Prospective Observational Trial Research Articles

Haemolysis and acute tubular injury after pulsed field ablation compared to radiofrequency: An observational study

Abstract Background Pulsed field ablation (PFA) represents a novel promising non-thermal alternative in non-pharmacological treatment of atrial fibrillation (AF). However, infrequent cases of acute renal failure secondary to intravascular haemolysis after a PFA procedure have been described. Objective To investigate the impact of ablation technology (PFA vs. radiofrequency ablation (RFA)) on the level of plasma cell-free haemoglobin (CFH) and the concentration of serum neutrophil gelatinase-associated lipocalin (NGAL) as a marker of tubular injury. Methods This was a prospective observational trial. In a consecutive cohort of patients who underwent AF ablation (PFA of RFA), blood samples were drawn just before the procedure (Sample 1: CFH and NGAL), immediately after the procedure (Sample 2: CFH) and one day after the procedure (Sample 3: CFH and NGAL). Plasma CHF level and serum NGAL concentration were analysed using the ELISA technique. Results Among 70 patients enrolled (mean age 64.3 ± 10.3 years, 61 % male), 23 underwent RFA and 47 PFA (22 pulmonary vein isolation (PVI) only and 25 PVI with other additive lesions). Baseline serum creatinine levels of both groups were comparable (91.7 ± 22.1 µmol/L vs. 88.8 ± 22.1 µmol/L P = 0.44). In the PFA cohort, a significant peak of CFH concentration was observed just after the procedure with a subsequent decrease within 12 hours (Sample 1 vs. Sample 2: 93.4 ± 65.1 µg/mL vs. 2394.9 ± 1966.1 µg/mL P < 0.001, Sample 1 vs. Sample 3: 93.4 ± 65.1 µg/mL vs. 97.2 ± 68.5 µg/mL P = 0.75). No significant differences were observed in the RFA cohort. Compared to baseline, neither the PFA nor the RFA group showed a significant difference in NGAL levels (PFA 98.6 ± 31.7 ng/mL vs. 98.5 ± 38.1 ng/mL P = 0.78, RFA 108.3 ± 33.8 ng/mL vs. 116.3 ± 32.2 ng/mL P = 0.49). Conclusions Compared to RFA, PFA leads to significant peri-procedural haemolysis. However, no differences in the concentration of the tubular injury marker NGAL were observed on the first day after the procedure.

Head-to-head comparison of 68Ga-FAPI-46 PET/CT, 18F-FDG PET/CT, and contrast-enhanced CT for the detection of various tumors.

FAPI-PET/CT exhibits high tumor uptake and low background accumulation, enabling high-sensitivity tumor detection. We compared the diagnostic performance of 68Ga-FAPI-46 PET/CT plus contrast-enhanced CT (CE-CT), 18F-FDG PET/CT plus CE-CT, and standalone CE-CT in patients with various malignancies. 232 patients underwent 68Ga-FAPI-46 PET/CT,18F-FDG PET/CT, and CE-CT each within 4weeks. Detection rates were assessed by a blinded reader, with ≥ 2weeks between scans of the same patient to avoid recall bias. A sub-analysis of diagnostic performance was performed for 490 histopathologically validated lesions. Detection rates were compared using McNemar's test. Lesion-based detection rates in 68Ga-FAPI-46 PET/CT plus CE-CT, 18F-FDG PET/CT plus CE-CT, and CE-CT alone were 91.2% (1540/1688), 82.5% (1393/1688) and 60.2% (1016/1688). The detection rates were significantly higher for 68Ga-FAPI-46 PET/CT plus CE-CT than for 18F-FDG PET/CT plus CE-CT (p < 0.02 for primary lesions and p < 0.001 for total, abdominopelvic nodal, liver and other visceral lesions) and CE-CT (p < 0.0001 for total, primary, cervicothoracic nodal, abdominopelvic nodal, liver, other visceral, and bone lesions). In the sub-analysis, sensitivity, specificity, positive and negative predictive value, and accuracy were 61.3%, 96.7%, 81.4%, 91.4% and 90.0% for 68Ga-FAPI-46 PET/CT plus CE-CT, 57.0%, 95.7%, 75.7%, 90.5% and 88.4% for 18F-FDG PET/CT plus CE-CT, and 51.6%, 97.2%, 81.4%, 89.6% and 88.6% for CECT, respectively. 68Ga-FAPI-46 PET/CT plus CE-CT demonstrates a higher tumor detection rate than 18F-FDG PET/CT plus CE-CT and CE-CT in a diverse spectrum of malignancies, especially for primary, abdominopelvic nodal, liver, and other visceral lesions. Further studies on which entities draw particular benefit from 68Ga-FAPI-46 PET/CT are warranted to aid appropriate diagnostic workup. A total of N = 232 patients were analyzed. Of these, N = 50 patients were included in a prospective interventional trial (NCT05160051), and N = 175 in a prospective observational trial (NCT04571086) for correlation and clinical follow-up of PET findings; N = 7 patients were analyzed retrospectively.

Prospective observational non-randomized trial protocol for surgical planner 3D image processing & reconstruction for locally advanced colon cancer

IntroductionColon cancer presents significant surgical challenges that necessitate the development of precise strategies. Standardization with complete mesocolic excision (CME) is common, but some cases require extended resections. This study investigates the use of 3D Image Processing and Reconstruction (3D-IPR) to improve diagnostic accuracy in locally advanced colon cancer (LACC) with suspected infiltration and achieve R0 surgery.MethodsSingle-center, prospective, observational, comparative, non-randomized study.•Participants: Patients aged > 18 years undergoing LACC surgery, as indicated by CT scans, confirmed via colonoscopy. Exclusion criteria include neoadjuvant therapy, suspected carcinomatosis on CT, and unresectable tumors.•Interventions: 3D-IPR models are used for surgical planning, providing detailed tumor and surrounding structure metrics. Surgical procedures are guided by CT scans and intraoperative findings, categorized by surgical margins as R0, R1, or R2.•Objective: The primary goal is to evaluate 3D-IPR’s utility in achieving R0 resection in LACC with suspected infiltration. Secondary objectives include assessing preoperative surgical strategy, comparing CT reports, detecting adenopathy, and identifying vascularization and anatomical variants.• Outcome: The main outcome is the diagnostic accuracy of 3D-IPR in determining tumor infiltration of neighboring structures compared to conventional CT scans, using definitive pathological reports as the gold standard.Results•Recruitment and Number Analyzed: The study aims to recruit about 20 patients annually over two years, focusing on preoperative 3D-IPR analysis and subsequent surgical procedures.•Outcome Parameters: These include loco-regional and distant recurrence rates, peritoneal carcinomatosis, disease-free and overall survival, and mortality due to oncologic progression.•Harms: No additional risks from CT scans, as they are mandatory for staging colon tumors. 3D-IPR is derived from these CT scans.DiscussionIf successful, this study could provide an objective tool for precise tumor extension delimitation, aiding decision-making for radiologists, surgeons, and multidisciplinary teams. Enhanced staging through 3D-IPR may influence therapeutic strategies, reduce postsurgical complications, and improve the quality of life of patients with LACC.Trial registrationTrial is registered at ISRCTN registry as ISRCTN81005215. Protocol version I (Date 29/06/2023).

Assessment of superior vena cava diameter and collapsibility index in liver transplantation: a prospective observational study

BackgroundSuperior Vena Cava (SVC) diameter and collapsibility index, dynamic measures of fluid responsiveness, have been successfully utilized as echocardiographic indices for fluid responsiveness in ventilated septic patients. Whether these measurements are correlated with Central Venous Pressure (CVP) measurements in liver transplant patients is unknown. We sought to assess the correlation of maximum and minimum SVC diameter and SVC collapsibility index measurements obtained intraoperatively by Transesophageal Echocardiography (TEE) with those of simultaneously recorded CVP measurements obtained through a right atrial port of a pulmonary artery catheter. The secondary aim of the study was to assess the correlation between SVC measurements and simultaneously obtained thermodilution cardiac index measurements. MethodsSingle center prospective observational trial of patients with end stage liver disease undergoing liver transplantation in an academic tertiary care center. ResultsThe minimum SVC exhibited a mild significant correlation with CVP as did the maximum SVC. The correlation between the SVC collapsibility index and CVP was not significantly different from zero. In our secondary analysis, the correlation between minimum SVC diameter and cardiac index was determined to be weak but non-zero as was the correlation between the maximum SVC diameter and cardiac index. The correlation between SVC collapsibility index and cardiac index was not different from zero. ConclusionWhile statistically significant, the weak clinical correlation of intraoperative SVC measurements obtained by TEE make them unsuitable as a replacement for central venous pressure or thermodilution cardiac index measurements in liver transplant recipients.

Study design and procedures in the incontinence post robot-assisted radical prostatectomy: anatomical and functional causes (IPA) - a prospective observational clinical trial.

To describe the study design and procedures of the incontinence post robot- assisted radical prostatectomy, anatomical and functional causes (IPA) trial. This trial aims to identify and study patient and procedure specific factors leading to urinary incontinence post robot-assisted laparoscopic radical prostatectomy (RALP). The IPA study is a prospective, multicentre, open non-randomised surgical trial, including patients prior to RALP and registered on-line (ISRCTN67297115). IPA is administered from the Department of Urology at Sahlgrenska University Hospital, Gothenburg, Sweden. Patients undergo an anatomical and functional evaluation using magnetic resonance imaging (MRI), urodynamics including cystometry, pressure-flow and urethral pressure profile, and dynamic transrectal ultrasound prior to and 3 months after RALP. The incontinence data are gathered using patient reported outcome measure questionnaires. The primary endpoint is incontinence at 3 months after RALP, defined as need of any pad. The secondary endpoints are incontinence 12 months post RALP defined as need of any pad, and 3- and 12-months post RALP, defined as use of more than a safety pad. Until October 2023, 207 patients have been included of the stipulated 1,000, with an increasing rate of accrual. Out of these patients,187 have had a pre- and post-operative MRI and 177 have undergone pre- and post-operative urodynamics. The design of the IPA study, together with promising accrual and coming multicentre inclusion, will hopefully result in the identification, and deeper understanding, of the various risk-factors for post-RALP incontinence. This could improve information and decision making regarding adequate treatment for patients with prostate cancer.

Group dynamics and therapy outcome of multimodal pain therapies: A prospective observational trial

AbstractBackgroundFor the treatment of chronic pain, interdisciplinary treatment programs are recommended. Despite continuous adaptation and optimization of this cost‐ and time‐intensive and comprehensive form of therapy, it is not successful in some patients. As personality disorders have an important influence on social interaction and behaviour, the aim of our study was to identify the possible impact of patients with personality disorders on group dynamics and to analyse the influence of group dynamics on individual therapy outcomes.MethodsWe conducted a prospective observational study in patients with chronic pain (N = 104) who participated in a 5‐week interdisciplinary treatment program. The main outcome parameters were psychological state and pain intensity before and after the program.ResultsIn contrast to our clinical assumption, we found that neither the type nor the number of patients with personality accentuation or personality disorders had a clinically relevant influence on group dynamics and that even a negative group dynamic did not negatively influence the individual therapy outcome.DiscussionThis trial analysed the connection between group dynamics and therapy outcome of multimodal pain therapies in chronic pain patients considering the factor of personality disorders. Our data demonstrated that neither the type nor the number of patients with personality disorders had a clinically relevant influence on group dynamics and that even a negative group dynamic did not negatively influence the individual therapy outcome. Hence, clinicians should not be afraid to include patients with personality disorders in their treatment programs.Significance StatementThe study emphasizes that clinicians may include patients with personality disorders in multimodal pain treatment programs and groups, provided that the maintenance of a close therapeutic bond with the patient and within the interdisciplinary team is given.

Wound infection rate after skin closure of damage control laparotomy with wicks or incisional negative wound therapy: An EAST multi-center trial.

Damage control laparotomy (DCL) has a high risk of SSI and as an attempt to mitigate this, surgeons often leave the skin open to heal by secondary intention. A recent retrospective study showed that DCL wounds could be closed with the addition of wicks or incisional wound vacs with acceptable rates of wound infection. The aim of this prospective trial was to corroborate these results.This is a prospective multicenter observational trial performed by 7 institutions from July 2020 to April 2022. Adult patients who underwent DCL and fascia/skin closure with the addition of wicks or an incisional wound vac were included. Patients who died within seven days of DCL were excluded. Demographics, mechanism of initial presentation, wound classification, antibiotics given, surgical site infections, procedures performed, and mortality data was collected. Fisher's Exact test was used for categorical data and Wilcoxon Rank Sum test for continuous data. Mean days to closure was assessed using Student's t-test for independent groups. P-values <0.05 were considered indicative of statistical significance.Over the 21-month period, a total of 119 patients analyzed. Most patients were male (n = 66, 63 %), and the average age was 51 years. The average number of days the abdomen was kept open was 2.6. A majority of the DCLs were performed on acute care patients (n = 76, 63.8 %) and 92 patients (77.3 %) had a wound classification of contaminated or dirty. Most of the patients’ skin was closed with wicks in place (68.9 %). There was a 9.8 % infection rate in patient's skin closed with wicks versus 16.2 % closed with an incisional wound vac (p = 0.361).Although the wick group had a higher proportion of class III and IV wound types, patients primarily treated with wicks had a lower risk of wound infection compared to those treated with incisional wound VACs; however, this difference was not statistically significant.

Extravascular lung water assessment by lung ultrasound in infants following pediatric cardiac surgery.

Lung edema is a significant factor in prolonged mechanical ventilation and extubation failure after cardiac surgery. This study assessed the predictive capability of point-of-care Lung Ultrasound (LUS) for the duration of mechanical ventilation and extubation failure in infants following cardiac procedures. We conducted a prospective observational trial on infants under 1 year, excluding those with pre-existing conditions or requiring extracorporeal membrane oxygenation. LUS was performed upon intensive care unit (ICU) admission and prior to extubation attempts. B-line density was scored by two independent observers. The primary outcomes included the duration of mechanical ventilation and extubation failure, the latter defined as the need for reintubation or non-invasive ventilation within 48 h post-extubation. The study included 42 infants, with findings indicating no correlation between initial LUS scores and extubation timing. Extubation failure occurred in 21% of the patients, with higher LUS scores observed in these cases (p = 0.046). However, interobserver variability was high, impacting the reliability of LUS scores to predict extubation readiness. LUS was ineffective in determining the length of postoperative ventilation and extubation readiness, highlighting the need for further research and enhanced training in LUS interpretation.

Urinary chloride excretion in critical illness and acute kidney injury: a paediatric hypothesis-generating cohort study post cardiopulmonary bypass surgery.

Renal chloride metabolism is currently poorly understood but may serve as both a diagnostic and a treatment approach for acute kidney injury. We investigated whether plasma chloride, ammonia and glutamine as well as urinary chloride, ammonium and glutamine concentrations may serve as markers for acute kidney injury in paediatric patients. We conducted a prospective observational trial in a tertiary care paediatric intensive care unit. Ninety-one patients after cardiopulmonary bypass surgery were enrolled. Plasma glutamine, creatinine, (serum) albumin, urinary electrolytes and glutamine were collected pre-cardiopulmonary bypass surgery, at paediatric intensive care unit admission, and at 6, 12, 24, 48 and 72 h after paediatric intensive care unit admission. The urinary strong ion difference was calculated. The median urinary chloride excretion decreased from 51 mmol/L pre-cardiopulmonary bypass to 25 mmol/L at paediatric intensive care unit admission, and increased from 24 h onwards. Patients with acute kidney injury had lower urinary chloride excretion than those without. The median urinary strong ion difference was 59 mmol/L pre-cardiopulmonary bypass, rose to 131 mmol/L at 24 h and fell to 20 mmol/L at 72 h. The plasma chloride rose from 105 mmol/L pre-cardiopulmonary bypass to a maximum of 109 mmol/L at 24 h. At 24 h the plasma chloride concentration was associated with the presence of acute kidney injury. There was no association between plasma or urinary amino acids and chloride excretion or kidney injury. In conclusion, renal chloride excretion decreased in all patients, although this decrease was more pronounced in patients with acute kidney injury. Our findings may reflect a response of the kidneys to critical illness, and acute kidney injury may make these changes more pronounced. Targeting chloride metabolism may offer treatment approaches to acute kidney injury.

The Effect of Anesthesia Type on the Stability of the Surgical View on the Monitor in Retrograde Intrarenal Surgery for Renal Stone: A Prospective Observational Trial.

Background and Objectives: Retrograde intrarenal surgery (RIRS) is a minimally invasive technique for nephrolithiasis. RIRS is performed via a monitor screen displaying a magnified surgical site. Respiration can affect the stability of the surgical view during RIRS because the kidneys are close to the diaphragm. The purpose of this trial is to compare the effect of anesthesia type on the stability of the surgical view during RIRS between spinal anesthesia and general anesthesia. Materials and Methods: Patients were allocated to the general anesthesia group or spinal anesthesia group. During surgery, movement of the surgical field displayed on the monitor screen was graded by the first assistant on a 10-grade numeric rating scale (0-10). Next, it was also graded by the main surgeon. After surgery, we evaluated the discomfort with the anesthesia method for all patients. Results: Thirty-four patients were allocated to the general anesthesia group and 32 patients to the spinal anesthesia group. The average values of the two surgeons for surgical field oscillation grade showed vision on the monitor screen was more stable in the general anesthesia group than the spinal anesthesia group (3.3 ± 1.6 vs. 5.0 ± 1.6, p < 0.001). The degrees of the inconvenience of the surgery did not differ between the groups (0.7 ± 1.8 vs. 1.6 ± 2.6, p = 0.114), even though more patients reported inconvenience with a grade of 3 or more in the spinal anesthesia group (8.8% vs. 28.1%, p = 0.042). Conclusions: In terms of the visualization of the surgical site, general anesthesia might provide a more stable surgical view during RIRS compared to spinal anesthesia without increasing inconvenience induced by the type of anesthesia.

Estimation of the difference between peritoneal microenvironment and core body temperature during laparoscopic surgery – a prospective observational study

Maintaining patients’ temperature during surgery is beneficial since hypothermia has been linked with perioperative complications. Laparoscopic surgery involves the insufflation of carbon dioxide (CO2) into the peritoneal cavity and has become the standard in many surgical indications since it is associated with better and faster recovery. However, the use of cold and dry CO2 insufflation can lead to perioperative hypothermia. We aimed to assess the difference between intraperitoneal and core temperatures during laparoscopic surgery and evaluate the influence of duration and CO2 insufflation volume by fitting a mixed generalized additive model. In this prospective observational single-center cohort trial, we included patients aged over 17 with American Society of Anesthesiology risk scores I to III undergoing laparoscopic surgery. Anesthesia, ventilation, and analgesia followed standard protocols, while patients received active warming using blankets and warmed fluids. Temperature data, CO2 ventilation parameters, and intraabdominal pressure were collected. We recruited 51 patients. The core temperature was maintained above 36 °C and progressively raised toward 37 °C as pneumoperitoneum time passed. In contrast, the intraperitoneal temperature decreased, thus creating a widening difference from 0.4 [25th–75th percentile: 0.2–0.8] °C at the beginning to 2.3 [2.1–2.3] °C after 240 min. Pneumoperitoneum duration and CO2 insufflation volume significantly increased this temperature difference (P < 0.001 for both parameters). Core vs. intraperitoneal temperature difference increased linearly by 0.01 T °C per minute of pneumoperitoneum time up to 120 min and then 0.05 T °C per minute. Each insufflated liter per unit of time, i.e. every 10 min, increased the temperature difference by approximately 0.009 T °C. Our findings highlight the impact of pneumoperitoneum duration and CO2 insufflation volume on the difference between core and intraperitoneal temperatures. Implementing adequate external warming during laparoscopic surgery effectively maintains core temperature despite the use of dry and unwarmed CO2 gases, but peritoneal hypothermia remains a concern, suggesting the importance of further research into regional effects.Trial registration: Clinicaltrials.gov: NCT04294758.

Assessing the potential of artificial intelligence to enhance colonoscopy adenoma detection in clinical practice: a prospective observational trial.

This study aimed to evaluate the effectiveness of the GI Genius (Medtronic) module in clinical practice, focusing on the adenoma detection rate (ADR) during colonoscopy. Computer-aided polyp detection (CADe) systems using artificial intelligence have been shown to improve adenoma detection in controlled trials. However, the effectiveness of these systems in clinical practice has recently been questioned. This single-center prospective observational study was conducted at the University Hospital of Southern Denmark and included all individuals referred for colonoscopy between November 2020 and January 2021. The primary outcome was ADR, comparing patients examined with CADe to those examined without it. The selection of patients to be examined with the CADe module was completely random. A total of 502 patients were analyzed (318 in the control group and 184 in the CADe group). The overall ADR was 32.1% with a slight increase in the CADe group (34.7% vs. 30.5%). Multivariable analysis showed a very modest and statistically insignificant increase in ADR (risk ratio, 1.12; 95% confidence interval, 0.88-1.43). The use of CADe in clinical practice did not increase ADR with statistical significance when compared to colonoscopy without CADe. These findings suggest that the impact of CADe systems in everyday clinical practice are modest.

The impact of breastfeeding on the preterm infant's microbiome and metabolome: a pilot study.

Human milk is unquestionably beneficial for preterm infants. We investigated how the transition from tube to oral/breastfeeding impacts the preterm infants' oral and gut microbiome and metabolome. We analyzed stool, saliva, and milk samples collected from a cohort of preterm infants enrolled in the MAP Study, a prospective observational trial. The microbiome and metabolome of the samples were analyzed from 4 longitudinal sample time points, 2 during tube feeds only and 2 after the initiation of oral/breastfeeding. We enrolled 11 mother-infant dyads (gestational age = 27.9 (23.4-32.2)) and analyzed a total of 39 stool, 44 saliva, and 43 milk samples over 4 timepoints. In saliva samples, there was a shift towards increased Streptococcus and decreased Staphylococcus after oral feeding/breastfeeding initiation (p < 0.05). Milk sample metabolites were strongly influenced by the route of feeding and milk type (p < 0.05) and represented the pathways of Vitamin E metabolism, Vitamin B12 metabolism, and Tryptophan metabolism. Our analysis demonstrated that the milk and preterm infant's saliva microbiome and metabolome changed over the course of the first four to 5 months of life, coinciding with the initiation of oral/breastfeeds. The microbiome and metabolome is altered in the infant's saliva but not their stool, and in mother's milk when feeds are transitioned from tube to oral/breastfeeding. We assessed the relationship between the gut and oral microbiome/metabolome with the milk microbiome/metabolome over a longitudinal period of time in preterm babies. Metabolites that changed in the infants saliva after the initiation of oral feeds have the potential to be used as biomarkers for disease risk.

Understanding how traumatic brain injury-related changes in fluid biomarkers affect quality of life outcomes in veterans: a prospective observational trial protocol (UNTANGLE)

IntroductionTraumatic brain injury (TBI) is a major cause of disability, with annual global incidence estimated as 69 million people. Survivors can experience long-term visual changes, altered mental state, neurological deficits...

Safety and Efficacy of Lecoxen Cream on the Wound Healing and Scar of Cesarean Section: A Prospective Observational Clinical Trial

Safety and Efficacy of Lecoxen Cream on the Wound Healing and Scar of Cesarean Section: A Prospective Observational Clinical Trial

P-761 Four-dimensional ultrasound using an electronic probe to guide embryo transfer: a feasibility study

Abstract Study question Is four-dimensional ultrasound (4D-US) guided embryo transfer feasible and safe? Summary answer 4D trans-abdominal US with electronic probe is feasible and safe and justifies a formal study for non-inferiority to two-dimensional ultrasound (2D-US) for embryo transfer guidance. What is known already The use of 2D-US to guide embryo transfer is the usual procedure (Eshre/ASRM guidelines, evidence A), and investigations of the benefits of 3D and 4D-US have been inconclusive. 3D-US can locate the embryo flash in the coronal plane immediately after performing embryo transfer but furnishes only retrospective information. 4D-US requires two operators at transfer, and there has been slow image acquisition and poor image quality, not allowing satisfactory comparison of accuracy and precision with other methods. Study design, size, duration Using a high-end ultrasound device (Voluson E10, GE Healthcare, Zipf, Austria) with an electronic 3D-4D probe (eM6C G2), a prospective observational trial with 29 women undergoing mock embryo transfer in a private infertility clinic was performed between October 2023 and January 2024. Exclusion of subjects included BMI greater than 35 (3 cases) and an intramural myoma that impeded 4D-US visualization (3 cases). Participants/materials, setting, methods Two operators expert in U/S performed each procedure. Electronic probe settings were adapted for each subject. To simulate the embryo transfer, a Wallace catheter containing air and fluid was inserted and monitored transabdominally by 4D-US using the electronic probe. The catheter was observed until it reached 1 cm from the fundus and the embryo flash (bubble) identified. Entrance through the cervix was controlled by 2D and 4D. Main results and the role of chance The following variables were recorded: age, BMI, cycle day, use of hormones, endometrial thickness, position of the uterus, presence of fibroids, image quality, difficulty of entrance, visualization of the cervix. The 23 subjects had the following characteristics: mean age 39±6.4, BMI 24.14±4.4. Image quality was optimal in 18 patients and due to a retroverted uterus was suboptimal in 5 subjects. Cannulation of the cervix was difficult in 1. Eight patients were on birth control pills and 15 were on day 6-10 of spontaneous cycles. The mean endometrial thickness was 7.13±3mm. Mean hysterometry was 7.10±0.9mm. Visualization of the cervix with 4D-US was good in 12 subjects, fair in 7 and poor in 4. Visualization of the catheter in the cavity with 4D-US was good in 16 subjects, fair in 2 and poor in 5. The embryo flash was adequately visualized by 4D-US in 18 subjects and less well in 5. Catheter position was correctly identified by comparison 3D-US in 20/23 subjects. There were no adverse effects during or following the procedure. Limitations, reasons for caution Patients with poor image quality, due to obesity, retroverted uterus or fibroids, are not candidates for this technique. The need for two operators limits the practicability of the procedure, increasing the need to show its superiority over the usual practice before it could be adopted clinically. Wider implications of the findings 4D-US for embryo placement is feasible and safe. Studies that compare the accuracy and precision of 4D-US vs 2D-US to guide embryo transfer and the cost/benefit ratio of 4D ultrasound guided embryo transfer are in order.. Trial registration number not applicable for non-clinical trials

O-088 Effect of low, medium and high risk chemotherapy on the ovarian reserve in children: results of the interim analysis of a prospective multicentric trial (CHANCE)

Abstract Study question How does the ovarian reserve of children diagnosed with cancer recover after chemotherapy that is considered as low or medium risk of future infertility? Summary answer The study showed no evidence that low and medium risk treatments impact the future ovarian function in children. What is known already Acute premature ovarian insufficiency (POI) post childhood cancer treatment is estimated around 6%, varying with treatment type and age at diagnosis. Long-term risk of treatment-related infertility is challenging to assess in this population as most of the data comes from retrospective trials involving adult cohorts of childhood cancer survivors. Benefit of fertility preservation at diagnosis is evident for high risk patients. However, for low or medium risk patients, the lack of knowledge on treatment effect on the ovarian reserve and on marker reliability in children complicates counselling. Study design, size, duration CHANCE is a prospective multicentric observational trial enrolling patients aged between 3 and 14 years at cancer diagnosis. We evaluated factors associated with the risk of future infertility such as hormonal levels, puberty and menstruation, and investigated the fertility preservation strategy. Parameters were assessed at screening, one year post-screening, end of the treatment, and during follow-up (FU) until 18 years of age. An interim analysis was planned considering the duration to reach the final endpoint. Participants/materials, setting, methods Between 2014 and 2023, 144 patients were enrolled. Patients were categorized in 3 groups by cumulative equivalent dose of cyclophosphamide (CED) received: &amp;lt;4000mg/m2 (low), 4000 to 8000mg/m2 (medium) and &amp;gt;8000 mg/m2 (high). Ninety-four patients with at least one year post-treatment follow-up were included in this analysis. Mean age at diagnosis was 8.4±4 years and 38% were prepubertal, with no difference between groups (p = 0.06 and 0.26, respectively). The median time of follow-up was 32.7 months. Main results and the role of chance Patients were categorized as low (n = 58), medium (n = 18) and high (n = 18) risk based on CED. Sarcoma were most frequent in high risk, while leukemia in low/medium risk groups (p &amp;lt; 0.0001). Fertility preservation was performed in 55.6%, 27.8% and 8.6% in high, medium and low risk group, respectively (p &amp;lt; 0.0001). The majority of them underwent ovarian tissue cryopreservation. POI was defined as induced puberty and/or FSH&amp;gt;25IU/l during FU. POI occurred in 10 out of 18 (55.6%) patients in high risk group, while in no patient in the low/medium risk groups except 1 with disease recurrence. POI was associated with high doses of chemotherapy (p &amp;lt; 0.0001) and increased age (p &amp;lt; 0.007). AMH levels significantly decreased in high and medium risk group during treatment. Recovery occurs in medium but not high risk groups (p = 0.84 and 0.02 between screening and values at 1-2 years and &amp;gt;3 years of FU using repeated measures analysis). Low AMH values (&amp;lt;0.5ng/ml) was observed at 2 years of FU in 14.3%, 28.6% and 69.2% of the patients in low, medium and high risk groups respectively. The impact of treatment, particularly in medium risk group, needs confirmation as around 35% of the patients were still prepubertal at the time of the analysis. Limitations, reasons for caution This is an interim analysis of a prospective trial designed to include 275 patients. Data should be cautiously interpreted due to not reaching the calculated optimal power population. Wider implications of the findings Our data confirmed that fertility preservation should be offered to all children and adolescent treated with high risk regimen. We did not provide evidence supporting its benefit for low/medium risk pre-pubertal children. For post-pubertal medium risk patients, fertility preservation may be considered during the FU based on patient decision. Trial registration number NCT02595255

New-Onset Postoperative Atrial Fibrillation and Preoperative Sleep in Cardiac Surgical Patients

BackgroundNew-onset postoperative atrial fibrillation is associated with adverse clinical outcomes in older adults. Poor preoperative sleep quality is a putative modifiable risk factor. The relationships between new-onset postoperative atrial fibrillation and preoperative sleep structure in older adults undergoing elective cardiac surgery were investigated at a single center. MethodsThis was a prespecified substudy within a prospective observational study of perioperative electroencephalographic markers (ClinicalTrials.gov; NCT03291626). We analyzed preoperative sleep recordings from 71 cardiac surgical patients aged ≥60 years without a prior history of atrial fibrillation. Overnight recordings were acquired using a consumer-grade headband and underwent manual sleep staging. Electroencephalographic slow wave activity (power in the 0.5-4 Hz frequency band) was computed in 1-minute intervals for non-rapid eye movement sleep stages. Associations between new-onset postoperative atrial fibrillation incidence and sleep measures were evaluated using univariate logistic regression models and multivariate logistic regression models including age and sex. ResultsNew-onset postoperative atrial fibrillation was present in 22 of 71 (31%) patients. A higher preoperative percentage of total sleep time in non-rapid eye movement stage 1 was associated with new-onset postoperative atrial fibrillation (median difference of 5.4%, P = .0002, Mann-Whitney U-test), independent of age and sex. No associations were observed between new-onset postoperative atrial fibrillation and other sleep metrics, including slow wave activity (all P > .05, Mann-Whitney U-test). ConclusionsExcess preoperative non-rapid eye movement stage 1 sleep, consistent with greater sleep fragmentation, is a potential modifiable target for mitigating new-onset postoperative atrial fibrillation risk in older adults undergoing elective cardiac surgery requiring cardiopulmonary bypass.

Assessing Residual Gastric Fluid Volume after Administering Diluted Oral Contrast until One Hour Prior to Anesthesia in Children: An Observational Cohort Study.

Background: Gastric fluid volume has been used as a surrogate marker for pulmonary aspiration risk in studies evaluating fasting protocol safety. This study measured residual gastric fluid volume in children using a protocol in which diluted oral contrast medium was administered up until one hour before anesthesia. Methods: This was a single-center prospective observational cohort trial of 70 children for elective abdominal/pelvic computed tomography (CT). Imaging was performed after diluted enteral contrast medium administration, beginning two hours before and ending at least one hour before induction. For each patient, gastric fluid volume was calculated using an image region of interest. The primary outcome measure was gastric fluid volume measured using the computed tomography image. Results: The median time from the end of contrast administration to imaging was 1.5 h (range: 1.1 to 2.2 h). Residual gastric volume, measured using CT was <0.4 mL/Kg in 33%; ≥0.4 mL/Kg in 67%; and ≥1.5 mL/Kg in 44% of patients. Residual gastric volumes measured using CT and aspiration were moderately correlated (Spearman's correlation coefficient = 0.41, p = 0.0003). However, the median residual gastric volume measured using CT (1.17, IQR: 0.22 to 2.38 mL/Kg) was higher than that of aspiration (0.51, IQR: 0 to 1.58 mL/Kg, p = 0.0008 on differences in paired measures). Three cases of vomiting were reported. No evidence of pulmonary aspiration was identified. Conclusions: Children who receive large quantities of clear fluid up to one hour before anesthesia can have a significant gastric residual volume.

Functional Outcomes After Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: Results From the Phase II North American Multicenter Prospective Observational Trial.

To investigate fecal incontinence and defecatory, urinary, and sexual functional outcomes after transanal total mesorectal excision (taTME). Proctectomy for rectal cancer may result in alterations in defecatory, urinary, and sexual function that persist beyond 12 months. The recent multicenter phase II taTME trial demonstrated the safety of taTME in patients with stage I to III tumors. Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence [Fecal Incontinence Quality of Life (FIQL), Wexner], defecatory function [Colorectal Functional Outcome (COREFO)], urinary function (International Prostate Symptom Score), and sexual function (Female Sexual Function Index-female, International Index of Erectile Function-male) were assessed preoperatively (PQ), 3 to 4 months postileostomy closure (FQ1), and 12 to 18 months post-taTME [postoperative questionnaire 2 (FQ2)]. Among 83 patients who responded at all 3 time points, FIQL, Wexner, and COREFO significantly worsened postileostomy closure. Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved, while FIQL depression and embarrassment did not change. International Prostate Symptom Score did not change relative to preoperative scores. For females, Female Sexual Function Index declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, International Index of Erectile Function declined with no change between FQ1 and FQ2. Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains improved by 12 months after ileostomy closure, without returning to preoperative status. Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient expectations and inform shared decision-making regarding taTME.