Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA):Study protocol for a randomized controlled trial

BACKGROUND: Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain. METHODS/DESIGN: The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base. DISCUSSION: The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain. TRIAL REGISTRATION: Clinicaltrials NCT0193616

Volvulus as a complication of chronic intestinal pseudo-obstruction syndrome

Chronic intestinal pseudo-obstruction syndrome (CIPS) is a severe motility disorder of the gastrointestinal tract that presents with continuous or recurrent symptoms and signs of intestinal obstruction without evidence of a structural lesion occluding the intestinal lumen. Mechanical obstruction might occur in these patients as well but is typically difficult to distinguish from an exacerbation of CIPS. We report two pediatric cases in which mechanical obstruction by volvulus mimicked an exacerbation of CIPS, requiring surgical intervention. Conclusion: Awareness of the possibility of true mechanical obstruction in CIPS patients during an exacerbation episode is needed, as this is a severe condition and usually requires surgical intervention

Radiographic rib fracture nonunion and association with fracture classification in adults with multiple rib fractures without flail segment:A multicenter prospective cohort study

Background: Rib fracture nonunion is a probable cause of chronic pain following chest trauma, although its prevalence remains unknown. The aims of this study were to determine rib fracture nonunion prevalence following nonoperative management and to determine if presence of nonunion was associated with the number of rib fractures, or the rib fracture classification of anatomical location, type, and displacement. Methods: This multicenter prospective cohort study included trauma patients with three or more fractured ribs but without a flail segment, who participated in the nonoperative management group of the FixCon trial between January 2019 and June 2022. The number and classification of rib fractures were assessed on trauma chest CT. Chest CTs conducted six months post-trauma were evaluated for the presence of nonunion. Radiological characteristics of nonunions were compared with normally healed rib fractures using the Mann-Whitney U, χ2 test, and Fisher's exact test as appropriate. A generalized linear model adjusted for multiple observations per patient when assessing the associations between nonunion and fracture characteristics. Results: A total of 68 patients were included with 561 post-traumatic fractures in 429 ribs. Chest CT after six months revealed nonunions in 67 (12 %) rib fractures in 29 (43 %) patients with a median of 2 (P25-P75 1–3) nonunions per patient. Nonunion was most commonly observed in ribs seven to 10 (20–23 %, p &lt; 0.001, adjusted p = 0.006). Nonunion occurred in 14 (5 %) undisplaced, 22 (19 %) offset, and 20 (23 %) displaced rib fractures (p &lt; 0.001). No statistically significant association between rib fracture type and nonunion was found. Conclusions: Forty-three percent of patients with multiple rib fractures had radiographic nonunion six months after trauma. Fractures in ribs seven to 10 and dislocated fractures had an increased risk of rib fracture nonunion.</p

Epidemiology of injuries, treatment (costs) and outcome in burn patients admitted to a hospital with or without dedicated burn centre (Burn-Pro)

INTRODUCTION: The Emergency Management of Severe Burns (EMSB) referral criteria have been implemented for optimal triaging of burn patients. Admission to a burn centre is indicated for patients with severe burns or with specific characteristics like older age or comorbidities. Patients not meeting these criteria can also be treated in a hospital without burn centre. Limited information is available about the organisation of care and referral of these patients. The aims of this study are to determine the burn injury characteristics, treatment (costs), quality of life and scar quality of burn patients admitted to a hospital without dedicated burn centre. These data will subsequently be compared with data from patients with<10% total bodysurface area (TBSA) burned who are admitted (or secondarily referred) to a burn centre. If admissions were in agreement with the EMSB, referral criteria will also be determined. METHODS AND ANALYSIS: In this multicentre, prospective, observational study (cohort study), the following two groups of patients will be followed: 1) all patients (no age limit) admitted with burn-related injuries to a hospital without a dedicated burn centre in the Southwest Netherlands or Brabant Trauma Region and 2) all patients (no age limit) with<10% TBSA burned who are primarily admitted (or secondarily referred) to the burn centre of Maasstad Hospital. Data on the burn injury characteristics (primary outcome), EMSB compliance, treatment, treatment costs and outcome will be collected from the patients' medical files. At 3 weeks and at 3, 6 and 12 months after trauma, patients will be asked to complete the quality of life questionnaire (EuroQoL-5D), and the patient-reported part of the Patient and Observer Scar Assessment Scale (POSAS). At those time visits, the coordinating investigator or research assistant will complete the observer-reported part of the POSAS. ETHICS AND DISSEMINATION: This study has been exempted by the medical r

Laparoscopic pyloromyotomy, the tail of the learning curve

The debate whether laparoscopic pyloromyotomy (LP) is superior to open pyloromyotomy (OP) remains actual. A recent review showed no benefit between the LP or OP, but in the studied randomized, controlled trials the learning curve was not addressed. Comparing LP including the learning curve with OP after the learning curve is questionable. In previous research, the learning curve of LP was analyzed. It was concluded that the plateau was reached after 35 procedures with a steep decrease in complications when comparing before and after 35 procedures. This study was designed to retrospectively analyze the results obtained in HPS patients after the learning curve in LP has been reached. The results will be compared with results of OP in HPS patients in the same period. A retrospective analysis in 106 OP and 57 LP was performed from September 2008 to June 2012. The overall complication rate in the OP group was significantly higher than in the LP group (18% vs. 3.5%, p = 0.012). Also there was a higher major complication rate in the OP group (10.4% vs. 1.7%, p = 0.045). The median time to operate was with 28.5 min in OP and 30.0 min in LP (not significant), whereas the LOS was 2 days in both groups (not significant). In this study, a further decline in overall and major complications after the learning curve is seen in the LP group, the tail of the learning curve. The debate whether LP is superior to OP is not finished as long as it is not clear whether the minimally invasive operation is beyond the initial or tail of the learning curv

Use of a multi-instrument access device in abdominoperineal resections

Background: Laparoscopic colorectal surgery results in less post-operative pain, faster recovery, shorter length of stay and reduced morbidity compared with open procedures. Less or minimally invasive techniques have been developed to further minimise surgical trauma and to decrease the size and number of incisions. This study describes the safety and feasibility of using an umbilical multi-instrument access (MIA) port (Olympus TriPort+) device with the placement of just one 12-mm suprapubic trocar in laparoscopic (double-port) abdominoperineal resections (APRs) in rectal cancer patients. Patients and Methods: The study included 20 patients undergoing double-port APRs for rectal cancer between June 2011 and August 2013. Preoperative data were gathered in a prospective database, and post-operative data were collected retrospectively. Results: The 20 patients (30% female) had a median age of 67 years (range 46-80 years), and their median body mass index (BMI) was 26 kg/m2 (range 20-31 kg/m2). An additional third trocar was placed in 2 patients. No laparoscopic procedures were converted to an open procedure. Median operating time was 195 min (range 115-306 min). A radical resection (R0 resection) was achieved in all patients, with a median of 14 lymph nodes harvested. Median length of stay was 8 days (range 5-43 days). Conclusion: Laparoscopic APR using a MIA trocar is a feasible and safe procedure. A MIA port might be of benefit as an extra option in the toolbox of the laparoscopic surgeon to further minimise surgical trauma