scholarly journals Does Mesh Augmentation of the Hiatal Repair with Gore Bio-A® Improve Symptomatic Outcomes in Laparoscopic Fundoplication?

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Christodoulidou M ◽  
Kosai NR ◽  
Rajan R ◽  
Hassan S ◽  
Das S ◽  
...  

Introduction: Laparoscopic fundoplication is performed for the management of symptomatic hiatus hernias and gastro-oesophageal reflux disease (GORD) refractory to medical therapy. We adopted the use of Gore Bio-A® for selected laparoscopic hiatus hernia repairs in 2011 and with this case series aimed to establish whether mesh augmentation affects symptomatic outcomes. Methods: A retrospective review of prospectively collected data from all laparoscopic fundoplications performed by a single surgeon between October 2011 and January 2013 was performed. Patient specific data were entered into a proforma and analysed using Microsoft ExcelTM. Patient reported outcomes were assessed with a system specific quality of life questionnaire (GORD-HRQL) both pre and post-operatively. Results: Twenty-three patients underwent laparoscopic fundoplication during the study period. Gore Bio-A® re-enforcement of the hiatal repair was used in 14 patients and was the preferred option for those with pre-operative evidence of a large hiatus hernia. Whilst overall there was a statistically significant difference between pre and post-operative scores (21 vs 0, p=<0.0001, Mann-Whitney U test), there was no clear difference observed in pre-operative scores (22 vs 20, p=0.21, Mann-Whitney U test), postoperative scores (0 vs 0, p=0.92, Mann-Whitney U test) or symptom improvement (21 vs 20, p=0.24, MannWhitney U test) between the mesh and non-mesh groups. Conclusions: Augmentation of the hiatal repair with biosynthetic mesh is safe, feasible and may contribute to improved symptomatic outcomes in selected cases with a large hiatus hernia. We suggest a further assessment with a larger randomised sample and long term follow-up for definitive evaluation.

2021 ◽  
Vol 103-B (7) ◽  
pp. 1270-1276
Author(s):  
David N. Townshend ◽  
Andrew J. F. Bing ◽  
Timothy M. Clough ◽  
Ian T. Sharpe ◽  
Andy Goldberg ◽  
...  

Aims This is a multicentre, non-inventor, prospective observational study of 503 INFINITY fixed bearing total ankle arthroplasties (TAAs). We report our early experience, complications, and radiological and functional outcomes. Methods Patients were recruited from 11 specialist centres between June 2016 and November 2019. Demographic, radiological, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Questionnaire, and EuroQol five-dimension five-level score) were collected preoperatively, at six months, one year, and two years. The Canadian Orthopaedic Foot and Ankle Society (COFAS) grading system was used to stratify deformity. Early and late complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts, and/or subsidence. Results In all, 500 patients reached six-month follow-up, 420 reached one-year follow-up, and 188 reached two-year follow-up. The mean age was 67.8 years (23.9 to 88.5). A total of 38 patients (7.5%) presented with inflammatory arthritis. A total of 101 (20.0%) of implantations used patient-specific instrumentation; 167 patients (33.1%) underwent an additional procedure at the time of surgery. A total of seven patients died of unrelated causes, two withdrew, and one was lost to follow-up. The mean follow-up was 16.2 months (6 to 36). There was a significant improvement from baseline across all functional outcome scores at six months, one, and two years. There was no significant difference in outcomes with the use of patient-specific instrumentation, type of arthritis, or COFAS type. Five (1.0%) implants were revised. The overall complication rate was 8.8%. The non-revision reoperation rate was 1.4%. The 30-day readmission rate was 1.2% and the one-year mortality 0.74%. Conclusion The early experience and complications reported in this study support the current use of the INFINITY TAA as a safe and effective implant in the treatment of end-stage ankle arthritis. Cite this article: Bone Joint J 2021;103-B(7):1270–1276.


2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
V Lazzari ◽  
P Milito ◽  
R Scaramuzzo ◽  
E Asti ◽  
L Bonavina

Abstract Aim To compare quality of life in patients with large hiatus hernia undergoing laparoscopic Toupet fundoplication and magnetic sphincter augmentation. Background and Methods Laparoscopic Toupet fundoplication (LTF) and laparoscopic magnetic sphincter augmentation (MSA) have been compared in a previous retrospective study (Asti E et al, Medicine, 2016) in patients with small hiatal hernia (<3 cm). There is no universal consensus in the use of MSA in patients with large hiatus hernia. This is an observational, retrospective, comparative cohort study. Patients with <3 cm or >5 cm hiatus hernia measured by endoscopy and barium swallow study and those with previous esophago-gastric surgery were excluded. The primary outcome was quality of life based on the Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire. Secondary outcomes were proton pump inhibitors (PPI) use, incidence of dysphagia and gas-related symptoms, and hiatus hernia recurrence rate. Results Between March 2007 and June 2018, 150 patients with GERD met the inclusion criteria; 88 underwent a LTF and 62 a MSA procedure. Both groups had similar preoperative features. The mean follow-up was 64 months and all patients were followed for at least one year after surgery. There was no statistically significant difference between LTF and MSA in GERD-HRQL scores (p=0.178), PPI use (p=0.327), gas-related symptoms (p=0.162), dysphagia (p=0.254), and reoperation rate (p=0.167). Conclusion Both LTF and MSA have similar safety profile and disease-specific quality of life in patients with large hiatal hernia.


2021 ◽  
Vol 10 (7) ◽  
pp. 1439
Author(s):  
Vicente J. León-Muñoz ◽  
Andrea Parrinello ◽  
Silvio Manca ◽  
Gianluca Galloni ◽  
Mirian López-López ◽  
...  

There have been remarkable advances in knee replacement surgery over the last few decades. One of the concerns continues to be the accuracy in achieving the desired alignment. Patient-specific instrumentation (PSI) was developed to increase component placement accuracy, but the available evidence is not conclusive. Our study aimed to determine a PSI system’s three-dimensional accuracy on 3D virtual models obtained by post-operative computed tomography. We compared the angular placement values of 35 total knee arthroplasties (TKAs) operated within a year obtained with the planned ones, and we analyzed the possible relationships between alignment and patient-reported outcomes. The mean (SD) discrepancies measured by two experienced engineers to the planned values observed were 1.64° (1.3°) for the hip–knee–ankle angle, 1.45° (1.06°) for the supplementary angle of the femoral lateral distal angle, 1.44° (0.97°) for the proximal medial tibial angle, 2.28° (1.78°) for tibial slope, 0.64° (1.09°) for femoral sagittal flexion, and 1.42° (1.06°) for femoral rotation. Neither variables related to post-operative alignment nor the proportion of change between pre-and post-operative alignment influenced the patient-reported outcomes. The evaluated PSI system’s three-dimensional alignment analysis showed a statistically significant difference between the angular values planned and those obtained. However, we did not find a relevant effect size, and this slight discrepancy did not impact the clinical outcome.


Author(s):  
Misbah Noshela Ghazanfar ◽  
Ewa Anna Bartko ◽  
Nicolai Skovbjerg Arildsen ◽  
Lars Poulsen K ◽  
Bettina Jensen ◽  
...  

Aim: To examine the association between serum levels and effectiveness of omalizumab in patients with chronic spontaneous urticaria (CSU), and explore patient-specific factors associated with omalizumab pharmacokinetics. Methods: Patients with CSU, who were refractory to high-dose antihistamines and who initiated treatment with omalizumab (300 mg every four weeks) were eligible for the study. Treatment was evaluated every 4 week during 12 weeks of treatment with urticaria activity score in the past week (UAS7) as primary outcome and urticaria control test (UCT), Chronic Urticaria Quality of Life Questionnaire (CU QoL) and dermatology life quality index (DLQI) as secondary outcomes. Serum drug level of omalizumab was measured before (trough level) and at day seven (peak level) after each injection. Results: A total of 23 patients were included. After 12 weeks of treatment with omalizumab, an improvement of 16.8 UAS7 points (95% CI 10.8-22.8), p<0.001 was seen. The omalizumab trough and peak levels were 7.0-33.1 µg/mL and 11.4-54.0 µg/mL and reached a plateau (steady state) after 8-12 weeks of treatment. Among the patient-specific factors measured at baseline (age, sex, body mass index (BMI), angioedema, basophil histamine release (HR) test, blood basophils and eosinophils, and serum total IgE), BMI was the only significant predictor of omalizumab peak concentrations during the study (difference -2.75, p<0.05), whereas omalizumab trough concentrations were significantly associated with UAS7 scores (difference -0.82, p<0.001). The same was observed for UCT, DLQI, and CU QoL. Conclusion: In patients with CSU initiating treatment with omalizumab, a higher BMI predicts lower peak concentrations of omalizumab during treatment, whereas lower trough concentrations of omalizumab are associated with a poorer response on UAS7 and other patient reported outcomes.


10.29007/hvqg ◽  
2019 ◽  
Author(s):  
Joshua Twiggs ◽  
Edgar Wakelin ◽  
Justin Roe ◽  
Brett Fritsch ◽  
Brad Miles

A promising measure of dynamic outcomes in Total Knee Arthroplasty (TKA) is the simulation of joint dynamics. These simulations are potentially useful for pre-operative planning, but are not yet validated for patient-specific variations in anatomy, which forms the aim of this paper. 284 patients from a database of total knee arthroplasty patients were analysed using a pre-operatively defined simulation predicting post-operative knee dynamics; each patient had previously undergone pre- and post-operative CT imaging and had been assessed using the Knee Injury and Osteoarthritis Outcome (KOOS) score at 6 months following surgery. A significant correlation was found between the simulated contact force and laxity in mid-flexion (r=-0.452, p&lt;0.0001), and between the medio- lateral difference in contact force and difference in distal-vs-posterior femoral collateral ligament offset (r=-0.473, p&lt;0.0001). A significant difference of 5 KOOS pain points (p=0.02) was found for patients with unusually low or high simulated contact force compared to normal. These results indicate the preoperative simulation is capable of distinguishing patient-specific kinematics prior to surgery, thereby demonstrating the utility of this simulation for making pre-surgical predictions of patient-specific kinematics and patient-reported outcomes.


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Salma S. Al Sharhan ◽  
Mohammed H. Al Bar ◽  
Shahad Y. Assiri ◽  
Assayl R. AlOtiabi ◽  
Deemah M. Bin-Nooh ◽  
...  

Abstract Background Chronic rhinosinusitis (CRS) is a common inflammation of the nose and the paranasal sinuses. Intractable CRS cases are generally treated with endoscopic sinus surgery (ESS). Although the effect of ESS on CRS symptoms has been studied, the pattern of symptom improvement after ESS for CRS is yet to be investigated. The aim of this study was to determine the magnitude and sequence of symptom improvement after ESS for CRS, and to assess the possible preoperative factors that predict surgical outcomes in CRS patients. Methods This was a longitudinal prospective study of 68 patients who had CRS (with or without nasal polyps). The patients underwent ESS at King Fahd Hospital of the University, Al Khobar, Saudi Arabia. The Sino-nasal Outcome Test-22 (SNOT-22) questionnaire was used for assessment at four time points during the study: pre-ESS, 1-week post-ESS, 4 weeks post-ESS, and 6 months post-ESS. Results The difference between the mean scores recorded for the five SNOT-22 domains pre-ESS and 6 months post-ESS were as follows: rhinologic symptoms (t-test = 7.22, p-value =  < 0.001); extra-nasal rhinologic symptoms (t-test = 4.87, p-value =  < 0.001); ear/facial symptoms (t-test = 6.34, p-value =  < 0.001); psychological dysfunction (t-test = 1.99, p-value = 0.049); and sleep dysfunction (t-test = 5.58, p-value =  < 0.001). There was a significant difference between the mean scores recorded for the five domains pre-ESS and 6 months post-ESS. Rhinologic symptoms had the largest effect size (d = 1.12), whereas psychological dysfunction had the least effect size (d = 0.24). The only statistically significant difference in the SNOT-22 mean scores recorded 4 weeks post-ESS was observed between allergic and non-allergic patients (t = − 2.16, df = 66, p = 0.035). Conclusion Understanding the pattern of symptom improvement following ESS for CRS will facilitate patient counselling and aid the optimization of the current treatment protocols to maximize surgical outcomes and quality of life. Level of evidence Prospective observational.


2020 ◽  
Vol 12 ◽  
pp. 175883592097411
Author(s):  
Natalie Reizine ◽  
Everett E. Vokes ◽  
Ping Liu ◽  
Tien M. Truong ◽  
Rita Nanda ◽  
...  

Background: Many cancer patients who receive chemotherapy experience adverse drug effects. Pharmacogenomics (PGx) has promise to personalize chemotherapy drug dosing to maximize efficacy and safety. Fluoropyrimidines and irinotecan have well-known germline PGx associations. At our institution, we have delivered PGx clinical decision support (CDS) based on preemptively obtained genotyping results for a large number of non-oncology medications since 2012, but have not previously evaluated the utility of this strategy for patients initiating anti-cancer regimens. We hypothesize that providing oncologists with preemptive germline PGx information along with CDS will enable individualized dosing decisions and result in improved patient outcomes. Methods: Patients with oncologic malignancies for whom fluoropyrimidine and/or irinotecan-inclusive therapy is being planned will be enrolled and randomly assigned to PGx and control arms. Patients will be genotyped in a clinical laboratory across panels that include actionable variants in UGT1A1 and DPYD. For PGx arm patients, treating providers will be given access to the patient-specific PGx results with CDS prior to treatment initiation. In the control arm, genotyping will be deferred, and dosing will occur as per usual care. Co-primary endpoints are dose intensity deviation rate (the proportion of patients receiving dose modifications during the first treatment cycle), and grade ⩾3 treatment-related toxicities throughout the treatment course. Additional study endpoints will include cumulative drug dose intensity, progression-free survival, dosing of additional PGx supportive medications, and patient-reported quality of life and understanding of PGx. Discussion: Providing a platform of integrated germline PGx information may promote personalized chemotherapy dosing decisions and establish a new model of care to optimize oncology treatment planning.


2021 ◽  
pp. 1-8
Author(s):  
Emily Kell ◽  
John A. Hammond ◽  
Sophie Andrews ◽  
Christina Germeni ◽  
Helen Hingston ◽  
...  

OBJECTIVES: Shoulder pain is a common musculoskeletal disorder, which carries a high cost to healthcare systems. Exercise is a common conservative management strategy for a range of shoulder conditions and can reduce shoulder pain and improve function. Exercise classes that integrate education and self-management strategies have been shown to be cost-effective, offer psycho-social benefits and promote self-efficacy. This study aimed to examine the effectiveness of an 8-week educational and exercise-based shoulder rehabilitation programme following the introduction of evidence-based modifications. METHODS: A retrospective evaluation of a shoulder rehabilitation programme at X Trust was conducted, comparing existing anonymised Shoulder Pain and Disability Index (SPADI) and Patient-Specific Functional Scale (PSFS) scores from two cohorts of class participants from 2017-18 and 2018-19 that were previously collected by the physiotherapy team. Data from the two cohorts were analysed separately, and in comparison, to assess class efficacy. Descriptive data were also analysed from a patient satisfaction survey from the 2018-19 cohort. RESULTS: A total of 47 patients completed the 8-week shoulder rehabilitation programme during the period of data collection (2018-2019). The 2018-19 cohort showed significant improvements in SPADI (p 0.001) and PSFS scores (p 0.001). No significant difference was found between the improvements seen in the 2017-18 cohort and the 2018-19 cohort. 96% of the 31 respondents who completed the patient satisfaction survey felt the class helped to achieve their goals. CONCLUSION: A group-based shoulder rehabilitation class, which included loaded exercises and patient education, led to improvements in pain, disability and function for patients with rotator cuff related shoulder pain (RCRSP) in this outpatient setting, but anticipated additional benefits based on evidence were not observed.


Diagnostics ◽  
2020 ◽  
Vol 11 (1) ◽  
pp. 46
Author(s):  
Mattias Ulmner ◽  
Rachael Sugars ◽  
Aron Naimi-Akbar ◽  
Nikolce Tudzarovski ◽  
Carina Kruger-Weiner ◽  
...  

Our knowledge of synovial tissues in patients that are scheduled for surgery as a result of temporomandibular joint (TMJ) disorders is limited. Characterising the protein profile, as well as mapping clinical preoperative variables, might increase our understanding of pathogenesis and forecast surgical outcome. A cohort of 100 patients with either disc displacement, osteoarthritis, or chronic inflammatory arthritis (CIA) was prospectively investigated for a set of preoperative clinical variables. During surgery, a synovial tissue biopsy was sampled and analysed via multi-analytic profiling. The surgical outcome was classified according to a predefined set of outcome criteria six months postoperatively. Higher concentrations of interleukin 8 (p = 0.049), matrix metalloproteinase 7 (p = 0.038), lumican (p = 0.037), and tissue inhibitor of metalloproteinase 2 (p = 0.015) were significantly related to an inferior surgical outcome. Several other proteins, which were not described earlier in the TMJ synovia, were detected but not related to surgical outcome. Bilateral masticatory muscle palpation pain had strong association to a poor outcome that was related to the diagnoses disc displacement and osteoarthritis. CIA and the patient-reported variable TMJ disability might be related to an unfavourable outcome according to the multivariate model. These findings of surgical predictors show potential in aiding clinical decision-making and they might enhance the understanding of aetiopathogenesis in TMJ disorders.


2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Åsa Kettis ◽  
Hanna Fagerlind ◽  
Jan-Erik Frödin ◽  
Bengt Glimelius ◽  
Lena Ring

Abstract Background Effective patient-physician communication can improve patient understanding, agreement on treatment and adherence. This may, in turn, impact on clinical outcomes and patient quality of life (QoL). One way to improve communication is by using patient-reported outcome measures (PROMs). Heretofore, studies of the impact of using PROMs in clinical practice have mostly evaluated the use of standardized PROMs. However, there is reason to believe that individualized instruments may be more appropriate for this purpose. The aim of this study is to compare the effectiveness of the standardized QoL-instrument, the European Organization for Research and Treatment of Cancer Quality of Life C-30 (EORTC-QOL-C30) and the individualized QoL instrument, the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), in clinical practice. Methods In a prospective, open-label, controlled intervention study at two hospital out-patient clinics, 390 patients with gastrointestinal cancer were randomly assigned either to complete the EORTC-QOL-C30 or the SEIQoL-DW immediately before the consultation, with their responses being shared with their physician. This was repeated in 3–5 consultations over a period of 4–6 months. The primary outcome measure was patients’ health-related QoL, as measured by FACIT-G. Patients’ satisfaction with the consultation and survival were secondary outcomes. Results There was no significant difference between the groups with regard to study outcomes. Neither intervention instrument resulted in any significant changes in health-related QoL, or in any of the secondary outcomes, over time. This may reflect either a genuine lack of effect or sub-optimization of the intervention. Since there was no comparison to standard care an effect in terms of lack of deterioration over time cannot be excluded. Conclusions Future studies should focus on the implementation process, including the training of physicians to use the instruments and their motivation for doing so. The effects of situational use of standardized or individualized instruments should also be explored. The effectiveness of the different approaches may depend on contextual factors including physician and patient preferences.


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