Ameliorating effect of olive oil on fertility of male rats fed on genetically modified soya bean

Background: Genetically modified soya bean (GMSB) is a commercialized food. It has been shown to have adverse effects on fertility in animal trials. Extra virgin olive oil (EVOO) has many beneficial effects including anti-oxidant properties. The aim of this study is to elucidate if addition of EVOO ameliorates the adverse effects on reproductive organs of rats fed on GMSB containing diet. Methods: Forty adult male albino rats (150–180 g) of Sprague Dawley strain were separated into four groups of 10 rats each: Group 1 – control group fed on basal ration, Group 2 – fed on basal ration mixed with EVOO (30%), Group 3 – fed on basal ration mixed with GMSB (15%), and Group 4 – fed on basal ration mixed with GMSB (15%) and EVOO (30%). This feeding regimen was administered for 65 days. Blood samples were collected to analyze serum zinc, vitamin E, and testosterone levels. Histopathological and weight changes in sex organs were evaluated. Results: GMSB diet reduced weight of testis (0.66±0.06 vs. 1.7±0.06, p<0.001), epididymis (0.489±0.03 vs. 0.7±0.03, p<0.001), prostate (0.04±0.009 vs. 0.68±0.04, p<0.001), and seminal vesicles (0.057±0.01 vs. 0.8±0.04, p<0.001). GMSB diet adversely affected sperm count (406±7.1 vs. 610±7.8, p<0.001), motility (p<0.001), and abnormality (p<0.001). GMSB diet also reduced serum zinc (p<0.05), vitamin E (p<0.05), and testosterone (p<0.05) concentrations. EVOO diet had no detrimental effect. Addition of EVOO to GMSB diet increased the serum zinc (p<0.05), vitamin E (p<0.05), and testosterone (p<0.05) levels and also restored the weights of testis (1.35±0.16 vs. 0.66±0.06, p<0.01), epididymis (0.614±0.13 vs. 0.489±0.03, p<0.001), prostate (0.291±0.09 vs. 0.04±0.009, p<0.001), seminal vesicle (0.516±0.18 vs. 0.057±0.01, p<0.001) along with sperm count (516±3.1 vs. 406±7.1, p<0.01), motility (p<0.01), and abnormality (p<0.05). Conclusion: EVOO ameliorates the adverse effects of GMSB on reproductive organs in adult male albino rats. This protective action of EVOO justifies its use against the oxidative damage induced by GMSB in reproductive organs

The Factor structure of the Rosenberg Self-Esteem Scale among school students and university students in Oman

هدفت الدراسة الحالية إلى اختبار البنية العاملية لمقياس روزنبرغ لتقدير الذات، وفحص ما إذا كانت هذه البنية تتساوى لدى عينتين عمريتين. فقد أفادت دراسات عدة أن تقدير الذات ينمو ويتطور ويصبح أكثر واقعية وتمايزًا مع التقدم في العمر. وقد استجاب لمقياس تقدير الذات 365 طالبًا من طلبة المدارس و119 من طلبة الجامعة. يتكون مقياس تقدير الذات لروزنبرغ من 10 فقرات، نصفها تمت صياغته صياغة موجبة، والنصف الآخر تمت صياغته صياغة سالبة. وقد تبين أن مقياس تقدير الذات يتمتع بثبات مقبول لا سيما لدى طلبة الجامعة. وقد تبين أن المقياس يتمتع ببنية عاملية مقبولة لدى كل من العينتين، فقد تشبعت كل فقرات المقياس على عامل تقدير الذات بدرجة جوهرية. إلا أن وجود عامل واحد فقط؛ لم يمثل البيانات بشكل مقبول، فقد كان التطابق ضعيفًا بين العامل الواحد والبيانات. في حين أن وجود عاملين أحدهما موجب والآخر سالب، مثّلا البيانات بدرجة معقولة. ولكن عند اختبار فرضية تساوي المعالم لدى العينتين، اتضح أن المعالم التي تمثل التشبعات كانت متساوية لدى المجموعتين، بينما لم تتساو معالم الثوابت والبواقي والعلاقات بين البواقي. وخلصت الدراسة إلى أن النموذج الأكثر مطابقة للبيانات هو نموذج عامل السمة وعامل الطريقة السالبة في الصياغة، في إشارة إلى تأثير طريقة الصياغة على البنية العاملية، والدرجة التي يفرزها مقياس روزنبرغ. كما تبين الدراسة أهمية الانتباه إلى طريقة صياغة الفقرات عند تفسير الدرجات التي يفرزها هذا المقياس وغيره من المقاييس التي تحوي عبارات موجبة وأخرى سالبة.The aim of this study was to test the structure of Rosenberg Self-Esteem Scale (RSES) and explore if the structure is invariant across school students (n=365) and university students (n=119). Previous research has shown that self-esteem so as other personality traits are developmental in nature; and self-esteem becomes more differentiated and realistic with age. Two samples responded to RSES which has 10 items half of which was written in the positive format and the other half in negative format. RSES showed reasonable internal consistency, especially among university students. Also, the scale produced a reasonable structure among both groups as the items measured the factor substantially. Item loadings were invariant across the two groups. However, other parameters (intercepts, residuals and correlations among residuals) were not invariant indicating that the items measured the trait equally valid for school and university students. However, the level of self-esteem as indicated by item scores was not invariant as school children scored higher than university students in most of the items. The results imply that using negative items has an effect on both the structure and magnitude of self-esteem. Scale developers and users may need to be cautioned when they interpret the resultant scores of scales with positive and negative items

Global Survey on Pancreatic Surgery During the COVID-19 Pandemic

This global survey among members of seven international pancreatic associations and study groups elucidates the role of pancreatic surgery during the COVID-19 pandemic, regarding patient selection for the surgical and oncological treatment of pancreatic diseases to support clinical decision-making and creating a starting point for further discussion

Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2):study protocol for an international multicenter patient-blinded randomized controlled trial

Background: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration: ISRCTN27483786. Registered on August 2, 2023.</p

Minimally invasive spleen-preserving distal pancreatectomy: real-world data from the italian national registry of minimally invasive pancreatic surgery

Aim: Minimally invasive distal pancreatectomy has become the standard of care for benign and low malignant lesions. Spleen preservation in this setting has been proposed to reduce surgical trauma and long-term sequelae. The aim of the current study is to present real-world data on indications, techniques, and outcomes of spleen-preserving distal pancreatectomy (SPDP). Methods: Patients who underwent SPDP and distal pancreatectomy with splenectomy (DPWS) were extracted from the 2019-2022 Italian National Registry for Minimally Invasive Pancreatic Surgery (IGoMIPS). Perioperative and pathological data were collected. Results: One hundred and ten patients underwent SPDP and five hundred and seventy-eight underwent DPWS. Patients undergoing SPDP were significantly younger (56 vs. 63.5 years; P &lt; 0.001). Seventy-six percent of SPDP cases were performed in six out of thirty-four IGoMIPS centers. SPDP was performed predominantly for Neuroendocrine Tumors (43.6% vs.23.5%; P &lt; 0.001) and for smaller lesions (T1 57.6% vs. 29.8%; P &lt; 0.001). The conversion rate was higher in the case of DPWS (7.6% vs. 0.9%; P = 0.006), even when pancreatic cancer was ruled out (5.0% vs. 0.9%; P = 0.045). The robotic approach was most commonly used for SPDP (50.9% vs. 29.7%; P &lt; 0.001). No difference in postoperative outcomes and length of stay was observed between the two groups, as well as between robotic and laparoscopic approaches in the SPDP group. A trend toward a lower rate of postoperative sepsis was observed after SPDP (0.9% vs. 5.2%; P = 0.056). In 84.7% of SPDP, splenic vessels were preserved (Kimura procedure) without an impact on short-term postoperative outcomes. Conclusion: In this registry analysis, SPDP was feasible and safe. The Kimura procedure was prevalent over the Warshaw procedure. The typical patient undergoing SPDP was young with a neuroendocrine tumor at an early stage. Robotic assistance was used more frequently for SPDP than for DPWS

Minimally invasive versus open distal pancreatectomy: an individual patient data meta-analysis of two randomized controlled trials

Background: Minimally invasive distal pancreatectomy (MIDP) has been suggested to reduce postoperative outcomes as compared to open distal pancreatectomy (ODP). Recently, the first randomized controlled trials (RCTs) comparing MIDP to ODP were published. This individual patient data meta-analysis compared outcomes after MIDP versus ODP combining data from both RCTs. Methods: A systematic literature search was performed to identify RCTs on MIDP vs. ODP, and individual patient data were harmonized. Primary endpoint was the rate of major (Clavien-Dindo ≥ III) complications. Sensitivity analyses were performed in high-risk subgroups. Results: A total of 166 patients from the LEOPARD and LAPOP RCTs were included. The rate of major complications was 21% after MIDP vs. 35% after ODP (adjusted odds ratio 0.54; p = 0.148). MIDP significantly reduced length of hospital stay (6 vs. 8 days, p = 0.036), and delayed gastric emptying (4% vs. 16%, p = 0.049), as compared to ODP. A trend towards higher rates of postoperative pancreatic fistula was observed after MIDP (36% vs. 28%, p = 0.067). Outcomes were comparable in high-risk subgroups. Conclusion: This individual patient data meta-analysis showed that MIDP, when performed by trained surgeons, may be regarded as the preferred approach for distal pancreatectomy. Outcomes are improved after MIDP as compared to ODP, without obvious downsides in high-risk subgroups

Implementation and outcome of minimally invasive pancreatoduodenectomy in Europe:a registry-based retrospective study A critical appraisal of the first 3 years of the E-MIPS registry

BACKGROUND: International multicenter audit-based studies focusing on the outcome of minimally invasive pancreatoduodenectomy (MIPD) are lacking. The European Registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is the E-AHPBA endorsed registry aimed to monitor and safeguard the introduction of MIPD in Europe. MATERIALS AND METHODS: A planned analysis of outcomes among consecutive patients after MIPD from 45 centers in 14 European countries in the E-MIPS registry (2019-2021). The main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality. RESULTS: Overall, 1336 patients after MIPD were included [835 robot-assisted (R-MIPD) and 501 laparoscopic MIPD (L-MIPD)]. Overall, 20 centers performed R-MIPD, 15 centers L-MIPD, and 10 centers both. Between 2019 and 2021, the rate of centers performing L-MIPD decreased from 46.9 to 25%, whereas for R-MIPD this increased from 46.9 to 65.6%. Overall, the rate of major morbidity was 41.2%, 30-day/in-hospital mortality 4.5%, conversion rate 9.7%, postoperative pancreatic fistula grade B/C 22.7%, and postpancreatectomy hemorrhage grade B/C 10.8%. Median length of hospital stay was 12 days (IQR 8-21). A lower rate of major morbidity, postoperative pancreatic fistula grade B/C, postpancreatectomy hemorrhage grade B/C, delayed gastric emptying grade B/C, percutaneous drainage, and readmission was found after L-MIPD. The number of centers meeting the Miami Guidelines volume cut-off of ≥20 MIPDs annually increased from 9 (28.1%) in 2019 to 12 (37.5%) in 2021 ( P =0.424). Rates of conversion (7.4 vs. 14.8% P &lt;0.001) and reoperation (8.9 vs. 15.1% P &lt;0.001) were lower in centers, which fulfilled the Miami volume cut-off. CONCLUSION: During the first 3 years of the pan-European E-MIPS registry, morbidity and mortality rates after MIPD were acceptable. A shift is ongoing from L-MIPD to R-MIPD. Variations in outcomes between the two minimally invasive approaches and the impact of the volume cut-off should be further evaluated over a longer time period.</p

Multisocietal European consensus on the terminology, diagnosis, and management of patients with synchronous colorectal cancer and liver metastases:an E-AHPBA consensus in partnership with ESSO, ESCP, ESGAR, and CIRSE

BACKGROUND: Contemporary management of patients with synchronous colorectal cancer and liver metastases is complex. The aim of this project was to provide a practical framework for care of patients with synchronous colorectal cancer and liver metastases, with a focus on terminology, diagnosis, and management. METHODS: This project was a multiorganizational, multidisciplinary consensus. The consensus group produced statements which focused on terminology, diagnosis, and management. Statements were refined during an online Delphi process, and those with 70 per cent agreement or above were reviewed at a final meeting. Iterations of the report were shared by electronic mail to arrive at a final agreed document comprising 12 key statements.RESULTS: Synchronous liver metastases are those detected at the time of presentation of the primary tumour. The term 'early metachronous metastases' applies to those absent at presentation but detected within 12 months of diagnosis of the primary tumour, the term 'late metachronous metastases' applies to those detected after 12 months. 'Disappearing metastases' applies to lesions that are no longer detectable on MRI after systemic chemotherapy. Guidance was provided on the recommended composition of tumour boards, and clinical assessment in emergency and elective settings. The consensus focused on treatment pathways, including systemic chemotherapy, synchronous surgery, and the staged approach with either colorectal or liver-directed surgery as first step. Management of pulmonary metastases and the role of minimally invasive surgery was discussed. CONCLUSION: The recommendations of this contemporary consensus provide information of practical value to clinicians managing patients with synchronous colorectal cancer and liver metastases.</p

Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA):an international randomised non-inferiority trial

Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson &amp; Johnson Medical Limited, Dutch Gastroenterology Society.</p

Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA):an international randomised non-inferiority trial

Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson &amp; Johnson Medical Limited, Dutch Gastroenterology Society.</p