after treatment, with minimal improvement in 16 patients (12.7%), good improvement in 57 patients (45.2%), significant improvement in 45 patients (35.7%), and optimal improvement in 8 patients (6.4%). The univariate and multivariate logistic regression analyses revealed that the long pulse width and the number of FMR treatment sessions were positively associated with clinical efficacy. Compared to the short pulse-width group (200 ms), the longer pulse-width group (300 ms) (odds ratio [OR] = 8.3, p = 0.003) and the even longer pulse-width group (400–500 ms) (OR = 52.6, p 0.001) demonstrated stronger efficacies. Patients who received more than three treatment sessions had better outcomes compared to those who received three or fewer treatment sessions (OR = 4.0, p = 0.036). All patients experienced posttreatment transient erythema, but no crusting, infection, or blister. Six cases developed grid-like erythema around 1 month posttreatment and one case experienced hyperpigmentation, both of which resolved within 1–3 months after appropriate management.

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Source: Ziwei, D., Yuan, G., Yuehong, G., et al. (2024). Efficacy and Safety of Fractional Microneedle Radiofrequency for Atrophic Acne Scars: A Real-World Clinical Study of 126 Patients. Lasers Surg. Med.. 2024; 56(2): 150-164. Published: February, 2024. DOI: 10.1002/lsm.23759.

A Comparative Study

[Posted 18/Jan/2024]

AUDIENCE: General Surgery

KEY FINDINGS: Bone-cutting mechanism and the biological influence of the laser beam and ultrasound on living tissues proved to be favorable factors for patients' pain levels and tissue swelling postoperatively independent of the longer osteotomy duration compared to conventional drilling.

BACKGROUND: There are few research works with in-depth studies and direct simultaneous comparisons of the effects on tissue reactions and patients' recovery following in vivo conventional drilling, ultrasound- and laser-assisted osteotomy in humans. The current study aims to compare bone cutting duration, pain, swelling, and trismus in patients following surgical mandible third molar extraction by bone removal using three different osteotomes-a conventional rotary device, an ultrasonic unit, and an Er:YAG laser.

DETAILS: A prospective, randomized three-group comparative clinical trial was performed. As an experimental setting for the study, an open mandible third molar surgery was chosen because osteotomy is included in its protocol. Patients were divided into three groups according to the used device for bone removal. Bone cutting time intraoperatively, facial swelling, trismus, and pain on the first, second, and third postoperative days were assessed. The statistical analyses were performed using the SPSS v. 17.0-Kolmogorov-Smirnov test, one-way ANOVA, Student's t-test, Mann-Whitney test, and x² test. Statistical results were considered significant at p < 0.05 (confidence interval of difference, 95% CI). Eighty patients (34 males and 46 females with an average age of 25.18 years) were included in the study. The average time for bone removal by the conventional low-speed device (4.95 min), by the ultrasonic unit (5.13 min), and by the Er:YAG laser (9.00 min) differed significantly (p = 0.001). The mean postoperative facial swelling showed a marked difference between the groups (p < 0.05), in favor of the laser and piezo groups. The osteotome proved to influence pain intensity not only immediately after surgery (p = 0.002), but also during the followed-up period (p = 0.001), again in favor of the two above-mentioned groups. No association was found between trismus and the osteotome used by the followed-up patients (p > 0.05).

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Source: Blagova, B., Krastev, D., and Malinova, L. (2023). Conventional Drilling Versus Ultrasound and Laser Osteotomy in Mandibular Third Molar Surgery: A Comparative Study. Lasers in Surgery and Medicine. 2023; 55(10): 862-870. Published: December, 2023. DOI: 10.1002/lsm.23730.

[Posted 24/Aug/2023]

AUDIENCE: General Surgery, Internal Medicine

KEY FINDINGS: Compared to conventional ICS, NMP can significantly reduce the incidence of EAD, RPS, and IC after DCD liver transplantation.

BACKGROUND: In this study, authors sought to assess how liver allografts preserved using portable normothermic machine perfusion (NMP) compare against those that underwent ischemic cold storage (ICS) in the setting of donation after brain death (DBD) and donation after circulatory death (DCD) liver transplantation. Compared to conventional ICS, NMP may offer a more homeostatic preservation, permit physiologic assessment of organ function, and provide opportunities for graft improvement/modification. We report a single center US experience of liver NMP.

DETAILS: A single center, retrospective analysis of collected data on 541 adult whole liver transplants from 469 DBD donors (NMP[n=58] vs ICS[n=411]) and 72 DCD donors (NMP[n=52] vs ICS[n=20]) between January 2016 and December 2022. In DBD LT, male gender (OR [95% CI]: 1.83 [1.08-3.09]) and greater than 10% macrosteatosis of the donor liver (1.85 [1.10-3.10]) were statistically significant independent risk factors of early allograft dysfunction (EAD). Donor age >40yo and cold ischemia time (CIT) >7h were independent risk factors of reperfusion syndrome (RPS). 1-year, 3-year, and 5-year incidences of ischemic cholangiopathy (IC) did not differ significantly in DBD cases between the NMP and ICS cohorts. In DCD LT, NMP was an independent protective factor against EAD (0.11 [0.03-0.46]) and RPS (0.04 [0.01-0.25]). Incidence of IC in the DCD cases at 1-year and 3-year timepoints was significantly lower in the NMP cohort (1.9% compared to 20% in the ICS group).

Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Source: Yamamoto, T., Atthota, S., Agarwal, D., et al. (2023). Impact of Portable Normothermic Machine Perfusion for Liver Transplantation From Adult Deceased Donors. Annals of Surgery . Published: August, 2023. DOI: 10.1097/SLA.0000000000006032.

[Posted 28/Jul/2023]

AUDIENCE: Ob/Gyn, Oncology

KEY FINDINGS: Reflexing samples with intermediate OVA1 scores significantly decreases the false-positive rate, thereby reducing unnecessary surgical referrals.

BACKGROUND: Patients with adnexal masses suspicious for malignancy benefit from referral to oncology specialists during presurgical assessment of the mass. OVA1 is a multivariate assay using a five-biomarker panel which offers high overall and early-stage sensitivity. However, OVA1 has a high false-positive rate for benign masses. Overa, a second-generation multivariate index assay was developed to reduce the false-positive rate. The aim of the present study was to use Overa as a reflex for OVA1 and increase specificity.

DETAILS: OVA1 cut-off scores were established to place patients into three categories: low, intermediate, and high cancer risk. Samples with intermediate-risk OVA1 scores were reflexed to the Overa and defined as high or low risk. This protocol was tested with 1035 prospectively collected serum samples and validated with an independent prospectively collected sample set (N = 207). Thirty-five per cent (359) of samples had intermediate OVA1 scores. Reflexing these to Overa eliminated 58% of the false-positives and improved the overall specificity from 50% to 72%. This finding was confirmed in the independent dataset, in which the specificity increased from 56% to 73%.

Copyright © John Wiley & Sons, Inc. All rights reserved

Source: Fritsche, H. A. and Bullock, R. G. (2023). A Reflex Testing Protocol Using Two Multivariate Index Assays Improves the Risk Assessment for Ovarian Cancer in Patients With an Adnexal Mass. Intl J Gynecol Obstet.. 2023; 162(2): 485-492. Published: August, 2023. DOI: 10.1002/ijgo.14733.

[Posted 24/Jul/2023]

AUDIENCE: General Surgery, Oncology

KEY FINDINGS: Time intervals longer than 12 weeks were associated with improved TRG and systemic recurrence but may increase surgical complexity and minor morbidity.

BACKGROUND: The treatment for extraperitoneal locally advanced rectal cancer (LARC) is neoadjuvant therapy (NAT) followed by total mesorectal excision (TME). Robust evidence on the optimal time interval between NAT completion and surgery is lacking. Purpose of this study is to assess the association of time interval between NAT completion and TME with short- and long-term outcomes. It was hypothesized that longer intervals increase the pathologic complete response (pCR) rate without increasing perioperative morbidity.

DETAILS: This cohort study included patients with LARC from 6 referral centers who completed NAT and underwent TME between January 2005 and December 2020. The cohort was divided into 3 groups depending on the time interval between NAT completion and surgery: short (<=8 weeks), intermediate (>8 and <=12 weeks), and long (>12 weeks). The median follow-up duration was 33 months. Data analyses were conducted from May 1, 2021, to May 31, 2022. The inverse probability of treatment weighting method was used to homogenize the analysis groups. The primary outcome was pCR. Other histopathologic results, perioperative events, and survival outcomes constituted the secondary outcomes. Among the 1506 patients, 908 were male (60.3%), and the median (IQR) age was 68.8 (59.4-76.5) years. The short-, intermediate-, and long-interval groups included 511 patients (33.9%), 797 patients (52.9%), and 198 patients (13.1%), respectively. The overall pCR was 17.2% (259 of 1506 patients; 95% CI, 15.4%-19.2%). When compared with the intermediate-interval group, no association was observed between time intervals and pCR in short-interval (odds ratio [OR], 0.74; 95% CI, 0.55-1.01) and long-interval (OR, 1.07; 95% CI, 0.73-1.61) groups. The long-interval group was significantly associated with lower risk of bad response (tumor regression grade [TRG] 2-3; OR, 0.47; 95% CI, 0.24-0.91), systemic recurrence (hazard ratio, 0.59; 95% CI, 0.36-0.96), higher conversion risk (OR, 3.14; 95% CI, 1.62-6.07), minor postoperative complications (OR, 1.43; 95% CI, 1.04-1.97), and incomplete mesorectum (OR, 1.89; 95% CI, 1.02-3.50) when compared with the intermediate-interval group.

Copyright © American Medical Association. All Rights Reserved.

Source: Guzman, Y., Rios, J., Paredes, J., et al. (2023). Time Interval Between the End of Neoadjuvant Therapy and Elective Resection of Locally Advanced Rectal Cancer in the CRONOS Study. JAMA Surgery. Published: July, 2023. DOI: 10.1001/jamasurg.2023.2521.