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Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Background Secondary peritonitis is a severe condition with a 20–32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two methods potential benefits and disadvantages. Methods This study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to at least two of the four abdominal quadrants originating from the small intestine, colon, or rectum. Randomisation will be web-based to either primary closure with ROD or VAC in blocks of 2, 4, and 6. The primary endpoint is peritonitis-related complications within 30 or 90 days and one year after index operation. Secondary outcomes are comprehensive complication index (CCI) and mortality after 30 or 90 days and one year; quality of life assessment by (SF-36) after three and 12 months, the development of incisional hernia after 12 months assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate. Discussion There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis. The present study has the potential to answer this important clinical question. Trial Registration The study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022.

Background Dislocation following total hip arthroplasty has to date not been resolved satisfactorily. Previous work has shown that using a less-invasive adaption of Bauer’s lateral transgluteal approach with capsular repair significantly reduces dislocation rates in primary total hip arthroplasty. The aim of this retrospective cohort study was to assess whether this approach also helps to reduce the dislocation rate in revision total hip arthroplasty. Methods We analyzed revision total hip arthroplasty cases performed between 10/2005 and 12/2013 in our department, classifying capsular repair cases as study group and capsular resection cases as control group. The WOMAC score, the dislocations and the revisions were observed. Results A total of 259 cases were included, 100 in the study group and 159 in the control group. In the 12-month follow-up, dislocation rates were significantly lower in the study group (3%, n  = 3) compared to the control group (21.4%, n  = 34; p  = 0.001). Overall follow-up periods were 49 and 79 months, revision frequencies were 10 and 29%, pain improvements were 5.5 compared to 4.4 and the WOMAC global scores averaged 2.0 ± 2.1 and 2.9 ± 2.6 for the study group and the control group, respectively. Conclusion The modified, less-invasive, lateral transgluteal approach with capsular repair was accompanied by an 86% reduction in dislocation rates when compared to the conventional technique with capsular resection via the anterolateral Watson-Jones-approach. Capsular repair is possible in about 60% of the revision total hip arthroplasty cases, may be considered as beneficial to avoid dislocation and can therefore be recommended.

Revision knee arthroplasty is assumed to be even more painful than primary knee arthroplasty and predominantly performed in chronic pain patients, which challenges postoperative pain treatment. We hypothesized that the adductor canal block, effective for pain relief after primary total knee arthroplasty, may reduce pain during knee flexion (primary endpoint: at 4 h) compared with placebo after revision total knee arthroplasty. Secondary endpoints were pain at rest, morphine consumption and morphine-related side effects. We included patients scheduled for revision knee arthroplasty in general anesthesia into this blinded, placebo-controlled, randomized trial. Patients were allocated to an adductor canal block via a catheter with either ropivacaine or placebo; bolus of 0.75% ropivacaine/saline, followed by infusion of 0.2% ropivacaine/saline. Clinicaltrials.gov ID: NCT01191593. We enrolled 36 patients, of which 30 were analyzed. Mean pain scores during knee flexion at 4 h (primary endpoint) were: 52 ± 22 versus 71 ± 25 mm (mean difference 19, 95% CI: 1 to 37, P = 0.04), ropivacaine and placebo group respectively. When calculated as area under the curve (1-8 h/7 h) pain scores were 55 ± 21 versus 69 ± 21 mm during knee flexion (P = 0.11) and 39 ± 18 versus 45 ± 23 mm at rest (P = 0.43), ropivacaine and placebo group respectively. Groups were similar regarding morphine consumption and morphine-related side effects (P > 0.05). The only statistically significant difference found between groups was in the primary endpoint: pain during knee flexion at 4 h. However, due to a larger than anticipated dropout rate and heterogeneous study population, the study was underpowered. Clinicaltrials.gov NCT01191593.

Total joint replacements for end-stage osteoarthritis of the hip and knee are cost-effective and demonstrate significant clinical improvement. However, robust population based lifetime-risk data for implant revision are not available to aid patient decision making, which is a particular problem in young patient groups deciding on best-timing for surgery. We did implant survival analysis on all patients within the Clinical Practice Research Datalink who had undergone total hip replacement or total knee replacement. These data were adjusted for all-cause mortality with data from the Office for National Statistics and used to generate lifetime risks of revision surgery based on increasing age at the time of primary surgery. We identified 63 158 patients who had undergone total hip replacement and 54 276 who had total knee replacement between Jan 1, 1991, and Aug 10, 2011, and followed up these patients to a maximum of 20 years. For total hip replacement, 10-year implant survival rate was 95·6% (95% CI 95·3–95·9) and 20-year rate was 85·0% (83·2–86·6). For total knee replacement, 10-year implant survival rate was 96·1% (95·8–96·4), and 20-year implant survival rate was 89·7% (87·5–91·5). The lifetime risk of requiring revision surgery in patients who had total hip replacement or total knee replacement over the age of 70 years was about 5% with no difference between sexes. For those who had surgery younger than 70 years, however, the lifetime risk of revision increased for younger patients, up to 35% (95% CI 30·9–39·1) for men in their early 50s, with large differences seen between male and female patients (15% lower for women in same age group). The median time to revision for patients who had surgery younger than age 60 was 4·4 years. Our study used novel methodology to investigate and offer new insight into the importance of young age and risk of revision after total hip or knee replacement. Our evidence challenges the increasing trend for more total hip replacements and total knee replacements to be done in the younger patient group, and these data should be offered to patients as part of the shared decision making process. Oxford Musculoskeletal Biomedical Research Unit, National Institute for Health Research.

Adhesions are the most common driver of long-term morbidity after abdominal surgery. Although laparoscopy can reduce adhesion formation, the effect of minimally invasive surgery on long-term adhesion-related morbidity remains unknown. We aimed to assess the impact of laparoscopy on adhesion-related readmissions in a population-based cohort. We did a retrospective cohort study of patients of any age who had abdominal or pelvic surgery done using laparoscopic or open approaches between June 1, 2009, and June 30, 2011, using validated population data from the Scottish National Health Service. All patients who had surgery were followed up until Dec 31, 2017. The primary outcome measure was the incidence of hospital readmissions directly related to adhesions in the laparoscopic and open surgery cohorts at 5 years. Readmissions were categorised as directly related to adhesions, possibly related to adhesions, and readmissions for an operation that was potentially complicated by adhesions. We did subgroup analyses of readmissions by anatomical site of surgery and used Kaplan-Meier analyses to assess differences in survival across subgroups. We used multivariable Cox-regression analysis to determine whether surgical approach was an independent and significant risk factor for adhesion-related readmissions. Between June 1, 2009, and June 30, 2011, 72 270 patients had an index abdominal or pelvic surgery, of whom 21 519 (29·8%) had laparoscopic index surgery and 50 751 (70·2%) had open surgery. Of the 72 270 patients who had surgery, 2527 patients (3·5%) were readmitted within 5 years of surgery for disorders directly related to adhesions, 12 687 (17·6%) for disorders possibly related to adhesions, and 9436 (13·1%) for operations potentially complicated by adhesions. Of the 21 519 patients who had laparoscopic surgery, 359 (1·7% [95% CI 1·5–1·9]) were readmitted for disorders directly related to adhesions compared with 2168 (4·3% [4·1–4·5]) of 50 751 patients in the open surgery cohort (p<0·0001). 3443 (16·0% [15·6–16·4]) of 21 519 patients in the laparoscopic surgery cohort were readmitted for disorders possibly related to adhesions compared with 9244 (18·2% [17·8–18·6]) of 50 751 patients in the open surgery cohort (p<0·005). In multivariate analyses, laparoscopy reduced the risk of directly related readmissions by 32% (hazard ratio [HR] 0·68, 95% CI 0·60–0·77), and of possibly related readmissions by 11% (HR 0·89, 0·85–0·94) compared with open surgery. Procedure type, malignancy, sex, and age were also independently associated with risk of adhesion-related readmissions. Laparoscopic surgery reduces the incidence of adhesion-related readmissions. However, the overall burden of readmissions associated with adhesions remains high. With further increases in the use of laparoscopic surgery expected in the future, the effect at the population level might become larger. Further steps remain necessary to reduce the incidence of adhesion-related postsurgical complications. Dutch Adhesion Group and Nordic Pharma.

BackgroundWhether one anastomosis gastric bypass (OAGB) or Roux-en-Y gastric bypass (RYGB) is a better revisional bariatric surgery (RBS) after sleeve gastrectomy (SG) is still under debate. The aim is to compare short-term outcomes of RYGB and OAGB as a RBS after SG, pertaining to their effects on weight loss, resolution of comorbidities, and complications.MethodsWe performed a single-center analysis of 55 patients (n = 34 OAGB, n = 21 RYGB). Indications for revisional surgery included weight regain/loss failure (67%) and intractable gastroesophageal reflux disease (33%). Data were collected up to 1-year follow-up (FU) and included time of revisional surgery, operation time, weight, body mass index, excess weight loss, and total weight loss (TWL), both in percent, complications and resolution of comorbidities.ResultsOperation time was 79 ± 36 (OAGB-MGB) and 98 ± 24 min (RYGB) (p = 0.03). In the first 30 postoperative days, three patients in the RYGB group, and no patient in the OAGB group, had postoperative complications. FU was 100%. Minor complication rates at 12 months were 33.3% (RYGB) and 35.3% (OAGB). At 12 months, mean % TWL was 10.3 ± 7.6% (RYGB) and 15.8 ± 7.8% (OAGB) (p = 0.0132).ConclusionsOAGB after failed SG was found to be a quicker procedure with less perioperative complications. At 1-year FU, no significant differences were seen between RYGB and OAGB regarding readmission and minor complications. Still long-term FU including the risk of malnutrition is needed to have a complete evaluation of OAGB as a RBS for the future.

The two-stage revision strategy has been claimed as being the \"gold standard\" for treating prosthetic joint infection. The one-stage revision strategy remains an attractive alternative option; however, its effectiveness in comparison to the two-stage strategy remains uncertain. To compare the effectiveness of one- and two-stage revision strategies in treating prosthetic hip infection, using re-infection as an outcome. Systematic review and meta-analysis. MEDLINE, EMBASE, Web of Science, Cochrane Library, manual search of bibliographies to March 2015, and email contact with investigators. Cohort studies (prospective or retrospective) conducted in generally unselected patients with prosthetic hip infection treated exclusively by one- or two-stage revision and with re-infection outcomes reported within two years of revision. No clinical trials were identified. Data were extracted by two independent investigators and a consensus was reached with involvement of a third. Rates of re-infection from 38 one-stage studies (2,536 participants) and 60 two-stage studies (3,288 participants) were aggregated using random-effect models after arcsine transformation, and were grouped by study and population level characteristics. In one-stage studies, the rate (95% confidence intervals) of re-infection was 8.2% (6.0-10.8). The corresponding re-infection rate after two-stage revision was 7.9% (6.2-9.7). Re-infection rates remained generally similar when grouped by several study and population level characteristics. There was no strong evidence of publication bias among contributing studies. Evidence from aggregate published data suggest similar re-infection rates after one- or two-stage revision among unselected patients. More detailed analyses under a broader range of circumstances and exploration of other sources of heterogeneity will require collaborative pooling of individual participant data. PROSPERO 2015: CRD42015016559.

BackgroundSleeve gastrectomy (SG) frequently requires conversion to Roux-en-Y gastric bypass (RYGB) due to gastroesophageal reflux disease (GERD) or weight recurrence. Current evidence evaluating the safety of conversion from SG to RYGB and its indications is limited to single centers.MethodsThe objective was to determine the rate of serious complications and mortality of conversion of SG to RYGB (SG-RYGB) compared to primary RYGB (P-RYGB). This was a retrospective analysis of the MBSAQIP database which includes 30-day outcomes. Individuals undergoing P-RYGB or SG-RYGB were included. Multivariable logistic regression was performed to determine if revisional surgery was an independent predictor of serious complications or mortality.ResultsIn 2020 and 2021, 84,543 (86.3%) patients underwent P-RYGB and 13,432 (13.7%) underwent SG-RYGB. SG-RYGB cohort had lower body mass index, lower rates of diabetes and hypertension, and higher rates of GERD. GERD was the most common indication for revision (55.3%) followed by weight regain (24.4%) and inadequate weight loss (12.7%). SG-RYGB had longer operative times (145 vs. 125 min, p < 0.001) and a higher rate of serious complications (7.2 vs. 5.0%, p < 0.001). This included higher rates of anastomotic leak (0.5 vs. 0.4%, p = 0.002), bleeding (2.0 vs. 1.6%, p < 0.001), and reoperation (3.0 vs. 1.9%, p < 0.001) but not death (0.1 vs. 0.1%, p = 0.385). On multivariable analysis, SG-RYGB was independently predictive of serious complications (OR 1.21, 95%CI 1.12 to 1.32, p < 0.001) but not mortality (p = 0.316).ConclusionsWhile SG-RYGB is safe with a low complication rate, SG-RYGB was associated with a higher rate of serious complications compared to P-RYGB.

Background It has been observed that 5–8% of primary bariatric procedures result in inadequate treatment response, necessitating the need for revisional surgery. In this systematic review and meta-analysis, we aim to compare the effectiveness of single anastomosis duodeno-ileal bypass (SADI) and one anastomosis gastric bypass (OAGB) in addressing weight recurrence following sleeve gastrectomy. Methods We systematically searched PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials databases. Studies were considered eligible if they compared SADI with OAGB as revisional surgeries following sleeve gastrectomy. Results Our search strategy yielded four articles with a total of 309 patients. Regarding weight loss at 1 year of follow-up, SADI was favorable based on excess weight loss percentage (EWL%) and total weight loss percentage (TWL%). At 2 years of follow-up, EWL% did not show a statistically significant difference between the two operations although TWL% was higher in SADI group. Regarding postoperative bile reflux, the OAGB group had a significantly higher incidence of biliary reflux (OR 0.15; 95% CI 0.04 to 0.53; P  = 0.003). Patients enrolled in SADI did not develop anastomotic ulcers according to the four studies included in the analysis. In contrast, seven patients in the OAGB group did develop anastomotic ulcers, but the difference was not statistically significant (OR 0.23; 95% CI 0.05 to 1.10; P  = 0.07). Conclusion ADI is a feasible procedure with a favorable outcome compared to OAGB as a revisional surgery following sleeve gastrectomy regarding weight loss at 1 year with a lower incidence of postoperative biliary reflux.