Efficacy of a decision aid in breast cancer patients considering immediate reconstruction: results of a randomized controlled trial.

PURPOSE: Breast cancer patients face complex decisions about immediate breast reconstruction (BR) after mastectomy. We evaluated the efficacy of an online decision aid in improving the decision-making process, decision quality and health outcomes in breast cancer patients considering immediate BR. METHODS: In a multicenter randomized controlled trial, patients were allocated to either the intervention group receiving care-as-usual (CAU) with access to an online decision aid, or the control group receiving CAU with an information leaflet. The primary outcome was decisional conflict. Secondary outcomes assessed the process of decision making (e.g. preparation for decision making, satisfaction with information), decision quality (decision regret, knowledge) and health outcomes (e.g. satisfaction with BR outcomes, body image). Patients completed questionnaires at baseline (T0), 1 week after consultation with a plastic surgeon (T1), 3 months (T2), and 12 months post-surgery (T3). RESULTS: We included 250 patients. Decisional conflict decreased over time in both groups, with no between group differences. Intervention participants felt better prepared for decision making than controls (P = .002). At T2, 87% of intervention participants were (very) satisfied with the information about BR, compared to 73% of control participants (P = .011). No significant between group differences were observed in any other outcome. CONCLUSION: Our online decision aid was as effective in reducing decisional conflict as an information leaflet about immediate BR after mastectomy. However, the decision aid substantially improved the decision-making process by better preparing breast cancer patients for decisions about immediate BR.

Cost-effectiveness of Breast Cancer Screening With Magnetic Resonance Imaging for Women at Familial Risk.

Importance: For women with a 20% or more familial risk of breast cancer without a known BRCA1/2 (BRCA1, OMIM 113705; and BRCA2, OMIM 114480) or TP53 (OMIM 151623) variant, screening guidelines vary substantially, and cost-effectiveness analyses are scarce. Objective: To assess the cost-effectiveness of magnetic resonance imaging (MRI) screening strategies for women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant. Design, Setting, and Participants: In this economic evaluation, conducted from February 1, 2019, to May 25, 2020, microsimulation modeling was used to estimate costs and effectiveness on a lifetime horizon from age 25 years until death of MRI screening among a cohort of 10 million Dutch women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant. A Dutch screening setting was modeled. Most data were obtained from the randomized Familial MRI Screening (FaMRIsc) trial, which included Dutch women aged 30 to 55 years. A health care payer perspective was applied. Interventions: Several screening protocols with varying ages and intervals including those of the randomized FaMRIsc trial, consisting of the mammography (Mx) protocol (annual mammography and clinical breast examination) and the MRI protocol (annual MRI and clinical breast examination plus biennial mammography). Main Outcomes and Measures: Costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated and discounted by 3%. A threshold of €22 000 (US $24 795.87) per QALY was applied. Results: This economic evaluation modeling study estimated that, on a lifetime horizon per 1000 women with the Mx protocol of the FaMRIsc trial, 346 breast cancers would be detected, and 49 women were estimated to die from breast cancer, resulting in 22 885 QALYs and total costs of €7 084 767 (US $7 985 134.61). The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65). Magnetic resonance imaging performed only every 18 months between the ages of 35 and 60 years followed by the national screening program was considered optimal, with an ICER of €21 380 (US $24 097.08) compared with the previous nondominated strategy in the ranking, when applying the National Institute for Health and Care Excellence threshold. Annual screening alternating MRI and mammography between the ages of 35 and 60 years, followed by the national screening program, gave similar outcomes. Higher thresholds would favor annual MRI screening. The ICER was most sensitive to the unit cost of MRI and the utility value for ductal carcinoma in situ and localized breast cancer. Conclusions and Relevance: This study suggests that MRI screening every 18 months between the ages of 35 and 60 years for women with a family history of breast cancer is cost-effective within the National Institute for Health and Care Excellence threshold for all densities. Higher thresholds would favor annual MRI screening. These outcomes support a change of current screening guidelines for this specific risk group and support MRI screening.

MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): a multicentre, randomised, controlled trial.

BACKGROUND: Approximately 15% of all breast cancers occur in women with a family history of breast cancer, but for whom no causative hereditary gene mutation has been found. Screening guidelines for women with familial risk of breast cancer differ between countries. We did a randomised controlled trial (FaMRIsc) to compare MRI screening with mammography in women with familial risk. METHODS: In this multicentre, randomised, controlled trial done in 12 hospitals in the Netherlands, women were eligible to participate if they were aged 30-55 years and had a cumulative lifetime breast cancer risk of at least 20% because of a familial predisposition, but were BRCA1, BRCA2, and TP53 wild-type. Participants who were breast-feeding, pregnant, had a previous breast cancer screen, or had a previous a diagnosis of ductal carcinoma in situ were eligible, but those with a previously diagnosed invasive carcinoma were excluded. Participants were randomly allocated (1:1) to receive either annual MRI and clinical breast examination plus biennial mammography (MRI group) or annual mammography and clinical breast examination (mammography group). Randomisation was done via a web-based system and stratified by centre. Women who did not provide consent for randomisation could give consent for registration if they followed either the mammography group protocol or the MRI group protocol in a joint decision with their physician. Results from the registration group were only used in the analyses stratified by breast density. Primary outcomes were number, size, and nodal status of detected breast cancers. Analyses were done by intention to treat. This trial is registered with the Netherlands Trial Register, number NL2661. FINDINGS: Between Jan 1, 2011, and Dec 31, 2017, 1355 women provided consent for randomisation and 231 for registration. 675 of 1355 women were randomly allocated to the MRI group and 680 to the mammography group. 218 of 231 women opting to be in a registration group were in the mammography registration group and 13 were in the MRI registration group. The mean number of screening rounds per woman was 4·3 (SD 1·76). More breast cancers were detected in the MRI group than in the mammography group (40 vs 15; p=0·0017). Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023). Tumour stages of the cancers detected at incident rounds were significantly earlier in the MRI group (12 [48%] of 25 in the MRI group vs one [7%] of 15 in the mammography group were stage T1a and T1b cancers; one (4%) of 25 in the MRI group and two (13%) of 15 in the mammography group were stage T2 or higher; p=0·035) and node-positive tumours were less frequent (two [11%] of 18 in the MRI group vs five [63%] of eight in the mammography group; p=0·014). All seven tumours stage T2 or higher were in the two highest breast density categories (breast imaging reporting and data system categories C and D; p=0·0077) One patient died from breast cancer during follow-up (mammography registration group). INTERPRETATION: MRI screening detected cancers at an earlier stage than mammography. The lower number of late-stage cancers identified in incident rounds might reduce the use of adjuvant chemotherapy and decrease breast cancer-related mortality. However, the advantages of the MRI screening approach might be at the cost of more false-positive results, especially at high breast density. FUNDING: Dutch Government ZonMw, Dutch Cancer Society, A Sister's Hope, Pink Ribbon, Stichting Coolsingel, J&T Rijke Stichting.

Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial.

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 [<1%] in the suture group vs five [3%] in the mesh group), haematoma (two [1%] vs three [2%]), and wound infection (one [<1%] vs three [2%]). There were no anaesthetic complications or postoperative deaths. INTERPRETATION: This is the first study showing high level evidence for mesh repair in patients with small hernias of diameter 1-4 cm. Hence we suggest mesh repair should be used for operations on all patients with an umbilical hernia of this size. FUNDING: Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.

Randomized clinical trial of total extraperitoneal inguinal hernioplasty vs Lichtenstein repair: a long-term follow-up study.

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.

Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial.

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 (euro3.096 vs. euro3.198) 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.

Endovascular treatment of atherosclerosis at the aortoiliac bifurcation with kissing stents or distal aortic stents: a temporary solution or durable improvement?

To evaluate medium-term technical and clinical success after endovascular treatment of stenosis or occlusion at the aortoiliac bifurcation with a distal aortic stent or kissing stents. Between 1995 and 2004, 25 patients were included in the study. Nine patients were treated with an aortic stent, and 16 patients were treated with kissing stents. Clinical and radiologic findings were retrospectively reviewed, and statistical analysis was performed. In all cases, the procedure was technically successful. Hemodynamic success was observed in 22 patients (88%), and clinical success was observed in 23 patients (92%). After a median follow-up of 21 months, 8 patients developed a restenosis (n = 6) or occlusion (n = 2). Two patients with restenosis were treated successfully with aortic bifurcation grafts, and 4 patients underwent endovascular reintervention. No risk factors for restenosis were identified. Primary patency was 87% after 1 year and 65% after 2 years. Secondary patency was 90% after 1 year and 72% after 2 years. At the last outpatient control, 22 patients (88%) were free of symptoms. Endovascular treatment of symptomatic aortoiliac atherosclerosis at the aortoiliac bifurcation by means of a distal aortic stent or kissing stents can be used successfully with durable improvement in the majority of patients. We recommend it as the initial treatment modality.

Incisional hernia after repair of wound dehiscence: incidence and risk factors.

The true incidence of incisional hernia after wound dehiscence repair remains unclear because thorough long-term follow-up studies are not available. Medical records of all patients who had undergone wound dehiscence repair between January 1985 and January 1999 at the Erasmus University Medical Center Rotterdam were reviewed. Long-term follow-up was performed by physical examination of all patients in February 2001. One hundred sixty-eight patients underwent wound dehiscence repair. Of those, 42 patients (25%) died within 60 days after surgery. During a median follow-up of 37 months (range, 3-146 months), 55 of the remaining 126 patients developed an incisional hernia. The cumulative incidence of incisional hernia was 69 per cent at 10 years. Significant independent risk factors were aneurysm of the abdominal aorta (10-year cumulative incidence of 84%, P = 0.02) and severe dehiscence with evisceration (10-year cumulative incidence of 78%, P = 0.01). Wound dehiscence repair by interrupted sutures had no better outcome than repair by continuous sutures. Suture material did not influence incidence of incisional hernia. Incisional hernia develops in the majority of patients after wound dehiscence repair, regardless of suture material or technique. Aneurysm of the abdominal aorta and severe dehiscence with evisceration predispose to incisional hernia.

Prevention of adhesion to prosthetic mesh: comparison of different barriers using an incisional hernia model.

OBJECTIVE: To assess whether use of antiadhesive liquids or coatings could prevent adhesion formation to prosthetic mesh. SUMMARY BACKGROUND DATA: Incisional hernia repair frequently involves the use of prosthetic mesh. However, concern exists about development of adhesions between viscera and the mesh, predisposing to intestinal obstruction or enterocutaneous fistulas. METHODS: In 91 rats, a defect in the muscular abdominal wall was created, and mesh was fixed intraperitoneally to cover the defect. Rats were divided in five groups: polypropylene mesh only (control group), addition of Sepracoat or Icodextrin solution to polypropylene mesh, Sepramesh (polypropylene mesh with Seprafilm coating), and Parietex composite mesh (polyester mesh with collagen coating). Seven and 30 days postoperatively, adhesions were assessed and wound healing was studied by microscopy. RESULTS: Intraperitoneal placement of polypropylene mesh was followed by bowel adhesions to the mesh in 50% of the cases. A mean of 74% of the mesh surface was covered by adhesions after 7 days, and 48% after 30 days. Administration of Sepracoat or Icodextrin solution had no influence on adhesion formation. Coated meshes (Sepramesh and Parietex composite mesh) had no bowel adhesions. Sepramesh was associated with a significant reduction of the mesh surface covered by adhesions after 7 and 30 days. Infection was more prevalent with Parietex composite mesh, with concurrent increased mesh surface covered by adhesions after 30 days (78%). CONCLUSIONS: Sepramesh significantly reduced mesh surface covered by adhesions and prevented bowel adhesion to the mesh. Parietex composite mesh prevented bowel adhesions as well but increased infection rates in the current model.