Development and external validation of preoperative clinical prediction models for postoperative outcomes including preoperative aerobic fitness in patients approaching elective colorectal cancer surgery.

INTRODUCTION: Preoperative aerobic fitness is associated with postoperative outcomes after elective colorectal cancer (CRC) surgery. This study aimed to develop and externally validate two clinical prediction models incorporating a practical test to assess preoperative aerobic fitness to distinguish between patients with and without an increased risk for 1) postoperative complications and 2) a prolonged time to in-hospital recovery of physical functioning after elective colorectal cancer (CRC) surgery. MATERIALS AND METHODS: Models were developed using prospective data from 256 patients and externally validated using prospective data of 291 patients. Postoperative complications were classified according to Clavien-Dindo. The modified Iowa level of assistance scale (mILAS) was used to determine time to postoperative in-hospital physical recovery. Aerobic fitness, age, sex, body mass index, American Society of Anesthesiologists (ASA) classification, neoadjuvant treatment, surgical approach, tumour location, and preoperative haemoglobin level were potential predictors. Areas under the curve (AUC), calibration plots, and Hosmer-Lemeshow tests evaluated predictive performance. RESULTS: Aerobic fitness, sex, age, ASA, tumour location, and surgical approach were included in the final models. External validation of the model for complications and postoperative recovery presented moderate to fair discrimination (AUC 0.666 (0.598-0.733) and 0.722 (0.651-0.794), respectively) and good calibration. High sensitivity and high negative predictive values were observed in the lower predicted risk categories (<40 %). CONCLUSION: Both models identify patients with and without an increased risk of complications or a prolonged time to in-hospital physical recovery. They might be used for improving patient-tailored preoperative risk assessment and targeted and cost-effective application of prehabilitation interventions.

Societal costs before and up to 1 year after the first fracture liaison service visit in patients requiring anti-osteoporosis treatments.

This study aimed to estimate societal and healthcare costs incurred before and 1 year after the first fracture liaison services (FLS) visit and to explore differences in fracture type. All costs after 1 year significantly decreased compared to costs preceding the first visit. Fracture type did not significantly affect costs. INTRODUCTION: Limited literature is available on resource utilization and costs of patients visiting fracture liaison services (FLS). This study aimed to estimate the societal and healthcare costs incurred by patients with a recent fracture requiring anti-osteoporosis medication before and 1 year after the first FLS visit and to explore differences according to fracture type. METHODS: Resource utilization was collected through a self-reported questionnaire with a 4-month recall on health resource utilization and productivity losses immediately following the first FLS visit, and 4 and 12 months later. Unit costs derived from the national Dutch guideline for economic evaluations were used to compute societal and healthcare costs. Linear mixed-effect models, adjusted for confounders, were used to analyze societal and healthcare costs over time as well as the effect of fracture type on societal and healthcare costs. RESULTS: A total of 126 patients from two Dutch FLS centers were included, of whom 72 sustained a major fracture (hip, vertebral, humerus, or radius). Societal costs in the 4 months prior to the first visit (€2911) were significantly higher compared to societal costs 4 months (€711, p-value = 0.009) and 12 months later (€581, p-value = 0.001). Fracture type did not have a significant effect on total societal or healthcare costs. All costs 12 months after the initial visit were numerically lower for major fractures compared to others. CONCLUSION: Societal and healthcare costs in the year following the first FLS visit significantly decreased compared to those costs preceding the first visit.

Table 0; documenting the steps to go from clinical database to research dataset.

OBJECTIVES: Data-driven decision support tools have been increasingly recognized to transform health care. However, such tools are often developed on predefined research datasets without adequate knowledge of the origin of this data and how it was selected. How a dataset is extracted from a clinical database can profoundly impact the validity, interpretability and interoperability of the dataset, and downstream analyses, yet is rarely reported. Therefore, we present a case study illustrating how a definitive patient list was extracted from a clinical source database and how this can be reported. STUDY DESIGN AND SETTING: A single-center observational study was performed at an academic hospital in the Netherlands to illustrate the impact of selecting a definitive patient list for research from a clinical source database, and the importance of documenting this process. All admissions from the critical care database admitted between January 1, 2013, and January 1, 2023, were used. RESULTS: An interdisciplinary team collaborated to identify and address potential sources of data insufficiency and uncertainty. We demonstrate a stepwise data preparation process, reducing the clinical source database of 54,218 admissions to a definitive patient list of 21,553 admissions. Transparent documentation of the data preparation process improves the quality of the definitive patient list before analysis of the corresponding patient data. This study generated seven important recommendations for preparing observational health-care data for research purposes. CONCLUSION: Documenting data preparation is essential for understanding a research dataset originating from a clinical source database before analyzing health-care data. The findings contribute to establishing data standards and offer insights into the complexities of preparing health-care data for scientific investigation. Meticulous data preparation and documentation thereof will improve research validity and advance critical care.

De-escalation of axillary treatment in the event of a positive sentinel lymph node biopsy in cT1-2 N0 breast cancer treated with mastectomy: nationwide registry study (BOOG 2013-07).

BACKGROUND: Trials have demonstrated the safety of omitting completion axillary lymph node dissection in patients with cT1-2 N0 breast cancer operated with breast-conserving surgery who have limited metastatic burden in the sentinel lymph node. The aim of this registry study was to provide insight into the oncological safety of omitting completion axillary treatment in patients operated with mastectomy who have limited-volume sentinel lymph node metastasis. METHODS: Women diagnosed in 2013-2014 with unilateral cT1-2 N0 breast cancer treated with mastectomy, with one to three sentinel lymph node metastases (pN1mi-pN1a), were identified from the Netherlands Cancer Registry, and classified by axillary treatment: no completion axillary treatment, completion axillary lymph node dissection, regional radiotherapy, or completion axillary lymph node dissection followed by regional radiotherapy. The primary endpoint was 5-year regional recurrence rate. Secondary endpoints included recurrence-free interval and overall survival, among others. RESULTS: In total, 1090 patients were included (no completion axillary treatment, 219 (20.1%); completion axillary lymph node dissection, 437 (40.1%); regional radiotherapy, 327 (30.0%); completion axillary lymph node dissection and regional radiotherapy, 107 (9.8%)). Patients in the group without completion axillary treatment had more favourable tumour characteristics and were older. The overall 5-year regional recurrence rate was 1.3%, and did not differ significantly between the groups. The recurrence-free interval was also comparable among groups. The group of patients who did not undergo completion axillary treatment had statistically significantly worse 5-year overall survival, owing to a higher percentage of non-cancer deaths. CONCLUSION: In this registry study of patients with cT1-2 N0 breast cancer treated with mastectomy, with low-volume sentinel lymph node metastasis, the 5-year regional recurrence rate was low and comparable between patients with and without completion axillary treatment.

Previous Exercise Levels and Outcome in Patients with New Atrial Fibrillation: 'Past Achievements Do Not Predict the Future'.

INTRODUCTION: Long-term endurance exercise is suspect to elevate the risk of atrial fibrillation (AF),but little is known about cardiovascular outcome and disease progression in this subgroup of AF patients. We investigated whether previous exercise level determines cardiovascular outcome. METHODS: In this post hoc analysis of the RACE 4 randomized trial, we analyzed all patients with a completed questionnaire on sports participation. Three subgroups were made based on lifetime sports hours up to randomization and previous compliance to the international physical activity guidelines. High lifetime hours of high dynamic activity patients were defined as more than 150 min/week of high intense physical exercise. The primary endpoint was a composite of cardiovascular death and hospital admissions. RESULTS: A total of 879 patients were analyzed, divided in 203 high lifetime hours of high dynamic activity -, 192 high lifetime hours of activity- and 484 low lifetime hours of activity patients. Over a mean follow up of 36 months (±14), the primary endpoint occurred in 61 out of 203 (30%) high lifetime hours of high dynamic activity -, 53 out of 192 (27%) high lifetime hours of activity- and 135 out of 484 low lifetime hours of activity patients (28%) (p = 0.74). During follow up 42 high lifetime hours of high dynamic activity- (35%), 43 high lifetime hours of activity- (32%) and 104 low lifetime hours of activity patients (34%) with paroxysmal AF received electrical or chemical cardioversion or atrial ablation (p = 0.90). CONCLUSIONS: In patients included in the RACE 4, there appears to be no relation between previous activity levels and cardiovascular outcome and the need for electrical or chemical cardioversion or atrial ablation. Cardiovascular outcome was driven by AF related arrhythmic events.

Left atrial function of patients with atrial fibrillation undergoing thoracoscopic hybrid ablation.

OBJECTIVES: Thoracoscopic hybrid ablation is an effective and safe rhythm control strategy for patients with complex forms of atrial fibrillation. Its effect on left atrial function has not yet been studied. METHODS: In a retrospective single-centre analysis of patients undergoing thoracoscopic hybrid ablation, the left atrial emptying fraction was calculated using the biplane modified Simpson method in the apical 2- and 4-chamber views on transthoracic echocardiography. Left atrial strain (reservoir, conduction and contractility) was quantified using dedicated software. RESULTS: Sixty-seven patients were included (mean age 64 years, long-standing persistent atrial fibrillation in 69%, median atrial fibrillation history duration 64 months). At baseline, left atrial function and contractility were poor. The reservoir and contractile strain improved postprocedure compared to baseline [15 (standard deviation (SD): 8) and 17 (SD: 6); P = 0.013; 3 (SD: 5) and 4 (SD: 4), P = 0.008], whereas the left atrial volume indexed to the body surface area was reduced [51 ml/m2 (SD: 14) and 47 ml/m2 (SD: 18), P = 0.0024]. In patients with preoperative (long-standing) persistent atrial fibrillation and in patients with rhythm restoration, improvements in the emptying fraction, (reservoir and contractile) strain and the left ventricular ejection fraction were observed, whereas the left atrial volume decreased (P < 0.05). CONCLUSIONS: In this cohort of patients with severely diseased left atria, improvement in left atrial contractility and in the emptying fraction after thoracoscopic hybrid ablation for atrial fibrillation in patients with persistent atrial fibrillation is mainly due to rhythm restoration. Interestingly, the procedure itself also results in improved left atrial reservoir strain and reversed left atrial remodelling by reducing left atrial volume.

The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool; a validity and reliability study.

INTRODUCTION: Follow-up care after treatment for colorectal cancer (CRC) is increasingly focused on health-related quality of life (HRQoL) and functional outcomes. The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool is developed to measure these outcomes and support patient-oriented care. The tool comprises items assessing burden of disease and lifestyle parameters. It consists of a generic module combined with one of the three CRC specific modules. The objective of this study is to assess the construct validity and reliability of the items of the ABCRC-tool. METHODS: Patients who were receiving follow-up care after surgical CRC treatment were invited to complete the ABCRC-tool together with other validated patient-reported outcome measures (PROMs). Construct validity was assessed by testing expected correlations between items of the ABCRC-tool and domains of other PROMs and by examining predefined hypotheses regarding differences in subgroups of patients. Patients completed the ABCRC-tool twice, with 8 days apart, to evaluate its reliability. RESULTS: In total, 177 patients participated (64% male) with a mean age of 67 years (range 33-88). The colon, rectum and stoma module were completed by subsequently 89, 53 and 35 patients. Most items correlated as expected with anticipated domains of the EORTC QLQ-C30 or EORTC QLQ-CR29 (all p-values <0.05). Furthermore, the ABCRC-tool could discriminate between subgroups of patients. The intraclass correlation coefficient (ICC) was good (>0.70) for most items, indicating good reliability. CONCLUSION: The ABCRC-tool is a valid and reliable instrument that is ready for use in a clinical setting to support personalized follow-up care after CRC treatment.

Predicting Delayed In-Hospital Recovery of Physical Function After Total Knee Arthroplasty.

Objective: To identify patients at high risk of delayed in-hospital functional recovery after knee replacement surgery by developing and validating a prediction model, including a combination of preoperative physical fitness parameters and patient characteristics. Design: Retrospective cohort study using binary logistic regression. Setting: University hospital, orthopedic department. Participants: 260 adults (N=260) (≥18y) with knee osteoarthritis awaiting primary unilateral total knee arthroplasty and assessed during usual care between 2016 and 2020. Intervention: Not applicable. Main Outcome Measures: Time to reach in-hospital functional independence (in days), measured by the modified Iowa Level of Assistance Scale. A score of 0 means completely independent. Potential predictor variables are a combination of preoperative physical fitness parameters and patient characteristics. Results: Binary logistic regression modeling was applied to develop the initial model. A low de Morton Mobility Index (DEMMI), walking aid use indoors, and a low handgrip strength (HGS) were the most important predictors of delayed in-hospital recovery. This model was internally validated and had an optimism-corrected R2 of 0.07 and an area under curve of 61.2%. The probability of a high risk of delayed in-hospital recovery is expressed by the following equation:Phighrisk=(1/(1+e(-(2.638-0.193×DEMMI+0.879×indoorwalkingaid-0.007×HGS))))×100%. Conclusions: The model has a low predictive value and a poor discriminative ability. However, there is a positive association between preoperative physical fitness and postoperative recovery of physical function. The validity of our model to distinguish between high and low risk, based on preoperative fitness values and patient characteristics, is limited.

Active plasma renin concentration throughout healthy and complicated pregnancy: a systematic review and meta-analysis.

BACKGROUND: Pregnancy is characterized by profound circulatory changes and compensatory adjustments in the renin-angiotensin-aldosterone system (RAAS). Differences in regulatory response may antedate or accompany vascular complicated pregnancy. We performed a systematic review and meta-analysis to delineate the trajectory of active plasma renin concentration (APRC) in healthy pregnancy and compare this to complicated pregnancy. METHODS: We performed a systematic review and meta-analysis on APRC during normotensive and hypertensive pregnancies, using PubMed (NCBI) and Embase (Ovid) databases. We included only studies reporting measurements during pregnancy together with a nonpregnant reference group measurement. Risk of bias was assessed with QUIPS. Ratio of the mean (ROM) and 95% confidence intervals (CI) of APRC values between pregnant and nonpregnant women were estimated for predefined intervals of gestational age using a random-effects model. Meta-regression was used to analyze APRC over time. RESULTS: In total, we included 18 studies. As compared to nonpregnant, APRC significantly increased as early as the first weeks of healthy pregnancy and stayed increased throughout the whole pregnancy (ROM 2.77; 95% CI 2.26-3.39). APRC in hypertensive complicated pregnancy was not significantly different from nonpregnancy (ROM 1.32; 95% CI 0.97-1.80). CONCLUSION: Healthy pregnancy is accompanied by a profound rise in APRC in the first trimester that is maintained until term. In hypertensive complicated pregnancy, this increase in APRC is not observed.

The efficacy of sensory nerve coaptation in DIEP flap breast reconstruction - Preliminary results of a double-blind randomized controlled trial.

BACKGROUND: Sensory nerve coaptation has great potential to restore sensation after autologous breast reconstruction. However, blinded and randomized studies are lacking. We therefore present the preliminary results of our ongoing double-blinded randomized controlled trial that compares sensory recovery of innervated versus non-innervated DIEP flaps. METHODS: Patients who underwent DIEP flap breast reconstruction between July 2019 and February 2022 were included and randomized. The anterior cutaneous branch of the second or third intercostal nerve was coapted. Pre- and postoperative sensory testing was performed with Semmes-Weinstein Monofilaments, Pressure Specified Sensory Device, and a thermostimulator, for tactile and temperature thresholds. RESULTS: This interim analysis comprised 41 patients contributing 29 innervated and 38 non-innervated breasts. At 24 months of follow-up, the mean monofilament value of the flap skin was lower in innervated than in non-innervated flaps (4.48 vs. 5.20, p = 0.003). Touch thresholds were lower the center of the innervated flaps (47.8 vs. 71.2 g/mm2, p = 0.036), and heat pain was more often imperceptible in non-innervated flaps (42.1% vs. 10.3%, p = 0.004). No adverse events were associated with sensory nerve coaptation. CONCLUSIONS: These preliminary results indicate superior sensibility and recovery of protective sensation in innervated compared with non-innervated DIEP flaps. Although the results of the completed trial must be awaited to establish the full clinical impact, including highly anticipated quality of life outcomes, we encourage continuation of scientific and clinical efforts in this promising technique.

Prediction of poor exposure in endoscopic mitral valve surgery using computed tomography.

OBJECTIVES: In endoscopic mitral valve surgery, optimal exposure is crucial. This study aims to develop a predictive model for poor mitral valve exposure in endoscopic surgery, utilizing preoperative body profiles and computed tomography images. METHODS: We enrolled patients undergoing endoscopic mitral valve surgery with available operative video and preoperative computed tomography. The degree of valve exposure was graded into 0 (excellent), 1 (fair), 2 (poor) and 3 (very poor). Intrathoracic dimensions-anteroposterior width (chest anteroposterior) and left-to-right width (chest width) of the thorax, height of right hemi-thorax (chest height), angle between the left ventricular axis and the horizontal plane (left ventricle apex angle), heart width, level of diaphragm in midline, and vertical distance between the midline diaphragm level and the highest top of the right diaphragm (Δdiaphragm) were measured. RESULTS: Among 263 patients, mitral valve exposure was graded as 0 in 131 (49.8%), 1 in 72 (27.4%), 2 in 46 (17.5%) and 3 in 14 (5.3%). Body mass index, chest width, left ventricle apex angle, heart width and Δdiaphragm were identified as independent predictors of grades 2 and 3 exposure by stepwise logistic regression analysis, with an area under the receiver operating characteristic curve of 0.822 (P < 0.001). Univariate logistic regression for grade 3 exposure prediction revealed that Δdiaphragm had the largest area under the curve (0.826, P < 0.001). CONCLUSIONS: Poor mitral valve exposure occurred in approximately one-fourth of the endoscopic surgery series and might be predicted preoperatively using body mass index and computed tomography measurements to help determine the surgical approach.

Patient Impression of Improvement 1 year After Sacrospinous Hysteropexy Versus Vaginal Hysterectomy in Women with Pelvic Organ Prolapse Stage 2 or Higher.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcomes are relevant outcomes in studies on pelvic organ prolapse (POP) surgery, as anatomical recurrence alone does not have a significant correlation with perceived improvement. In the present study, the patient's impression of improvement after 1 year is studied after vaginal hysterectomy (VH) versus sacrospinous hysteropexy (SSH) in large cohorts from daily clinical practice. We hypothesize that there is no difference between the groups. METHODS: This is a secondary analysis on prospectively collected data in a multicenter cohort of patients who underwent VH or SSH for symptomatic POP. All patients had a POP-Q stage ≥ 2 in at least one compartment at baseline and were treated with VH or SSH between 2002 and 2019. The primary outcome was the patient-reported score on the patient global impression of improvement index (PGI-I) 1 year after surgery. The secondary outcome was a composite outcome of surgical success, defined as the absence of recurrent POP beyond the hymen with bothersome bulge symptoms and/or repeat surgery. RESULTS: A total of 378 women (196 VH and 182 SSH) were included. The median score on the PGI-I did not differ between VH and SSH. At 1 year post-operatively, 77 women after VH (73%) and 77 women after SSH (75%) considered their condition (very) much improved (p = 0.86). There was no difference in composite outcome of surgical success (126 out of 137 women [92%] after VH, 118 out of 125 women [94%] after SSH; p = 0.44). CONCLUSIONS: Our study shows that there was no difference in the type of surgery, VH or SSH, with regard to the patient's impression of improvement 1 year postoperatively in a large cohort from daily clinical practice.

Intravenous thrombolysis for ischemic stroke in the posterior circulation: A systematic review and meta-analysis.

OBJECTIVES: Intravenous thrombolysis (IVT) is recommended in patients with ischemic stroke in the anterior and posterior circulation. Neurological outcomes due to posterior circulation strokes (PCS) without treatment remain poor. Our aim was to overview the literature on outcomes of IVT and conservative treatment in PCS, based on a systematic review and meta-analysis. METHODS: A systematic literature search was performed on February 27th 2023. Outcome measures included favorable functional outcome at 90 days (modified Rankin Scale [mRS] 0-2), mortality at 90 days, and symptomatic intracranial hemorrhages (sICH). Weighted averages with DerSimonian-Laird approach was used to analyze the data. Subgroup analyses by time window were performed: standard time window (<4.5 hours after symptom onset) and extended time window (>4.5 hours). Analyses were performed using R. RESULTS: Eight prospective and four retrospective cohort studies were included (n = 1589 patients); no studies with conservative treatment were eligible. The pooled weighted probability regarding favorable functional outcome after IVT was 63 % (95 %CI:0.45-0.78), for mortality 19 % (95 %CI:0.11-0.30), and for sICH 4 % (95 %CI:0.02-0.07). Subgroup analyses showed higher probabilities on achieving favorable functional outcomes for patients treated in the standard (77 %; 95 %CI:0.62-0.88) compared to the extended time window (38 %; 95 %CI:0.29-0.48) with RR = 1.93 (95 %CI:1.66-2.24). Lower probabilities regarding mortality at 90 days and sICH were seen in patients treated in standard compared to extended time window (RR = 0.42, 95 %CI:0.34-0.51 and RR = 0.27, 95 %CI:0.16-0.45, respectively). CONCLUSIONS: IVT in patients with PCS seems to be safe and effective in standard and extended time window. The effect of IVT is higher in the standard time window.

Germinal centres within tumour positive sentinel lymph nodes are positively associated with tumour infiltrating lymphocytes and tertiary lymphoid structures in breast cancer.

BACKGROUND: Stromal tumour infiltrating lymphocytes (sTILs) and presence of tertiary lymphoid structures have been proposed as indicators of tumour-related immune response in breast cancer. An increased number of germinal centres (GCs) in lymph nodes is considered a sign of humoral immune reactivity. AIMS: It is unclear whether a relationship exists between number and size of GCs within tumour positive sentinel lymph nodes (SLNpos), sTILs and tertiary lymphoid structures within matched primary breast cancer and breast cancer subtype. METHODS: Axillary SLNpos from 175 patients with breast cancer were manually contoured in digitized haematoxylin and eosin stained sections. Total SLN area, GC number and GC area were measured in SLNpos with the largest metastatic area. To correct for SLN size, GC number and GC area were divided by SLN area. sTILs and presence of tertiary lymphoid structures were assessed in the primary breast cancer. RESULTS: A higher GC number and larger GC area were found in patients with high sTILs (≥2%) (both P < 0.001) and in patients with presence of tertiary lymphoid structures (PGC number = 0.034 and PGC area = 0.016). Triple negative and HER2-positive (N = 45) breast cancer subtypes had a higher GC number and higher sTILs compared to hormone receptor positive, HER2-negative breast cancer (N = 130) (PGC number < 0.001 and PsTILs= 0.001). CONCLUSION: This study suggests GCs measured within SLNpos might be useful indicators of the humoral anti-tumour immune response in breast cancer. Future studies are needed investigating underlying biological mechanisms and prognostic value of GCs in SLNs.

Drain-free mastectomy and flap fixation: The interim analysis of a randomized controlled noninferiority trial.

INTRODUCTION: Flap fixation after mastectomy has proven to be one of the most promising solutions to reduce seroma formation. Drain placement remains standard practice in many clinics, even though this may be redundant after flap fixation. METHODS: This is a prospective randomized controlled trial comparing mastectomy and wound closure using flap fixation with or without drain placement. The primary outcome measure was clinically significant seroma (CSS) incidence. The aim of this interim analysis was to assess the assumptions for the sample size calculation and to provide preliminary results. RESULTS: Between July 2020 and January 2023, 112 patients were included. CSS incidence was 9.1% in the drain group and 21% in the no-drain group. In total, 10 patients were lost to follow-up. These numbers are similar to the ones used for the sample size calculation. In the drain group, three patients required interventions for wound complications compared to nine in the no-drain group (odds ratio: 3.612 [95% confidence interval: 0.898-14.537]). CONCLUSION: The sample size calculation seems to be correct and no protocol amendments are necessary. Current preliminary results show no significant differences in CSS incidence. Complete results should be awaited to draw a well-powered conclusion regarding drain policy after mastectomy.

A Randomized Controlled Trial Using Epidural Analgesia for Pain Relief After Lumbar Interlaminar Decompressive Spine Surgery: The RAPID trial.

STUDY DESIGN: Prospective, double-blind randomized controlled trial. OBJECTIVE: If an intraoperative single bolus of epidural bupivacaine can result in less postoperative pain following lumbar spinal decompression surgery. SUMMARY OF BACKGROUND DATA: Adequate postoperative pain management following lumbar spinal decompression surgery is important, as it will lead to early mobilization, less complications, and a shorter hospital stay. Opioid consumption should be limited due to their frequently accompanied side effects and their addictive nature. During the final phase of lumbar decompression surgery, the epidural space becomes easily accessible. This might be an ideal moment for surgeons to administer an epidural bolus of analgesia as a safe and effective method for postoperative pain relief. MATERIALS AND METHODS: In this trial, we compared a single intraoperative bolus of epidural analgesia using bupivacaine 0.25% to placebo (NaCl 0.9%) and its effect on postoperative pain following lumbar spinal decompression surgery. The primary outcome was the difference in Numeric (Pain) Rating Scale between the intervention and placebo groups during the first 48 hours after surgery. RESULTS: Both the intervention group and the placebo group consisted of 20 randomized patients (N=40). Statistically significant lower mean Numeric (Pain) Rating Scale pain scores were observed in the intervention group in comparison with the control group (main effect group: -2.35±0.77, P =0.004). The average pain score was lower in the intervention group at all postoperative time points. No study-related complications occurred. CONCLUSION: This randomized controlled trial shows that administrating a bolus of intraoperative epidural bupivacaine is a safe and effective method for reducing early postoperative pain following lumbar decompression surgery.

Seroma formation after mastectomy: A systematic review and network meta-analysis of different flap fixation techniques.

Flap fixation is the most promising solution to prevent seroma formation after mastectomy. In this systematic review with network meta-analysis (NMA), three different techniques were compared. The NMA included 25 articles, comprising 3423 patients, and revealed that sutures are superior to tissue glue in preventing clinically significant seroma. In addition, running sutures seemed to be superior to interrupted sutures. An RCT comparing these suture techniques seems necessary, given the quality and nature of existing literature.

A 52-mg levonorgestrel-releasing intrauterine system vs bipolar radiofrequency nonresectoscopic endometrial ablation in women with heavy menstrual bleeding: long-term follow-up of a multicenter randomized controlled trial.

BACKGROUND: The symptom of heavy menstrual bleeding has a substantial impact on professional, physical, and social functioning. In 2021, results from a randomized controlled trial comparing a 52-mg levonorgestrel-releasing intrauterine system and radiofrequency nonresectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during 2-year follow-up. However, long-term results are also relevant for both patients and healthcare providers. OBJECTIVE: This study aimed to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52-mg levonorgestrel-releasing intrauterine system or radiofrequency nonresectoscopic endometrial ablation. STUDY DESIGN: This study was a long-term follow-up study of a multicenter randomized controlled trial (MIRA trial), in which women were allocated to either a 52-mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency nonresectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out 6 questionnaires. The primary outcome was the reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function, and patient satisfaction. RESULTS: From the 270 women who were randomized in the original trial, 196 (52-mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency nonresectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range, 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52-mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency nonresectoscopic endometrial ablation group (relative risk, 1.39; 95% confidence interval, 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher among patients with a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system compared with radiofrequency nonresectoscopic endometrial ablation (35.3% [30/85] vs 19.1% [18/94]; relative risk, 1.84; 95% confidence interval, 1.11-3.10). However, the hysterectomy rate was similar (11.8% [10/94] in the 52-mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency nonresectoscopic endometrial ablation group; relative risk, 0.65; 95% confidence interval, 0.32-1.34). Most reinterventions occurred during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function, and patient satisfaction. CONCLUSION: The overall risk of reintervention after long-term follow-up was not different between women treated according to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system and those treated using a strategy starting with radiofrequency nonresectoscopic endometrial ablation. However, women allocated to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system had a higher risk of surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies were effective in lowering menstrual blood loss over the long term. The results of this long-term follow-up study can support physicians in optimizing the counseling of women with heavy menstrual bleeding, thus promoting informed decision-making regarding choice of treatment.

Effects of remote coaching following supervised exercise oncology rehabilitation on physical activity levels, physical fitness, and patient-reported outcomes: a randomised controlled trial.

BACKGROUND: Studies have shown that cancer survivors experience difficulties maintaining physical activity levels after participation in a supervised exercise rehabilitation program. This study aimed to assess the effectiveness of a six-month remote coaching intervention, following a supervised exercise oncology rehabilitation program on maintenance of PA levels; and improvement of aerobic capacity, muscle strength and patient-reported outcomes in cancer survivors. METHODS: Ninety-seven participants from a Dutch University Hospital's exercise rehabilitation program were randomised to the COACH group (n = 46), receiving 6 months of remote coaching after completing the exercise program, or the CONTROL group (n = 50), receiving no additional intervention. Assessment of PA levels; sedentary time; aerobic capacity; muscle strength; fatigue; health-related quality of life (HRQoL); level of anxiety and depression; and return to work (RTW) rates were conducted at baseline (T0) and six months later (T1). Multiple linear regression was used for between-group statistical comparisons of all outcomes measures. Mean differences at T1 were estimated with corresponding 95% confidence intervals (95%CI). RESULTS: No significant between-group differences were observed for all outcomes at T1. An adjusted mean difference in weekly PA of 45 min (95%CI -50;140) was observed between the COACH group and the CONTROL group, favouring the COACH group, yet lacking statistical or clinical significance. CONCLUSIONS: Our six-month remote coaching intervention did not notably improve PA levels; sedentary time; aerobic capacity; muscle strength; HRQoL; fatigue; anxiety and depression symptoms and RTW rates after participation in a supervised exercise oncology program. Although the participants who received coaching showed slightly higher levels of PA, these differences were not significant. More research is needed to identify patients in need for follow-up interventions following supervised exercise program and to investigate the effectiveness of remote coaching interventions in these patients. TRIAL REGISTRATION: Dutch Trial Register NL7729, registered 13 may 2019, https://trialsearch.who.int/Trial2.aspx?TrialID=NL7729 .