Author response to : Comment on: DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial

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DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND) : open-label, randomized clinical trial

Background: Mild appendicitis may resolve spontaneously. The use of CT may lead to an overdiagnosis of uncomplicated appendicitis. The aims of this study were to examine whether early imaging results in more patients being diagnosed with acute appendicitis than initial observation, and to study the safety and feasibility of score-based observation compared with imaging in patients with equivocal signs of appendicitis. Methods: Patients with suspected appendicitis with symptoms for fewer than 24 h and an Adult Appendicitis Score of 11-15 were eligible for this trial. After exclusions, patients were randomized openly into two equal-sized groups: imaging and observation. Patients in the imaging group had ultrasound imaging followed by CT when necessary, whereas those in the observation group were reassessed after 6-8 h with repeated scoring and managed accordingly. The primary outcome was the number of patients requiring treatment for acute appendicitis within 30 days. Results: Ninety-three patients were randomized to imaging and 92 to observation; after exclusions, 93 and 88 patients respectively were analysed. In the imaging group, more patients underwent treatment for acute appendicitis than in the observation group: 72 versus 57 per cent (difference 15 (95 per cent c.i. 1 to 29) per cent). This suggests that patients with spontaneously resolving appendicitis were not diagnosed or treated in the observation group. Some 55 per cent of patients in the observation group did not need diagnostic imaging within 30 days after randomization. There was no difference in the number of patients diagnosed with complicated appendicitis (4 versus 2 per cent) or negative appendicectomies (1 versus 1 per cent) in the imaging and observation groups. Conclusion: Score-based observation of patients with early equivocal appendicitis results in fewer patients requiring treatment for appendicitis.Peer reviewe

Long-term re-procedure rate after mid-urethral slings for stress urinary incontinence

Introduction and hypothesis Long-term safety concerns have risen over the mid-urethral sling operation (MUS) for stress urinary incontinence (SUI), which in some countries has led to litigations and even suspending MUS insertions. We examined the long-term re-procedure rate after MUS operations. The main outcome was re-procedures for SUI. The secondary outcome was surgical interventions due to complications. Methods We analysed a retrospective population cohort of 3531 women with MUS operations in 2000-2006 and followed them up until 31 December 2016. Data were collected from a national hospital register and from hospital patient records. Results The median follow-up time was 13 years (IQR 11.6-14.8) for the 3280 women with a retropubic MUS (RP-MUS) and 11 years (IQR 10.3-11.9) for the 245 women with a transobturator MUS (TO-MUS). The cumulative number of re-procedures for SUI was 16 (0.5%) at 1 year, 66 (1.9%) at 5 years, 97 (2.8%) at 10 years and 112 (3.2%) at 17 years. This risk was higher after TO-MUS than after RP-MUS operations (OR 3.6, 95% CI 2.5-5.2, p <0.001). The cumulative number of any long-term re-procedure was 43 (1.2%) at year 1, 105 (3.0%) at year 5, 144 (4.1%) at year 10 and 163 (4.6%) at year 17. Conclusions Re-procedures occur up to 17 years after primary MUS insertion, but their incidence is low after the first few postoperative years. Re-procedures for recurrent SUI are more common after TO-MUS than RP-MUS.Peer reviewe

Pregnancy and delivery after mid-urethral sling operation

There is no consensus regarding pregnancy after mid-urethral sling (MUS) operation, and some clinicians recommend postponing the MUS operation if a woman considers further pregnancies or routinely suggest cesarean section as the delivery method after MUS operations. Our primary aim was to assess the risk for stress urinary incontinence (SUI) re-procedure after delivery in women with a MUS operation prior to pregnancy. We also analyzed SUI re-visits and MUS-related complications during pregnancy and postpartum.Peer reviewe

Quality of life and sexual function after TVT surgery versus Bulkamid injection for primary stress urinary incontinence : 1 year results from a randomized clinical trial

Introduction and hypothesis To assess changes in quality of life (QoL) and sexual function outcomes at 1 year after tension-free vaginal tape (TVT) versus polyacrylamide hydrogel injection (PAHG). Methods In a randomized trial comparing TVT (n = 111) and PAHG (n = 113) treatments of stress urinary incontinence (SUI), we compared urinary incontinence and health-related QoL using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and 1 year. Results UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort. At 1 year, TVT patients experienced less urinary symptom-related distress compared to PAHG (p <0.001). Sexual function improved in both groups (p <0.001 for TVT and p = 0.01 for PAHG) with higher scores for the physical section subscale (p <0.001) for TVT. Health-related QoL (RAND-36) improved from baseline in both groups in physical and social functioning (p <0.001) with better outcome in the TVT group for physical functioning (p <0.001). Increase in pain from baseline (p = 0.02) was detected for TVT, but not for PAHG. However, there was no difference between the groups (p = 0.78). Conclusions In primary SUI, TVT and PAHG treatments both improved QoL and sexual function at 1 year. However, incontinence and health-related QoL scores were better in the TVT group. More pain compared to the baseline was reported after TVT, although there was no difference between groups. Clinical significance needs to be evaluated in long-term follow-up.Peer reviewe

Transumbilical versus lateral transabdominal removal of benign adnexal masses in laparoscopic surgery-A randomized trial

Objective: In laparoscopic adnexal surgery the conventional method of removing a mass from the abdominal cavity in Finland is through a 10-mm-wide lateral abdominal port. The larger the lateral trocar, the greater the risk of pain, complications and delayed recovery. Here, we assumed that adnexal mass removal through a 10-mm umbilical port together with 5-mm side trocars would decrease the postoperative need of analgesics when compared with removal through a 10-mm lateral abdominal port. Study design: Women scheduled for laparoscopic surgery of a benign adnexal mass were invited to participate. The participants were randomized into two groups: removal via the transumbilical (TO) (n = 21) or lateral transabdominal (TA) (n= 21) route. General anesthesia and use of local anesthetics were standardized. The amount of postoperative opioid (oxycodone) and visual analog scale (VAS) scores for pain were the primary outcome measures. Secondary outcome measures were nausea/vomiting (VAS evaluation), time to discharge, peri- and postoperative complications, surgeons' opinions of the alternative methods and patients' satisfaction, evaluated via a questionnaire sent six months postoperatively. Results: There were no significant differences in the use of opioids or median pain-VAS scores between the groups during the first 24 h postoperatively. However, in the TU group the amount of women with very low pain-VAS scores (0-1) during the whole 12-h follow-up time was significantly greater than in the TA group (4 vs. 0 women p=0.04). The amounts of nausea and vomiting, and median times to discharge were similar in both groups. There were no major complications. Conclusions: Both transumbilical and transabdominal routes of abdominal mass removal during laparoscopy were feasible and safe. However, the transumbilical route resulted in more women with very low pain-VAS scores. (C) 2017 Elsevier B.V. All rights reserved.Peer reviewe

Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence : 3-Year Followup from a Randomized Clinical Trial

PURPOSE: We sought to determine whether polyacrylamide hydrogel (PAHG) is noninferior to tension-free vaginal tape (TVT) in the treatment of women with primary stress urinary incontinence (SUI). MATERIALS AND METHODS: In this noninferiority trial, 223 women eligible for operative SUI treatment were randomized for TVT (110) or PAHG (113). Primary outcome was patient satisfaction and the noninferiority margin for the difference was 20%. Secondary outcomes were effectiveness and complications. RESULTS: At 3 years, 188 (84.3%) women attended the followup. The satisfaction score (visual analogue scale 0-100) median was 98.5 (IQR 90-100) in the TVT group and 90.0 (IQR 70-100) in the PAHG group, whereas a score ≥80 was reached in 87 (94.6%) and 65 (67.7%), respectively (difference 26.9%, 95% CI 16.7% to 36.8%). Thus, PAHG did not meet the noninferiority criteria set in our study. The cough stress test was negative in 88 (95.7%) of TVT patients vs 75 (78.1%) of PAHG patients (difference 17.5%, 95% CI 8.6% to 26.9%). Any peri- or postoperative complication before crossover between the groups was detected in 40 (43.5%) women in the TVT group and 23 (24.0%) women in the PAHG group (difference 19.5%, 95% CI 6.8% to 31.4%). CONCLUSIONS: In midterm followup, PAHG did not reach in patient satisfaction the noninferiority set in our study. Furthermore, mid urethral TVT slings show better subjective and objective cure rates than PAHG. However, complications were more often associated with TVT. Since the majority of PAHG treated women were also cured or improved, primary SUI women can be offered PAHG as a safe and durable alternative treatment.Peer reviewe

Components separation technique is feasible for assisting delayed primary fascial closure of open abdomen

Background and aims: The goal after open abdomen treatment is to reach primary fascial closure. Modern negative pressure wound therapy systems are sometimes inefficient for this purpose. This retrospective chart analysis describes the use of the components separation' method in facilitating primary fascial closure after open abdomen. Material and methods: A total of 16 consecutive critically ill surgical patients treated with components separation during open abdomen management were analyzed. No patients were excluded. Results: Primary fascial closure was achieved in 75% (12/16). Components separation was performed during ongoing open abdomen treatment in 7 patients and at the time of delayed primary fascial closure in 9 patients. Of the former, 3/7 (43%) patients reached primary fascial closure, whereas all 9 patients in the latter group had successful fascial closure without major complications (p=0.019). Conclusion: Components separation is a useful method in contributing to successful primary fascial closure in patients treated for open abdomen. Best results were obtained when components separation was performed simultaneously with primary fascial closure at the end of the open abdomen treatment.Peer reviewe

a pilot study, 2013

Introduction After recognition of European outbreaks of Clostridium difficile infections (CDIs) associated with the emergence of PCR ribotype 027/NAP1 in 2005, CDI surveillance at country level was encouraged by the European Centre for Disease Prevention and Control (ECDC) [1]. In 2008, an ECDC-supported European CDI survey (ECDIS) identified large intercountry variations in incidence rates and distribution of prevalent PCR ribotypes, with the outbreak-related PCR ribotype 027 being detected in 5% (range: 0–26) of the characterised isolates [2]. The surveillance period was limited to one month and the representation of European hospitals was incomplete; however, this has been the only European (comprising European Union (EU)/European Economic Area (EEA) and EU candidate countries) CDI surveillance study. The authors highlighted the need for national and European surveillance to control CDI. Yet, European countries were found to have limited capacity for diagnostic testing, particularly in terms of standard use of optimal methods and absence of surveillance protocols and a fully validated, standardised and exchangeable typing system for surveillance and/or outbreak investigation. As of 2011, 14 European countries had implemented national CDI surveillance, with various methodologies [3]. National surveillance systems have since reported a decrease in CDI incidence rate and/or prevalence of PCR ribotype 027 in some European countries [4-8]. However, CDI generally remains poorly controlled in Europe [9], and PCR ribotype 027 continues to spread in eastern Europe [10-12] and globally [13]. In 2010, ECDC launched a new project, the European C. difficile Infection Surveillance Network (ECDIS-Net), to enhance surveillance of CDI and laboratory capacity to test for CDI in Europe. The goal of ECDIS- Net was to establish a standardised CDI surveillance protocol suitable for application all over Europe in order to: (i) estimate the incidence rate and total infection rate of CDI (including recurrent CDI cases) in European acute care hospitals; (ii) provide participating hospitals with a standardised tool to measure and compare their own incidence rates with those observed in other participating hospitals; (iii) assess adverse outcomes of CDI such as complications and death; and (iv) describe the epidemiology of CDI concerning antibiotic susceptibility, PCR ribotypes, presence of tcdA, tcdB and binary toxins and detect new emerging types at local, national and European level. The primary objectives of the present study were to: (i) test the pilot protocol for the surveillance of CDI in European acute care hospitals developed by ECDIS-Net (methodology, variables and indicators); (ii) assess the feasibility and workload of collecting the required hospital data, case- based epidemiological and microbiological data; and (iii) evaluate the quality of data collected, whether in the presence or absence of existing national CDI surveillance activities. A secondary aim was to assess the relationship between patient and microbiological characteristics and in-hospital outcome of CDI to confirm the added value of collecting detailed epidemiological and microbiological data on CDI at European level

Standardised surveillance of Clostridium Difficile Infection in European acute care hospitals: A pilot study, 2013

Clostridium difficile infection (CDI) remains poorly controlled in many European countries, of which several have not yet implemented national CDI surveillance. In 2013, experts from the European CDI Surveillance Network project and from the European Centre for Disease Prevention and Control developed a protocol with three options of CDI surveillance for acute care hospitals: a ‘minimal’ option (aggregated hospital data), a ‘light’ option (including patient data for CDI cases) and an ‘enhanced’ option (including microbiological data on the first 10 CDI episodes per hospital). A total of 37 hospitals in 14 European countries tested these options for a three-month period (between 13 May and 1 November 2013). All 37 hospitals successfully completed the minimal surveillance option (for 1,152 patients). Clinical data were submitted for 94% (1,078/1,152) of the patients in the light option; information on CDI origin and outcome was complete for 94% (1,016/1,078) and 98% (294/300) of the patients in the light and enhanced options, respectively. The workload of the options was 1.1, 2.0 and 3.0 person-days per 10,000 hospital discharges, respectively. Enhanced surveillance was tested and was successful in 32 of the hospitals, showing that C. difficile PCR ribotype 027 was predominant (30% (79/267)). This study showed that standardised multicountry surveillance, with the option of integrating clinical and molecular data, is a feasible strategy for monitoring CDI in Europe