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Background Breast cancer (BC) patients who are treated with mastectomy are frequently offered immediate breast reconstruction. This study aimed to assess decisional conflict in patients considering immediate breast reconstruction, and to identify factors associated with clinically significant decisional conflict (CSDC). Methods Baseline data of a multicenter randomized controlled trial evaluating the impact of an online decision aid for BC patients considering immediate breast reconstruction after mastectomy were analyzed. Participants completed questionnaires assessing sociodemographic and clinical characteristics, decisional conflict and other patient-reported outcomes related to decision-making such as breast reconstruction preference, knowledge, information resources used, preferred involvement in decision-making, information coping style, and anxiety. Multivariable logistic regression analysis was performed to identify factors associated with CSDC (score > 37.5 on decisional conflict). Results Of the 250 participants, 68% experienced CSDC. Patients with a slight preference for breast reconstruction (odds ratio (OR) = 6.19, p, Highlights • A majority of patients considering immediate breast reconstruction experience decisional conflict. • Patients without a strong preference for breast reconstruction are more likely to experience decisional conflict. • Patients with more anxiety are more likely to experience decisional conflict.

Background: The large favorable stage shift, that MRI screening causes as compared with mammography has been published recently in Lancet Oncology as well as the disadvantage of more false-positive results with MRI. Here we want to present the first results of cost and effectiveness. Methods: In twelve Dutch hospitals, 1355 women aged 30-55 years with a cumulative lifetime risk (CLTR) of ≥20% without a BRCA1/2 mutation were randomized into two groups. From January 2011 until December 2017, women in the MRI-group received yearly MRI-screening, clinical breast examination (CBE), and mammography every other year; and in the Mx-group yearly mammography and CBE. We here present cost per group as well as per detected cancer in both groups, also by age group and breast density. Cost per life year gained can be presented in December. Results: After on average 4.3 screening rounds per woman, in the MRI-group (N=674) compared to the Mx-group (N=680) more breast cancers were detected (40 versus 15, p This study was supported by funds of: the Dutch Governement ZonMw grant no. 200320002, The Dutch Cancer Society (DDHK 2009-4491), A Sisters Hope, Pink Ribbon, Stichting Coolsingel, J&T Rijke Stichting. Table 1. Characteristics of participating women, detected breast cancers, and cost according to study armParticipantsMRI-arm n=674Mx-arm n=680p-valueMean age - yr ± SD44.7 ± 6.344.7 ± 6.3Premenopausal512 (76%)505 (74%)BI-RADS density categorya A(entirely fat) B (scattered densities) C (heterogeneously dense) D (extremely dense)88 (13%) 248 (37%) 237 (35%) 98 (15%)92 (14%) 229 (34%) 243 (36%) 102 (15%)Mean age at cancer detection49,6 ± 7.150,8 ± 4,60.88No cancer - no. (%) Invasive breast cancers - no. (%) DCIS - no. (%)634 (94%) 24 (4%) 16 (2%)666 (98%) 8 (1%) 7 (1%)0.0017Median size of invasive cancers9 mm (5-14)17 mm (13-22)0.01Node positive4/24 (17%)5/8 (63%)0.023Biopsy nr.14954< 0.0001Total screening cost in FaMRIsc€ 1,094,241€ 516,440Cost per detected cancer€ 32,340€ 42,384Cost per detected ca. BIRADS A-C€ 28,945€ 39,964aDetermined by radiologists, according to the fourth ACR BI-RADS edition Citation Format: Madeleine MA Tilanus-Linthorst, H Amarens Geuzinge, Inge-Marie M Obdeijn, Emiel JT Rutgers, Ritse M Mann, Sepideh Saadatmand, Diderick BW de Roy van Zuidewijn, Robert AEM Tollenaar, Marc BI Lobbes, Margreet GEM Ausems, Martijne van 't Riet, Maartje J Hooning, Jelle Wesseling, Ingeborg Mares-Engelberts, Ernest JT Luiten, Jan C Oosterwijk, Eveline AM Heijnsdijk, Harry J de Koning. Costs and effects in the first randomized trial comparing MRI breast cancer screening with mammography in women with a familial risk: FaMRIsc [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr GS4-07.

Background: Both mesh and suture repair are used for the treatment of umbilical hernias, but for smaller umbilical hernias (diameter 1–4 cm) there is little evidence whether mesh repair would be beneficial. In this study we aimed to investigate whether use of a mesh was better in reducing recurrence compared with suture repair for smaller umbilical hernias. Methods: We did a randomised, double-blind, controlled multicentre trial in 12 hospitals (nine in the Netherlands, two in Germany, and one in Italy). Eligible participants were adults aged at least 18 years with a primary umbilical hernia of diameter 1–4 cm, and were randomly assigned (1:1) intraoperatively to either suture repair or mesh repair. In the first 3 years of the inclusion period, blocked randomisation (of non-specified size) was achieved by an envelope randomisation system; after this time computer-generated randomisation was introduced. Patients, investigators, and analysts were masked to the allocated treatment, and participants were stratified by hernia size (1–2 cm and >2–4 cm). At study initiation, all surgeons were invited to training sessions to ensure they used the same standardised techniques for suture repair or mesh repair. Patients underwent physical examinations at 2 weeks, and 3, 12, and 24–30 months after the operation. The primary outcome was the rate of recurrences of the umbilical hernia after 24 months assessed in the modified intention-to-treat population by physical examination and, in case of any doubt, abdominal ultrasound. This trial is registered with ClinicalTrials.gov, number NCT00789230. Findings: Between June 21, 2006, and April 16, 2014, we randomly assigned 300 patients, 150 to mesh repair and 150 to suture repair. The median follow-up was 25·1 months (IQR 15·5–33·4). After a maximum follow-up of 30 months, there were fewer recurrences in the mesh group than in the suture group (six [4%] in 146 patients vs 17 [12%] in 138 patients; 2-year actuarial estimates of recurrence 3·6% [95% CI 1·4–9·4] vs 11·4% (6·8–18·9); p=0·01, hazard ratio 0·31, 95% CI 0·12–0·80, corresponding to a number needed to treat of 12·8). The most common postoperative complications were seroma (one [

© 2017 Elsevier Ltd Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63–1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06–3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [

HYPOTHESIS: Mesh repair is generally preferred for surgical correction of inguinal hernia, although the merits of endoscopic techniques over open surgery are still debated. Herein, minimally invasive total extraperitoneal inguinal hernioplasty (TEP) was compared with Lichtenstein repair to determine if one is associated with less postoperative pain, hypoesthesia, and hernia recurrence. DESIGN: Prospective multicenter randomized clinical trial. SETTING: Academic research. PATIENTS: Six hundred sixty patients were randomized to TEP or Lichtenstein repair. MAIN OUTCOME MEASURES: The primary outcome was postoperative pain. Secondary end points were hernia recurrence, operative complications, operating time, length of hospital stay, time to complete recovery, quality of life, chronic pain, and operative costs. RESULTS: At 5 years after surgery, TEP was associated with less chronic pain (P = .004). Impairment of inguinal sensibility was less frequently seen after TEP vs Lichtenstein repair (1% vs 22%, P < .001). Operative complications were more frequent after TEP vs Lichtenstein repair (6% vs 2%, P < .001), while no difference was noted in length of hospital stay. After TEP, patients had faster time to return to daily activities (P < .002) and less absence from work (P = .001). Although operative costs were higher for TEP, total costs were comparable for the 2 procedures, as were overall hernia recurrences at 5 years after surgery. However, among experienced surgeons, significantly lower hernia recurrence rates were seen after TEP (P < .001). CONCLUSIONS: In the short term, TEP was associated with more operative complications, longer operating time, and higher operative costs; however, total costs were comparable for the 2 procedures. Chronic pain and impairment of inguinal sensibility were more frequent after Lichtenstein repair. Although overall hernia recurrence rates were comparable for both procedures, hernia recurrence rates among experienced surgeons were significantly lower after TEP. Patient satisfaction was also significantly higher after TEP. Therefore, TEP should be recommended in experienced hands. Trial Registration clinicaltrials.gov Identifier: NCT00788554.

Background: This randomized controlled trial was designed to compare the most common technique for open mesh repair (Lichtenstein) with the currently preferred minimally invasive technique (total extra peritoneal, TEP) for the surgical correction of inguinal hernia. Methods: A total of 660 patients were randomized to Lichtenstein or TEP procedure. Primary outcomes were postoperative pain, length of hospital stay, period until complete recovery, and quality of life (QOL). Recurrences, operating time, complications, chronic pain, and costs were secondary endpoints. This study was registered at www.clinicaltrials.gov and carries the ID: NCT00788554. Results: About 336 patients were randomized to TEP, and 324 to Lichtenstein repair. TEP was associated with less postoperative pain until 6 weeks postoperatively (P = 0.01). Chronic pain was comparable (25% vs. 29%). Less impairment of inguinal sensibility was seen after TEP (7% vs. 30%, P = 0.01). Mean operating time for a unilateral hernia with TEP was longer (54 vs. 49 minutes, P = 0.03) but comparable for bilateral hernias. Incidence of adverse events during surgery was higher with TEP (5.8% vs. 1.6%, P < 0.004), but postoperative complications (33% vs. 33%), hospital stay and QOL were similar. After TEP, patients had a faster recovery of daily activities (ADL) and less absence from work (P = 0.01). After a mean follow-up of 49 months, recurrences (3.8% vs. 3.0%, P = 0.64) and total costs ((sic)3.096 vs. (sic)3.198) were similar. Conclusion: TEP procedure was associated with more adverse events during surgery but less postoperative pain, faster recovery of daily activities, quicker return to work, and less impairment of sensibility after 1 year. Recurrence rates and chronic pain were comparable. TEP is recommended in experienced hands.