Antibiotic treatment versus appendicectomy for acute appendicitis in adults: an individual patient data meta-analysis.

Background: Randomised controlled trials (RCTs) have found antibiotics to be a feasible and safe alternative to appendicectomy in adults with imaging-confirmed acute appendicitis. However, patient inclusion criteria and outcome definitions vary greatly between RCTs. We aimed to compare antibiotics with appendicectomy for the treatment of acute appendicitis using individual patient data and uniform outcome definitions.

Economic analysis of hyperbaric oxygen therapy for the treatment of ischaemic diabetic foot ulcers.

Introduction: The aim was to determine the cost-effectiveness and cost-utility of additional hyperbaric oxygen therapy (HBOT) compared to standard care (SC) for ischaemic diabetic foot ulcers (DFUs) regarding limb salvage and health status.

Methods: An economic analysis was conducted, comprising cost-effectiveness and cost-utility analyses, with a 12-month time horizon, using data from the DAMO₂CLES multicentre randomised clinical trial. Cost-effectiveness was defined as cost per limb saved and cost-utility as cost per quality-adjusted life year (QALY).

Long-Term Outcomes of Early Surgery vs Endoscopy First in Chronic Pancreatitis: Follow-Up Analysis of the ESCAPE Randomized Clinical Trial.

Importance: Patients with painful chronic pancreatitis and a dilated pancreatic duct can be treated by early surgery or an endoscopy-first approach.

Objective: To compare long-term clinical outcomes of early surgery vs an endoscopy-first approach using follow-up data from the ESCAPE randomized clinical trial.

Design, Setting, And Participants: Between April 2011 and September 2018, 88 patients with painful chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach in 30 hospitals in the Netherlands collaborating in the Dutch Pancreatitis Study Group as part of the ESCAPE randomized clinical trial.

Incidence of early persistent pain after video-assisted thoracoscopic surgery: a single-centre prospective cohort study.

Background: Despite the benefits of video-assisted thoracoscopic surgery (VATS), postoperative acute pain and nerve injury are still present and contribute to early persistent and chronic pain. The purpose of this study is to describe the incidence of early persistent pain (EPP) after VATS, which remains unexplored, to enhance patient care and promote awareness among clinicians regarding this clinical condition.

Methods: A single-center prospective cohort study that included consecutive patients undergoing VATS between January 2021 and March 2023.

Combined strategy of upfront CTCA and optimal treatment for stable chest pain: rationale and design of the CLEAR-CAD trial.

Background: Patients with stable chest pain suspected of coronary artery disease (CAD) usually undergo multiple diagnostic tests to confirm or rule out obstructive CAD. Some tests may not effectively assess the presence of CAD, precluding optimal treatment. A diagnostic strategy of upfront computed tomography coronary angiography (CTCA) combined with optimal medical therapy (OMT) tailored to the extent of CAD may be superior to standard care in preventing major adverse cardiac events.

Digital consults in heart failure care: a randomized controlled trial.

Guideline-directed medical therapy (GDMT) has clear benefits on morbidity and mortality in patients with heart failure; however, GDMT use remains low. In the multicenter, open-label, investigator-initiated ADMINISTER trial, patients (n = 150) diagnosed with heart failure and reduced ejection fraction (HFrEF) were randomized (1:1) to receive usual care or a strategy using digital consults (DCs). DCs contained (1) digital data sharing from patient to clinician (pharmacotherapy use, home-measured vital signs and Kansas City Cardiomyopathy Questionnaires); (2) patient education via a text-based e-learning; and (3) guideline recommendations to all treating clinicians.

Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones: 5-Year Follow-Up of the SECURE Randomized Clinical Trial.

Importance: The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year.

Objective: To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up.

The UPDATE trial (UVB Phototherapy in Dermatology for ATopic Eczema): study protocol for a randomized controlled trial of narrowband UVB with optimal topical therapy versus optimal topical therapy in patients with atopic eczema.

Background: Narrowband ultraviolet B (NB-UVB) phototherapy is commonly prescribed for patients with moderate-to-severe atopic eczema (AE). The efficacy of NB-UVB, however, has not yet properly been established, as current evidence is of low certainty. Our aim is to assess the short-term and long-term (cost-)effectiveness and safety of NB-UVB in adult AE patients by performing a pragmatic, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial.

Clinical trial: The effectiveness of long-acting somatostatin analogue for output reduction of high-output intestinal fistula or small bowel enterostomy. A randomised controlled trial.

Background: High-output intestinal fistulas and small bowel enterostomies are associated with morbidity and mortality. Current standard treatment for output reduction consists of fluid and dietary restrictions and medical therapy. There is conflicting evidence regarding the use of somatostatin analogues for output reduction.

Cost-effectiveness of temperature monitoring to help prevent foot ulcer recurrence in people with diabetes: A multicenter randomized controlled trial.

Aims: Diabetes-related foot ulcers are common, costly, and frequently recur. Multiple interventions help prevent these ulcers. However, none of these have been prospectively investigated for cost-effectiveness.

Long-Term Follow-Up of the LEAP Study: Early Versus Delayed Levodopa in Early Parkinson's Disease.

Background And Objective: The Levodopa in EArly Parkinson's disease study showed no effect of earlier versus later levodopa initiation on Parkinson's disease (PD) progression over 80 weeks. We now report the effects over 5 years.

Methods: The Levodopa in EArly Parkinson's disease study randomly assigned patients to levodopa/carbidopa 300/75 mg daily for 80 weeks (early start) or to placebo for 40 weeks followed by levodopa/carbidopa 300/75 mg daily for 40 weeks (delayed start).

Impact of a Chronic Total Coronary Occlusion on the Incidence of Appropriate Implantable Cardioverter-Defibrillator Shocks and Mortality: A Substudy of the Dutch Outcome in ICD Therapy (DO-IT)) Registry.

Background: Chronic total coronary occlusions (CTO) substantially increase the risk for sudden cardiac death. Among patients with chronic ischemic heart disease at risk for sudden cardiac death, an implantable cardioverter defibrillator (ICD) is the favored therapy for primary prevention of sudden cardiac death. This study sought to investigate the impact of CTOs on the risk for appropriate ICD shocks and mortality within a nationwide prospective cohort.

Development and Validation of the Scoring System of Appendicitis Severity 2.0.

Importance: When considering nonoperative treatment in a patient with acute appendicitis, it is crucial to accurately rule out complicated appendicitis. The Atema score, also referred to as the Scoring System of Appendicitis Severity (SAS), has been designed to differentiate between uncomplicated and complicated appendicitis but has not been prospectively externally validated.

Objective: To externally validate the SAS and, in case of failure, to develop an improved SAS (2.

Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial.

Background: The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess the efficacy of laparoscopic appendectomy in addition to standard medical treatment in maintaining remission in UC patients.

Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring (SHEPHERD study): results of a randomized multicenter stepped wedge cluster trial.

Background: Vital signs measurements on the ward are performed intermittently. This could lead to failure to rapidly detect patients with deteriorating vital signs and worsens long-term outcome. The aim of this study was to test the hypothesis that continuous wireless monitoring of vital signs on the postsurgical ward improves patient outcome.

Digital consults to optimize guideline-directed therapy: design of a pragmatic multicenter randomized controlled trial.

Aims: Many heart failure (HF) patients do not receive optimal guideline-directed medical therapy (GDMT) despite clear benefit on morbidity and mortality outcomes. Digital consults (DCs) have the potential to improve efficiency on GDMT optimization to serve the growing HF population. The investigator-initiated ADMINISTER trial was designed as a pragmatic multicenter randomized controlled open-label trial to evaluate efficacy and safety of DC in patients on HF treatment.

MRI in addition to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): an international, multicentre, prospective, diagnostic accuracy trial.

Background: Guidelines are inconclusive on whether contrast-enhanced MRI using gadoxetic acid and diffusion-weighted imaging should be added routinely to CT in the investigation of patients with colorectal liver metastases who are scheduled for curative liver resection or thermal ablation, or both. Although contrast-enhanced MRI is reportedly superior than contrast-enhanced CT in the detection and characterisation of colorectal liver metastases, its effect on clinical patient management is unknown. We aimed to assess the clinical effect of an additional liver contrast-enhanced MRI on local treatment plan in patients with colorectal liver metastases amenable to local treatment, based on contrast-enhanced CT.

Pain management after pneumothorax surgery: intercostal nerve block or thoracic epidural analgesia.

Objectives: In patients undergoing video-assisted thoracoscopic surgery for pneumothorax, the benefits and risks of single-shot intercostal nerve block as loco-regional analgesia are not well known. We retrospectively compared the effectiveness of intercostal nerve blocks as a viable alternative to thoracic epidural analgesia (TEA) regarding pain control and enhanced recovery.

Methods: A retrospective multicentre analysis with single-centre propensity score matching was performed in patients undergoing video-assisted thoracoscopic surgery for pneumothorax receiving either TEA or intercostal nerve block.

Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial.

JCO Whether adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) might prevent peritoneal metastases after curative surgery for high-risk colon cancer is an ongoing debate. This study aimed to determine 5-year oncologic outcomes of the randomized multicenter COLOPEC trial, which included patients with clinical or pathologic T4N0-2M0 or perforated colon cancer and randomly assigned (1:1) to either adjuvant systemic chemotherapy and HIPEC (n = 100) or adjuvant systemic chemotherapy alone (n = 102). HIPEC was performed using a one-time administration of oxaliplatin (460 mg/m, 30 minutes, 42°C, concurrent fluorouracil/leucovorin intravenously), either simultaneously (9%) or within 5-8 weeks (91%) after primary tumor resection.