Results Of Prospective Observational Study Research Articles

Ibalizumab’s Role in Multidrug-Resistant HIV

Although treatment for HIV has advanced considerably over the decades, there are still people with HIV that is resistant to multiple antiretroviral therapies (ART). Ibalizumab, a humanized IgG4 monoclonal antibody that gained orphan status in 2018, is a post-attachment inhibitor whose efficacy for people with multidrug-resistant (MDR) HIV has been demonstrated in Phase II and III trials. The Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) is an ongoing study that will investigate long-term efficacy and durability of ibalizumab plus an optimized background regimen (OBR). In the poster discussed here, presented at IDWeek 2024, examination of baseline demographics showed that individuals prescribed ibalizumab (IBA group) had similar mean age, sex, race, and duration since diagnosis of HIV to those on regimens that did not include ibalizumab (non-IBA group). However, mean baseline HIV RNA copies/mL were much higher and CD4+ T cells/mm3 lower in the IBA group compared with the non-IBA group, and highest/lowest at baseline in a subset of IBA group patients who were also prescribed the capsid inhibitor lenacapavir. OBR also differed between groups. These results highlight the HIV-related characteristics of individuals who are more likely to be prescribed ibalizumab.

A Prospective Observational Study of Maternal, Fetal and Neonatal Outcome in Singleton Term Pregnancies With Amniotic Fluid Index Between 5-8cm"

A Prospective Observational Study of Maternal, Fetal and Neonatal Outcome in Singleton Term Pregnancies With Amniotic Fluid Index Between 5-8cm"

Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes.

Trastuzumab has had a major impact on the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). Anti-HER2 biosimilars such as Ogivri have demonstrated safety and clinical equivalence to trastuzumab (using Herceptin as the reference product) in clinical trials. To our knowledge, there has been no real-world report of the side effects and quality of life (QoL) in patients treated with biosimilars using electronic patient-reported outcomes (ePROs). The primary objective of this prospective observational study (OGIPRO study) was to compare the ePRO data related to treatment side effects collected with the medidux app in patients with HER2-positive BC treated with the trastuzumab biosimilar Ogivri (prospective cohort) to those obtained from historical cohorts treated with Herceptin alone or combined with pertuzumab and/or chemotherapy (ClinicalTrials.gov NCT02004496 and NCT03578731). Patients were treated with Ogivri alone or combined with pertuzumab and/or chemotherapy and hormone therapy in (neo)adjuvant and palliative settings. Patients used the medidux app to dynamically record symptoms (according to the Common Terminology Criteria for Adverse Events [CTCAE]), well-being (according to the Eastern Cooperative Oncology Group Performance Status scale), QoL (using the EQ-5D-5L questionnaire), cognitive capabilities, and vital parameters over 6 weeks. The primary endpoint was the mean CTCAE score. Key secondary endpoints included the mean well-being score. Data of this prospective cohort were compared with those of the historical cohorts (n=38 patients; median age 51, range 31-78 years). Overall, 53 female patients with a median age of 54 years (range 31-87 years) were enrolled in the OGIPRO study. The mean CTCAE score was analyzed in 50 patients with available data on symptoms, while the mean well-being score was evaluated in 52 patients with available data. The most common symptoms reported in both cohorts included fatigue, taste disorder, nausea, diarrhea, dry mucosa, joint discomfort, tingling, sleep disorder, headache, and appetite loss. Most patients experienced minimal (grade 0) or mild (grade 1) toxicities in both cohorts. The mean CTCAE score was comparable between the prospective and historical cohorts (29.0 and 30.3, respectively; mean difference -1.27, 95% CI -7.24 to 4.70; P=.68). Similarly, no significant difference was found for the mean well-being score between the groups treated with the trastuzumab biosimilar Ogivri and Herceptin (74.3 and 69.8, respectively; mean difference 4.45, 95% CI -3.53 to 12.44; P=.28). Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds. ClinicalTrials.gov NCT05234021; https://clinicaltrials.gov/study/NCT05234021.

A Prospective Observational Study of Patient Related Outcome of Post Hysterectomized Females

Background: Women who had undergone hysterectomy have to overcome problems related to physical, social and emotional well being. As the hysterectomy is one of the most common surgeries, a study was conducted to answer the question for the optimal surgical recovery. This study aims to describe the relationships between recovery time and the components of quality of life after hysterectomy. Aims and Objectives: To study the physical, social, and emotional well being of post hysterectomised patient. Methodology: Study was conducted in Department of Obstetrics and Gynaecology at Bharati hospital, Pune. It was a prospective observational study of patient related outcomes to study the physical, social, and emotional well being of post hysterectomised patient. Post hysterectomized women above 40 years were included in this study. 196 post hysterectomised women were included. Study was conducted from October 2021 to January 2024. Results: From third month onwards, degree of difficulty of majority of patients was reduced in all mentioned activities. Majority of cases there was gradual health improvement noted. The pain score was reduced over 3 months in 92% cases and in almost all patients over 6 months. Conclusion: It is important to assess quality of life after any surgery, so timely intervention suchasphysiotherapy, counselling,psychotherapy and medical therapy canaidin improvement of both physical and emotional health for betterment of patient care.

Protracted fibrinolysis resistance following cardiac surgery with cardiopulmonary bypass: A prospective observational study of clinical associations and patient outcomes.

Surgery on cardiopulmonary bypass (CPB) elicits a pleiomorphic systemic host response which, when severe, requires prolonged intensive care support. Given the substantial cross-talk between inflammation, coagulation, and fibrinolysis, the aim of this hypothesis-generating observational study was to document the kinetics of fibrinolysis recovery post-CPB using ClotPro® point-of-care viscoelastometry. Tissue plasminogen activator-induced clot lysis time (TPA LT, s) was correlated with surgical risk, disease severity, organ dysfunction and intensive care length of stay (ICU LOS). In 52 patients following CPB, TPA LT measured on the first post-operative day (D1) correlated with surgical risk (EuroScore II, Spearman's rho .39, p < .01), time on CPB (rho = .35, p = .04), disease severity (APACHE II, rho = .52, p < .001) and organ dysfunction (SOFA, rho = .51, p < .001) scores, duration of invasive ventilation (rho = .46, p < .01), and renal function (eGFR, rho = -.65, p < .001). In a generalized linear regression model containing TPA LT, CPB run time and markers of organ function, only TPA LT was independently associated with the ICU LOS (odds ratio 1.03 [95% CI 1.01-1.05], p = .01). In a latent variables analysis, the association between TPA LT and the ICU LOS was not mediated by renal function and thus, by inference, variation in the clearance of intraoperative tranexamic acid. This observational hypothesis-generating study in patients undergoing cardiac surgery with cardiopulmonary bypass demonstrated an association between the severity of fibrinolysis resistance, measured on the first post-operative day, and the need for extended postoperative ICU level support. Further examination of the role of persistent fibrinolysis resistance on the clinical outcomes in this patient cohort is warranted through large-scale, well-designed clinical studies.

P904 Appendectomy for refractory ulcerative colitis: results of prospective observational study

Abstract Background Appendectomy is suggested to improve the course of the disease in many patients with refractory ulcerative colitis (UC). The present prospective observational study demonstrates middle-term outcomes after an appendectomy in 26 patients with refractory UC. Methods Between 5/2022 and 2/2023, 26 selected patients underwent appendectomy for refractory UC. Refractory UC was defined as a failure of at least one biologic therapy. Patients with Dysplasia or Cancer were excluded. The appendectomy was performed without the removal of the cecal base. Primary Endpoint of the study was the Mayo clinical score (MCS) at 6 months after the appendectomy. Secondary Endpoint was the “Treatment failure” which was defined as occurrence of one of the following events during the first 6 months after appendectomy: 1) high-dosed steroid treatment, 2) change of biologic treatment, 3) colectomy. Results Mean age was 35 years (18 to 59 years) and there were 11 female patients. 15 had a pancolitis (58%). Twelve were taking steroids (46%). Median number of biologic therapies taken by patients prior to surgery was 3 (range, 1-5). One patient underwent surgery for sever acute UC. The appendix appeared to be inflamed histologically in 16 patients (62%). Hospital stay was median 2 days, there was one wound infection at the port site and one postoperative hematoma. A significant improvement of disease symptoms was reported by 21 patients during the first 4 weeks (81%). At 6 months, MCS improved from mean 6.4 to 4.5 (p=0.057). Therapy failure was observed in 15 patients (58%) – two underwent colectomy, 11 needed at least one high-dose steroid treatment and biologic therapy was changed due to refractory symptoms in 9 patients. Intake of JAK-inhibitors at the time of appendectomy was the only factor to be associated with lower probability of treatment failure (30% vs. 75%, p=0.043). The only patient undergoing appendectomy for severe acute UC was free of symptoms 14 months after surgery. Conclusion The majority of patients with refractory UC demonstrated rapid clinical response to the appendectomy. After 6 months, more than 40% of patients did not experience disease flares necessitating intensification of treatment.

A prospective observational study of real-world treatment and outcome in secondary CNS lymphoma

BackgroundSecondary central nervous system lymphoma (SCNSL) confers a dismal prognosis and treatment advances are constrained by the lack of prospective studies and real-world treatment evidence. MethodsPatients with SCNSL of all entities were included at first diagnosis and patient characteristics, treatment data, and outcomes were prospectively collected in the Secondary CNS Lymphoma Registry (SCNSL-R) (NCT05114330). Findings279 patients from 47 institutions were enrolled from 2011 to 2022 and 243 patients (median age: 66 years; range: 23–86) were available for analysis. Of those, 49 (20 %) patients presented with synchronous (cohort I) and 194 (80 %) with metachronous SCNSL (cohort II). The predominant histology was diffuse large B-cell lymphoma (DLBCL, 68 %). Median overall survival (OS) from diagnosis of CNS involvement was 17·2 months (95 % CI 12–27·5), with longer OS in cohort I (60·6 months, 95 % CI 45·5-not estimable (NE)) than cohort II (11·4 months, 95 % CI 7·8–17·7, log-rank test p < 0.0001). Predominant induction regimens included R-CHOP/high-dose MTX (cohort I) and high-dose MTX/cytarabine (cohort II). Rituximab was used in 166 (68 %) of B-cell lymphoma. Undergoing consolidating high-dose therapy and autologous hematopoietic stem cell transplantation (HDT-ASCT) in partial response (PR) or better was associated with longer OS (HR adjusted 0·47 (95 % CI 0·25–0·89), p = 0·0197). InterpretationThis study is the largest prospective cohort of SCNSL patients providing a comprehensive overview of an international real-world treatment landscape and outcomes. Prognosis was better in patients with SCNSL involvement at initial diagnosis (cohort I) and consolidating HDT-ASCT was associated with favorable outcome in patients with PR or better.

Prospective observational comparative study of outcomes between single-layer versus double-layer gastrointestinal anastomosis

Prospective observational comparative study of outcomes between single-layer versus double-layer gastrointestinal anastomosis

Women achieve equivalent health-related quality of life benefits to men from attending cardiac rehabilitation: a matched case-control study

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): SOLVE-CHD NHMRC Synergy Grant Background/Introduction Coronary heart disease (CHD) is the leading cause of death in women globally; and women have worse health outcomes from CHD than men, including poorer health-related quality of life (HRQL). Comprehensive cardiac rehabilitation (EBCR) has well-established benefit for patients with CHD in improving HRQL. These benefits have rarely been distinguished separately for women despite known differences to men. Purpose The aim of this study was to compare women and men’s HRQL outcomes after accounting for differences in age, partnership status and diagnosis. Methods A secondary analysis of a larger prospective observational study of CR outcomes using a matched case-control study of women and men. The sample included patients enrolled in four CR programs following admission for CHD (myocardial infarction [MI], percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]). Women were matched to men based on age (within 0-2 years), marital status (single, or partnered), and diagnosis (MI, PCI, or CABG). Sociodemographic data were collected from the participants and clinical information (diagnosis, comorbidities) from the medical record. HRQL was measured using the Short Form-12 Health Survey (SF-12). Results Thirty-seven matched women and men were included in this study at baseline, of whom 27 completed the study (72.9%). There were no significance differences in sociodemographic and clinical characteristics between men and women at baseline. Both women and men improved HRQL substantially from pre-post CR, with no significant differences in change scores in any domain between the sexes despite women having worse scores at baseline in Physical Functioning (mean score 41.59 vs 44.15), Bodily Pain (mean score 47.78 vs 48.71) and overall physical summary score (mean score 44.14 vs 45.29). Women had clinically meaningful improvements in Physical Functioning (MD 6.51, 95% CI 2.59-10.44) and Role Physical (MD 6.42, 95% CI 2.81-10.03), Mental Health (MD 4.35, 95% CI 2.05-6.66) and Bodily Pain (MD 4.97, 95% CI 1.36-8.60) and in the overall physical summary score (MD 5.67, 95% CI 1.98-9.38). Men achieved clinically meaningful improvements in the same domains as women plus Vitality (MD 5.11, 95% CI 0.87-9.36) and Social Function (MD 8.54, 95% CI 3.98-13.09). Conclusion(s) When matched to men for age, partnership status, and diagnosis, women achieve clinically meaningful and equivalent HRQL outcomes following CR. Women significantly improved in overall physical and mental health HRQL, as well as in the majority of HRQL domains. These findings could be used to strengthen advocacy in supporting women with CHD to participate and complete CR programs.

A multicenter prospective observational study of lymph node metastasis patterns and short-term outcomes of extended lymphadenectomy in right-sided colon cancer.

The lymph node metastasis rate in right-sided colon cancer is unknown, and the optimal central vascular ligation level remains controversial. We aimed to determine the lymph node metastasis rate and short-term results of radical surgery with extended lymph node dissection in right-sided colon cancer. This prospective multicenter observational study included patients with stage II/III right-sided colon cancer from five cancer hospitals. The metastasis rate of each node station was analyzed according to tumor location and main feeding artery. Between April 2018 and August 2021, 208 patients underwent dissection around the superior mesenteric artery (SMA) and vein (SMV). In transverse colon cancer, 7.5% and 2.5% of metastases occurred around the SMV and SMA at the root of the middle colic artery (MCA), respectively; 6.7% and 6.7% at the root of the right colic artery. In caecal cancer, 1.9% of metastases occurred around the SMV and 1.9% around the SMA. In ascending colon cancer, the rate was 1.1% around the SMV. Of the tumors, 17% fed mainly by the ileocolic artery had node metastases along the middle or right colic artery, as did 66.7% fed mainly by the right colic artery and 41.2% fed by the MCA (p = 0.01). Postoperative complications occurred in 42 patients (20.2%). Routine prophylactic extended lymphadenectomy around the SMA might not be necessary in caecum and ascending colon cancer. Dissection around the SMA may be necessary in cases of transverse colon cancer or when the feeding artery is the MCA.

A Prospective Observational Study of Maternal Perception of Reduced Fetal Movements and Fetal Outcome

Background: Maternal perception of reduced fetal movements (RFM) is associated with increased risk of still birth, preterm labor &amp; fetal growth restriction. RFM is thought to represent fetal compensation to conserve energy due to insufficient oxygen &amp; nutrient transfer resulting from placental insufficiency. Intrauterine fetal death is preceded by RFM for 24 hours in up to 50% cases. In infants who are alive at presentation, RFM is associated with increased incidence of still birth, fetal growth restriction &amp; feto-maternal hemorrhage. However RFM is may also occur in non pathological conditions such as anterior placental site, increased maternal activity &amp; standing position. Inadequate clinician response to complaint of RFM is important contributory factor to still birth. Aims and objectives: To assess association between maternal perceptions of reduced fetal movements and fetal outcome. Methodology: Study was conducted in Department of Obstetrics and Gynecology at Bharati hospital, Pune. It was a prospective observational study of fetal outcomes in mothers perceiving reduced fetal movements. Women after 28 weeks of pregnancy presenting with reduced fetal movements out of that 202 pregnant women were included. Study was conducted from October 2020 to October 2022. Results: Majority of the fetuses were healthy. There was strong association between reduced fetal movements and Oligohydramnios. We found significant association between NICU admission, birth weight, APGAR, and RFM category, while no significant association between RFM category and status at birth and type of delivery. There were 2 IUD’s noted. Conclusion: Fetal movements monitoring is necessary during antenatal period, after 28 weeks of pregnancy, it is a good predictor of fetal outcome, and helps in timely intervention.

Locked intramedullary nailing of open fractures in resource-poor settings: a prospective observational study of challenges and functional outcomes in 101 fractures at Ogbomoso, Nigeria

BackgroundTrauma is now one of the fastest growing epidemics globally but low and middle-income countries (LMICs) are more severely affected in terms of cost, disability and death. The high-energy trauma of road traffic accidents and violence often produces open fractures which can be difficult to manage in resource-poor settings. Adequate stabilization, such as provided by locked nails, has been found to ensure better outcome for open fractures. There is dearth of published studies on the use of locked intramedullary nail in the treatment of open fractures in Nigeria.MethodsThis is a prospective observational study of all the 101 open fractures of the humerus, femur and tibia treated over a period of 92 months with Surgical Implant Generation Network (SIGN) nail. Fracture severity was classified according to the modified Gustilo-Anderson system. The intervals between fracture and antibiotics administration, débridement and definitive fixation, as well as surgery duration and method of fracture reduction were noted. Outcomes measured at follow-up included infection, ongoing radiographic healing, knee flexion/shoulder abduction beyond ninety degrees (KF/SA > 900), full weight bearing (FWB), painless squatting (PS&S)/shoulder abduction-external rotation (SAER).ResultsMost of the patients fall between ages 20 and 49 years; 75.5% of them were males. There were more Gustilo-Anderson type IIIA fractures than other types but nine type IIIB tibia fractures were also nailed. The overall infection rate was 15%, contributed mostly by the type IIIB fractures. By the 12th post-operative week, at least 79% had ongoing radiographic healing and had achieved all of KF/SA > 900, FWB, and PS&S/SAER.ConclusionThe SIGN nail’s solid construct reduces the risk of infection and allows earlier use of the limb, making it particularly suitable in LIMCs where socioeconomic functioning often requires an unhindered use of the limbs.

A Prospective Observational Study of Maternal Outcome in Pregnancy with BMI 25 - 29.9 Kg/M2 (Overweight Pregnant Women) in Tertiary Health Care Center of South Gujarat

A Prospective Observational Study of Maternal Outcome in Pregnancy with BMI 25 - 29.9 Kg/M2 (Overweight Pregnant Women) in Tertiary Health Care Center of South Gujarat

A prospective observational study of functional outcome of fracture distal end of Tibia, treated with minimally invasive plating osteosynthesis (Mippo) technic

Background: Distal tibia fractures including Tibia pilon fractures present a challenge as to their best method of management due to subcutaneous location of larger portion of tibia, paucity of soft tissue coverage and precarious blood supply to the distal leg. The involvement of the ankle joint and the vulnerability of the surrounding soft tissues further complicate these already complex injuries. Numerous classifications have been proposed for these fractures, however AO-OTA alphanumeric classifications the most comprehensive as well as the most commonly quoted classification. The lower end of the tibia including its medial and the lateral malleoli of the fibula form a socket (mortise) into which the body of the talus articulates, and along with capsule and ligament thus form the ankle joint. Any disruption of length, axis or rotation of the fibula or the tibia can result in an incongruent ankle joint. The lateral aspect of the distal tibia forms a triangular notch where the fibula articulates. The interosseous membrane and the anterior and posterior tibiofibular ligaments bind these bones together.Aim: To evaluate the efficiency of internal fixation for the fractures of distal tibia by using minimally invasive plating osteosynthesis [Mippo] technique. To assess the functional outcome of Mippo technique with locking compression plate and dynamic compression plate.Methods: A prospective observational study of patients above the age of 20 years with distal tibia fracture admitted in King George hospital, Visakhapatnam. Study duration 9 months.Results: There were 72 patients in the study including 50 males (69.4%) and 22 females (30.6%) of mean age 46 years. The commonest cause of injury was RTA with High energy trauma with total of 31 patients (43.06%) followed by Low energy RTA with total of 28 patients (38.89%) and the rest 28 of the patients with Low energy fall (18.06%) respectively. All fractures united at an average of 15 weeks (range 12 to 20 weeks). As regards pain, 48 patients (66.66%) were pain-free, 18 patients (25%) had only occasional pain.Conclusion: It is well accepted that the final outcome of distal tibial fractures including pilon fractures with this MIPPO technique, a single stage operative procedure. It is obvious that these are not directly influenced by this technique MIPPO, single-stage operative procedure, contributing to a favorable outcome.

Prospective Observational Study of Pain Severity and Pain Interference Outcomes Following Percutaneous MRI-guided Laser Ablation or Cryoablation for Focal Painful Peripheral, Soft Tissue Vascular Malformations: 12-month Outcomes

Background: Percutaneous image-guided thermal ablation has emerged as a treatment option for vascular malformations (VM). However, prospective data on intermediate to long-term effectiveness with uniform follow-up are lacking. Purpose: To prospectively evaluate the 12-month pain severity and pain interference outcomes following percutaneous MRI-guided laser ablation and cryoablation of focal painful, peripheral soft tissue VM. Materials and Methods: Participants undergoing clinically indicated MRI-guided laser ablation and cryoablation for focal painful (worst pain ≥4 out of 10 on Visual Analog Scale), peripheral soft tissue vascular malformations (VM) were enrolled in an IRB-approved prospective, observational study after giving informed consent. Participants completed the Brief Pain Inventory questionnaire prior to ablation and 1, 3, 6, and 12-month postablation. Differences in pain severity and interference outcomes from baseline on a 0 to 10 scale were compared using a paired t-test. Results: Seventeen participants (15 female; mean age 28.3 ± 9.3 years) underwent 24 MRI-guided and monitored ablation sessions including laser (n = 21), cryoablation (n = 2), or both (n = 1) for treatment of painful slow-flow (n = 16) or high-flow (n = 1) VM. Median maximal VM diameter was 5.7 cm (range 1.1 to 31.0 cm). Mean (±SD) preablation worst pain score was 7.9 ± 1.4. There was a significant decrease in worst pain at 1-month postablation (–3.5 ± 2.9; P = .0007) that was sustained at 3 (–3.4 ± 3.2; P = .0007), 6 (–4.2 ± 3.6; P = .0003), and 12 months (–3.6 ± 3.9; P = .002), with similar results for average, current, and least pain scores. There was a significant improvement in pain interference outcomes at 12-month postablation: general activity (P = .018), walking ability (P = .008), work (P = .003), sleep (P = .007), and enjoyment of life (P = .033). Conclusions: These data suggest that MRI-guided and monitored thermal ablation is safe and provides early and sustained significant improvements in pain severity and pain interference outcomes during the first year of follow-up in participants with focal painful peripheral soft tissue VM.

Prognostic Value of Histological and Immunohistochemical Data in Diabetic Foot Ulcers

A clinical prospective observational study of the treatment outcomes of fifty-three patients with diabetic foot ulcers hospitalized twice in one specialized centre over the course of the year was conducted. The analysis of histological and immunohistochemical data of the tissues of the edges and the centre of the ulcer taken during the primary surgical treatment was performed. While performing histological analyses of wound tissues, special attention was given to the determination of cellular characteristics of leukocyte-necrotic masses, granulation tissue, and loose and dense connective tissue. Immunohistochemistry was performed using a set of monoclonal antibodies, allowing verification of neutrophilic leukocytes, fibroblasts, and endothelial cells. Unfavourable outcomes (amputation, reamputation, death from cardiovascular diseases, nonhealing ulcer within a year) were registered in 52.8% of cases. Uniform distribution of neutrophils and endothelial cell fibroblasts in all parts of the wound was recorded in patients with a favourable outcome. An unfavourable outcome was predetermined by the uneven content of these cells with a significant increase in neutrophilic leukocytosis in the bottom of the wounds, as well as a significant decrease in the number of fibroblasts and endotheliocytes in the centre of the wounds. The datasets obtained during primary surgical treatment are extremely informative to predict the outcome of the treatment of diabetic foot ulcers and indicate more active surgical strategies with the potential to reduce the treatment time, increase its effectiveness, and eventually make the treatment cost-effective.

Open preperitoneal ventral hernia repair: Prospective observational study of quality improvement outcomes over 18 years and 1,842 patients

BackgroundThis study aimed to describe progressive evidence-based changes in perioperative management of open preperitoneal ventral hernia repair and subsequent surgical outcomes and to analyze factors that affect recurrence and wound complications. MethodsProspective, tertiary hernia center data (2004–2021) were examined for patients undergoing midline open preperitoneal ventral hernia repair with mesh. “Early” (2004–2012) and “Recent” (2013–2021) groups were based on surgery date. ResultsComparison of Early (n = 675) versus Recent (n = 1,167) groups showed that Recent patients were, on average, older (56.9 ± 12.6 vs 58.7 ± 12.1 years; P < .001) with a lower body mass index (33.5 ± 8.3 vs 32.0 ± 6.8 kg/m2; P = .003) and a higher number of comorbidities (3.6 ± 2.2 vs 5.2 ± 2.6; P < .001). Recent patients had higher proportions of prior failed ventral hernia repair (46.5% vs 60.8%; P < .001), larger hernia defects (199.7 ± 232.8 vs 214.4 ± 170.5 cm2; P < .001), more Center for Disease Control class 3 or 4 wounds (11.3% vs 18.6%; P < .001), and more component separations (22.5% vs 45.7%; P < .001). Hernia recurrence decreased over time (7.1% vs 2.4%; P < .001), as did wound complication rates (26.7% vs 13.2%; P < .001). Comparing respective multivariable analyses (Early versus Recent), wound complications were associated with panniculectomy (odds ratio [95% confidence interval]: 2.9 [1.9–4.5], P < .001 vs 2.1 [1.4-3.3], P < .01), contaminated wounds (2.1 [1.1–3.7], P = .02 vs 1.8 [1.1–3.1], P = .02), anterior component separation technique (1.8 [1.1–2.9], P = .02 vs 3.2[1.9–5.3], P < .01), and operative time (per minute: 1.01 [1.008–1.015], P < .01 vs 1.004 [1.001–1.007], P < .01). Diabetes (2.6 [1.7–4.0], P < .01) and tobacco (1.8 [1.1–2.9], P = .02) were only significant in the early group. In both groups, recurrence was associated with wound complication (8.9 [4.1–20.1], P < .01 vs 3.4 [1.3–8.2]. P < .01) and recurrent hernias (4.9 [2.3–11.5], P < .01 vs 2.1 [1.1–4.2], P = .036). ConclusionDespite significant increased patient complexity over time, detecting and implementing best practices as determined by recurring data analysis of a center’s outcomes has significantly improved patient care results.

Tracheostomy in critically ill patients with SARS 2 COVID-19 infection: a prospective observational multi-center study of short- and long-term outcomes.

BackgroundWe report the characteristics, timing, and factors related to the decision to perform a tracheostomy in patients with confirmed COVID-19 infection admitted to eight Italian intensive care units (ICUs).Materials and methodsProspective observational cohort study of patients with COVID-19 disease on mechanical ventilation. Long-term functional impairment (up to 180 days’ post-hospital discharge) was assessed using the Karnofsky scale. Kaplan–Meier analysis assessed differences in survival and freedom from tracheostomy in relation to ICU stay. Cox regression model was used to assess which variables impacted on tracheostomy as a categorical outcome.ResultsA total of 248 patients were recruited in the eight participating ICUs. Patients undergoing tracheostomy (n = 128) had longer ICU (25 (18–36) vs. 10 (7–16), P = 0.001) and hospital (37 (26.5–50) vs. 19 (8.5–34.5) P = 0.02) stays. ICU and hospital mortality of patients tracheostomized was 34% and 37%, respectively. Cumulative survival Kaplan–Meier analysis documented improved survival rates in patients undergoing tracheostomy (Log-Rank, Mantel–Cox = 4.8, P = 0.028). Median Karnofsky scale values improved over time but were similar between survivors receiving or not receiving tracheostomy. No healthcare worker involved in the tracheostomy procedure developed COVID-19 infection during the study period.ConclusionsPatients with COVID-19 infection who underwent tracheostomy had a better cumulative survival but similar long-term functional outcomes at 30, 60, and 180 days after hospital discharge.

Outcomes and Predictors of Outcome with Cisternostomy in the Management of Traumatic Brain Injury—A Prospective Observational Study at a Tertiary Centre

Abstract Background Traumatic brain injury (TBI) is a major cause of morbidity and mortality in young individuals. Goal of management in TBI patients is mainly focused on the secondary injury. Since the cisterns and the brain communicate, it would be possible to decrease the pressure in both these compartments by opening the cisterns to the atmospheric pressure. Objective To study the outcomes and predictors of outcome with cisternostomy in the management of TBI. Methods A single tertiary care center's prospective observational study of outcomes with cisternostomy with intraoperative intracranial pressure (ICP) monitoring. Patients were evaluated clinically and radiologically with Marshall CT score. They were categorized into mild, moderate, and severe head injury groups based on Glasgow coma scale (GCS) score. Outcomes were evaluated with Glasgow outcome scale (GOS) score. Results A total of 25 patients with TBI were enrolled in this study. They underwent cisternostomy with intraoperative ICP monitoring. They were categorized into 4 groups based on the age. In our study, mortality rate was 32%. As much as 48% had good recovery at 3 months follow-up with GOS 4 and 5. Mean ICP after cisternostomy was 6.36 ± 1.91 mm Hg. In our study, there was decrease in ICP after cisternostomy. Conclusion Age, time interval from trauma to surgery, and ICP showed prognostic importance on outcomes. Cisternostomy can efficiently decrease the ICP in the TBI patients and reduce postoperative complications.

Functional limitations 12 months after SARS-CoV-2 infection correlate with initial disease severity: An observational study of cardiopulmonary exercise capacity testing in COVID-19 convalescents

BackgroundCardiopulmonary Exercise Testing (CPET) provides a comprehensive assessment of pulmonary, cardiovascular and musculosceletal function. Reduced CPET performance could be an indicator for chronic morbidity after COVID-19. MethodsPatients ≥18 years with confirmed PCR positive SARS-CoV-2 infection were offered to participate in a prospective observational study of clinical course and outcomes of COVID-19. 54 patients completed CPET, questionnaires on respiratory quality of life and performed pulmonary function tests 12 months after SARS-CoV-2 infection. ResultsAt 12 months after SARS-CoV-2 infection, 46.3% of participants had a peak performance and 33.3% a peak oxygen uptake of <80% of the predicted values, respectively. Further impairments were observed in diffusion capacity and ventilatory efficiency. Functional limitations were particularly pronounced in patients after invasive mechanical ventilation and extracorporeal membrane oxygenation treatment. Ventilatory capacity was reduced <80% of predicted values in 55.6% of participants, independent from initial clinical severity. Patient reported dyspnea and respiratory quality of life after COVID-19 correlated with CPET performance and parameters of gas exchange. Risk factors for reduced CPET performance 12 months after COVID-19 were prior intensive care treatment (OR 5.58, p = 0.004), SGRQ outcome >25 points (OR 3.48, p = 0.03) and reduced DLCO (OR 3.01, p = 0.054). ConclusionsFunctional limitations causing chronic morbidity in COVID-19 survivors persist over 12 months after SARS-CoV-2 infection. These limitations were particularly seen in parameters of overall performance and gas exchange resulting from muscular deconditioning and lung parenchymal changes. Patient reported reduced respiratory quality of life was a risk factor for adverse CPET performance.